Hemorrhagia Postpartum (HPP)

Initiatief: NVOG Aantal modules: 11

Stollingscorrectie bij HPP

Publicatiedatum: 12-12-2025
Beoordeeld op geldigheid: 12-12-2025

Uitgangsvraag

Wat is het effect van stollingscorrectie op basis van trombo-elastografie/metrie (TEG/ ROTEM) vergeleken met stollingscorrectie op basis van standaard laboratoriumtests bij HPP?

Aanbeveling

Hanteer bij patiënten met postpartum bloedingen het lokale HPP behandelprotocol. Neem lab af en zet traditionele stollingstesten of TEG/ ROTEM in om beleid t.a.v. stollingscorrectie daarop af te stemmen. Gebruik zwangerschap specifieke normaalwaarden voor TEG/ROTEM.

 

Voor de identificatie van risicofactoren voor HPP en de behandeling van HPP wordt verwezen naar de Fluxus Implementatie Strategie en naar het modelprotocol behandeling van HPP.

Overwegingen

Inleiding

In deze module wordt de uitgangsvraag onderzocht waarbij stollingscorrectie op basis van trombo-elastografie/metrie (TEG/ ROTEM) werd vergeleken met stollingscorrectie op basis van standaard laboratoriumtesten bij haemorrhagia postpartum (HPP). Stollingsafwijkingen (coagulopathie) zijn een van de minst voorkomende oorzaken van postpartum-bloedingen. Het is echter van belang om met behulp van laboratoriumtesten op het gebied van hemostase deze coagulopathie tijdig aan te tonen en de eventuele behandeling te monitoren.

 

Meerdere studies laten zien (Gilissen et al 2018, de Loyd et al, 2022, Schol et al 2021) dat afwijkingen in de stolling, gemeten met standaardtesten en/of TEG/ROTEM, relatief ongewoon zijn en dat de meeste vrouwen een adequate hemostase behouden, volgens deze test uitslagen, tot vaak grote hoeveelheden bloedverlies (> 2-3L). Een kleine subgroep van vrouwen met HPP vertoont echter wel een duidelijke, ernstige coagulopathie die o.a. wordt gekenmerkt door hyperfibrinolyse en hypo- en/of dysfibrinogenemie (de Loyd et al 2022).

 

Deze module heeft de literatuur vergeleken waarin enerzijds standaard laboratoriumtesten in plasma worden gebruikt om coagulopathie aan te tonen en/of te vervolgen t.b.v. behandeling (denk hierbij aan aPTT, PT, fibrinogeen bepaling volgens Clauss, aantal trombocyten) versus een volbloed methode op basis van tromboelastografie/metrie (TEG/ROTEM). Verschillen tussen deze standaard testen en de TEG/ROTEM zijn: de snelheid van de beschikbaarheid van de uitslag (volbloed is sneller en Point of Care beschikbaar) én de informatie die de testuitslag levert over de hemostase (de standaard testen leveren andere informatie dan de TEG/ROTEM).

 

Voor- en nadelen van de interventie en de kwaliteit van het bewijs

De werkgroep heeft een literatuurstudie verricht naar de (on)gunstige effecten van stollingscorrectie op basis van trombo-elastografie/metrie (TEG/ROTEM) in vergelijking met stollingscorrectie op basis van standaard laboratoriumtests of standaard beleid bij vrouwen met HPP.

 

In 2019 werd deze uitgangsvraag ook behandeld in de richtlijn Bloedtransfusie.

 

De conclusies in 2019 waren duidelijk voor de cardiothoracale chirurgie met als aanbeveling:

“maak gebruik van behandelalgoritmen op basis van TEG of ROTEM, als onderdeel van het behandelprotocol bij een acute bloeding ten gevolge van cardiothoracale chirurgie”.

 

Voor patiënten met post-partum-bloedingen waren er in 2019 nog onvoldoende gegevens beschikbaar om een conclusie te trekken over de effectiviteit van TEG of ROTEM. Het advies was destijds om het lokale behandelprotocol voor PPH te volgen.

In 2019 werd wel een algemeen advies gegeven wat als volgt werd geformuleerd: “Behandel patiënten met een dreigende verbloedingsshock volgens het massaal transfusieprotocol. Neem lab af en zet (indien beschikbaar) TEG of ROTEM in. Stel beleid bij op geleide van stollingsparameters en/of TEG of ROTEM.”

 

We zien geen verschil in bloedverlies tussen de interventie (ROTEM/TEG) en de controle groep. Dit geldt ook voor de bloedtransfusies van erytrocyten concentraten (RBC) en trombocyten concentraten. Echter, we zien duidelijk minder plasma (lees Gepoold SD-behandeld plasma oftewel PSD Plasma in NL) verbruik in de interventiegroep (ROTEM/TEG) terwijl het verbruik van fibrinogeen iets lijkt toe te nemen in deze groep. Deze laatste bevinding wordt vaker gezien bij het gebruik van zogenaamde “goal directed algoritmen met ROTEM/TEG” omdat sneller duidelijk wordt dat het fibrinogeen verlaagd is.

 

Er lijkt er geen verschil te zijn in de uitkomstmaat hysterectomie tussen stollingscorrectie op basis van trombo-elastografie/metrie of op basis van standaard laboratoriumtesten. Dit terwijl er minder IC opnames zijn bij gebruik van ROTEM of TEG.

 

Ondanks dat er geen significant verschil is gevonden in bloedverlies en bloedtransfusies van erytrocyten en trombocyten in de gerandomiseerde studies, liet de studie van Jokinen wel een significant verschil in plasma verbruik zien en een klein maar significant relevant verschil in totaal bloedverlies ten gunste van de ROTEM groep.

Uit geen enkele studie is gebleken dat het gebruik van TEG of ROTEM tot slechtere uitkomsten leidt dan het standaard beleid.

Voordeel van de interventie is dat de uitslagen sneller bekend zijn, omdat het testbloed niet  gecentrifugeerd  hoeft te worden tot plasma en bed side gemeten kan worden.

Hierdoor kun je sneller en makkelijker “goal directed” werken waardoor minder vaak zonder (blind) bekendheid van laboratoriumuitslagen behandeld wordt. De standaard protocollen voor groot bloedverlies (massaal transfusie protocol) bevatten meer plasma dan bij een gerichte “goal-directed” behandeling door snelle beschikbaarheid van ROTEM of TEG uitslagen. Minder bloedproducten transfunderen reduceert, in het algemeen, het risico op bloedtransfusiereacties. Aan de andere kant, bij het huidige gebruik van Omniplasma als standaard plasma product in Nederland is het risico op transfusiereacties bij dit specifieke bloedproduct al heel klein.

Het nadeel van de interventie is de investering (zie kosten) van de apparatuur en hogere kosten voor de prijs per test.

 

Waarden en voorkeuren van patiënten (en evt. hun verzorgers)

In de acute situatie van HPP wil je als patiënt kunnen vertrouwen op een snelle en accurate uitslag, waarbij de best beschikbare test wordt ingezet. Een snelle en betrouwbare test maakt het mogelijk om de behandeling onmiddellijk in te zetten, wat weer positief bijdraagt aan het herstel van de patiënt. Dit ondersteunt ook haar welzijn in de periode waarin zij voor haar baby wil zorgen.

 

Kosten (middelenbeslag)

Kostenbesparing

Op basis van de TEG/ROTEM-uitslagen kan de behandeling (zoals toediening van bloedproducten) specifieker worden afgestemd op de behoeften van de patiënt, bijvoorbeeld door het gericht toedienen van fibrinogeen, trombocyten of plasma. Door de focus te leggen op functionele stolling kan het risico op over- of onder behandeling verminderen. Dit zou kostenbesparend kunnen werken. Alleen de observationele studies lieten zien dat er in de interventie groep minder bloedverlies was, een lagere ratio hysterectomie en minder postoperatieve IC opname nodig was. Tevens een reductie in ziekenhuisopnames en over de gehele opnameperiode minder ziekenhuisopnamekosten (Snegosvkikh). McNamara liet een vermindering van bloedproducten zien en daarbij minder transfusie gerelateerde complicaties (significant) met minder IC opnames (niet-significant), wat mogelijk wel minder kosten met zich meebrengt.

 

Investering en testkosten

De interventie (ROTEM of TEG) vergt een uitbreiding van hardware, procedures, technische training, training t.b.v. de interpretatie van de uitslagen en brengt hierdoor extra eenmalige investeringskosten met zich mee.

Aan de andere kant kan een volledig ROTEM of TEG profiel dusdanige informatie geven waardoor de aPTT, PT, fibrinogeen en trombocytentelling kunnen vervallen.

Echter, de standaard laboratoriumtesten (aPTT, PT, fibrinogeen, trombocyten bepaling) komen niet te vervallen voor het betreffende laboratorium/ziekenhuis omdat ze complementair zijn/blijven voor andere indicaties en ziektebeelden.

De kostprijs van de interventie test ligt doorgaans hoger dan de prijs van de standaard (traditionele stollings) testen.

De NZA geeft de volgende kostprijzen:

 

Traditionele stollingsparameters (NZA 2025):

  • Protrombinetijd (PT): Euro 5,37
  • geactiveerde partiele tromboplastine tijd (aPTT): Euro 4,87
  • Fibrinogeen (Clauss):  Euro 6,21
  • Trombocytentelling: Euro 2,28

Tromboelastogram (NZA 2024):

  • Euro 30,58 (eerste onderzoek)
  • Euro 30,69 (herhalingen)

Ziekenhuizen kunnen echter andere kostprijzen voor bovenstaande standaard- en interventietesten hanteren dan bovenstaande genoemde tarieven, waardoor de verschillen met de traditionele stollingstesten zowel hoger als lager kunnen zijn. Daarnaast kan er verschil zijn tussen de ziekenhuizen in het doorberekenen van alleen de FIBTEM (als deze als enige is aangevraagd) versus het doorberekenen van alle testen van de cartridge (INTEM, EXTEM, FIBTEM, APTEM) omdat die automatisch allemaal uitgevoerd worden. Ook de locatie van het apparaat (centraal of decentraal) kan een lokaal prijsverschil geven.

 

De pre-analytische (volbloed i.p.v. plasma) en analytische stappen (eenvoudige point of care in de volbloed buis) om tot een uitkomst te komen zijn echter eenvoudiger en sneller. Afhankelijk van de grootte van het ziekenhuis en aantal patiënten zal het niet mogelijk zijn op alle relevante plaatsen in het ziekenhuis te beschikken over een TEG of ROTEM of zal de toepassing op een centrale plaats voor deze analysemethode moeten volgen in plaats van direct naast het bed. Dit kan ten koste gaan van de snelheid tenzij er goede logistieke afspraken (transport van monsters per buizenpost) worden gemaakt. Het centraal plaatsen van laboratoriumapparaat kan de betrouwbaarheid en kwaliteit(controles) van de uitslagen bevorderen.

 

De kostprijs voor TEG/ROTEM is hoger dan standaard laboratoriumtesten, maar de snelle beschikbaarheid van de resultaten zou mogelijk kunnen resulteren in betere uitkomsten van behandeling omdat de protocollen hierdoor beter gevolgd kunnen worden.

 

Aanvaardbaarheid, haalbaarheid en implementatie

Huidige beschikbaarheid en gevolgen van implementatie ROTEM of TEG

Het gebruik van ROTEM of TEG vergt een goede samenwerking tussen laboratorium en kliniek rondom de aanschaf, implementatie van algoritmes, kwaliteitsborging, structurele training en bijscholing (technisch en vakinhoudelijk) van alle professionals die betrokken zijn bij de behandeling van de bloedende patiënt. Deze samenwerking kan de bewustwording en continue verbetering van behandelalgoritmen voor alle soorten massale bloedingen (trauma, peri- operaties, spontane bloedingen en bij HPP) vergroten. Daarnaast, het beschikken over TEG of ROTEM zal leiden tot snellere beschikbaarheid van stollingsuitslagen t.o.v. de traditionele uitslagen van trombocytengetal, aPTT, PT en fibrinogeen uitslag waardoor het eigen ziekenhuisprotocol voor bloedingen of HPP beter kan worden opgevolgd. De snellere beschikbaarheid van uitslagen komt enerzijds doordat het om volbloed gaat wat geen laboratoriumbewerking nodig heeft en anderzijds omdat de uitslagen van TEG/ROTEM direct live te volgen zijn op beeldschermen in de kliniek.

 

De afkapwaarde voor de functionele fibrinogeen bepaling van een visco-elastische test (i.p.v. de Clauss fibrinogeen) is afhankelijk van het gebruik van het TEG of ROTEM en zelfs ook van het subtype van deze apparaten. Dit dient met het lokale laboratorium te worden afgestemd.

Bijvoorbeeld (uit een studie van Bell et al, 2025 bij HPP is gebleken):

ROTEM Delta:

  • FIBTEM A5 > 11 mm komt bij de meeste patiënten overeen met een fibrinogeen van ongeveer 2 g/L

ROTEM Sigma:

  • FIBTEM A5 > 11 mm komt bij de meeste patiënten overeen met een fibrinogeen van ongeveer 3 g/L

FIBTEM A5 > 8 mm komt bij de meeste patiënten overeen met een fibrinogeen van ongeveer 2 g/L

Onderbouwing

Early detection of changes in coagulation parameters allows for targeted transfusion with blood products (including red blood cells, Pooled Solvent-Detergent (treated) Plasma (PSD Plasma)[1], platelets, fibrinogen concentrate) to address any deficiencies in coagulation parameters during ongoing postpartum  bleeding. The standard coagulation tests (e.g. APTT, PT, fibrinogen (by Clauss method)) are often time-consuming in acute situations, such as postpartum haemorrhage (PPH), and may not guide clinical decisions quickly enough. Coagulation correction based on thromboelastography/metry (TEG/ROTEM), a point-of-care test that provides a qualitative assessment of blood coagulation, could help to enable rapid and targeted transfusion during PPH.

[1] ook wel bekend onder de merknaam Omniplasma/Octaplas LG

Very low GRADE

The evidence is very uncertain about the effect of a ROTEM-guided treatment on blood loss when compared with standard care guided treatment in women with PPH.

 

Source: Jokinen (2023), Lumbreras-Marquez (2022), Snegovskikh (2018)

 

Low GRADE

 

 

 

Low GRADE

 

 

Low Grade

 

 

Very low Grade

The evidence suggests that a ROTEM-guided treatment results in little to no difference on reducing RBC transfusion when compared with standard care guided treatment in women with PPH.

 

The evidence suggests that ROTEM-guided treatment reduces plasma transfusion when compared with standard care guided treatment in women with PPH.

 

The evidence suggests ROTEM reduces platelet transfusion when compared with standard care guided treatment in women with PPH.

 

The evidence is very uncertain about the effect of ROTEM-guided treatment on fibrinogen administration when compared with standard care guided treatment in women with PPH.

 

 

Source: Jokinen (2023), Lumbreras-Marquez (2022), Snegovskikh (2018), McNamara (2019)

 

Very low GRADE

The evidence is very uncertain about the effect of a ROTEM-guided treatment on hysterectomy when compared with standard care guided treatment in women with PPH.

 

Source: Jokinen (2023), Lumbreras-Marquez (2022), Snegovskikh (2018), McNamara (2019)

 

Very low GRADE

The evidence is very uncertain about the effect of a ROTEM-guided treatment on ICU admission when compared with standard care guided treatment in women with PPH.

 

Source: Lumbreras-Marquez (2022), Snegovskikh (2018), McNamara (2019)

  

Very low GRADE

The evidence is very uncertain about the effect of a ROTEM-guided treatment on coagulopathy when compared with standard care guided treatment in women with PPH.

 

Source: Lumbreras-Marquez (2022).

 

Very low GRADE

The evidence is very uncertain about the effect of a ROTEM-guided treatment on maternal death when compared with standard care guided treatment in women with PPH.

 

Source: McNamara (2019)

 

Very low GRADE

The evidence is very uncertain about the effect of a ROTEM-guided treatment on adverse effects when compared with standard care guided treatment in women with PPH.

 

Source: : Jokinen (2023), Lumbreras-Marquez (2022), McNamara (2019)

 

 

No GRADE

The outcome measures shock, organ dysfunction, women’s sense of wellbeing, acceptability and satisfaction with the intervention, breastfeeding and PTSD were not reported in the included studies. 

 

Source: none

Author

Design

Country

Sample size

Intervention

Control

Jokinen

2023)

RCT

Finland

54

ROTEM guided treatment

Conventional treatment

Lumbreras-Marquez (2022)

RCT

USA

49

ROTEM guided treatment

Standard care treatment

McNamara (2019)

Observational

retrospective trial (OT)

UK

255

ROTEM guided treatment

Shock pack treatment

Snegovskikh (2018)

Observational

retrospective (OT)

USA

86

ROTEM guided treatment

Not specified

RCT randomized controlled trial, OT observational trial

 

Description of studies

 

Randomized controlled trials (RCT)

Jokinen (2023) described a parallel design, randomized, controlled trial, which was conducted in Tampere University Hospital, Finland. 60 parturients aged > 18 years with PPH of more than 1500 mL, were randomized to receive either ROTEM-guided treatment (ROTEM-group) or standard care using clinical judgement and conventional coagulation testing (control group). In total 54 patients were included in the final analysis (ROTEM-group: 27; control group: 27), and the groups were comparable in several prognostic factors such as age (ROTEM-group: 32.8 (24-43); control group: 31.5 (24-43)) and BMI (ROTEM-group: 32.0 (6.42); control group: 29.8 (6.52)), but not in median blood loss before entering theatre, although not significant (ROTEM-group: 600 ml (2000 ml); control group: 1500 mL (1500 mL), p=0.118). The following relevant outcomes were reported: estimated blood loss, blood transfusion (RBC units transfused; median fresh frozen plasma transfused; number of women with platelets units transfused; number of women with any RBC blood transfusion; number of women with fresh frozen plasma transfused), adverse events and hysterectomy.

 

Lumbreras-Marquez (2022) described a single center randomized controlled trial of women aged 18-50 who experienced PPH with an estimated blood loss of ≥ 1000 mL and were admitted for delivery in the Brigham and Women’s Hospital, Boston, US. The authors analyzed the impact of ROTEM on the transfusion management of PPH. 23 patients were randomized in the ROTEM-group, and received standard of care plus ROTEM testing with results disclosed to the care team, and 26 patients were randomized in the control-group, and received standard of care plus ROTEM testing with ROTEM results undisclosed to the care team. Control participants had a lower gravidity, a higher percentage of white race, and a higher percentage of combined spinal epidural (CSE) anesthesia compared to participants in the ROTEM-group. The following relevant outcomes were reported: blood transfusion (median red blood cell (RBC) units transfused; median fresh frozen plasma transfused; median platelets units transfused; and median cryoprecipitate units transfused), incidence of coagulopathy, blood loss, hysterectomy, adverse events and transfer for higher level of care (reported as admission to the Intensive Care Unit (ICU) within two weeks of delivery).

 

Observational trials (OT)

McNamara (2019) described a 4-year retrospective observational cohort study with data from the Liverpool Women’s Hospital in the UK. The authors evaluated the difference in clinical outcomes and blood product use in patients with PPH and estimated blood loss ≥1500 mL who received either standard practice (shock pack group), consisting of a shock pack (four units of fresh frozen plasma (PLASMA), four units of packed RBC and one dose of platelets) at the onset of major obstetric haemorrhage, or a ROTEM algorithm (ROTEM-group). Included patients consisted of 203 patients that received the ROTEM-algorithm, and 52 patients that delivered before the introducing of the ROTEM-algorithm, and thereby received the standard practice. No baseline characteristics were available of women in both groups. The following relevant outcomes were reported: hysterectomy, total number of blood products administered (median RBC units transfused, median fresh frozen plasma units transfused; median cryoprecipitate units transfused; and median platelet units transfused), total volume of blood products administered, maternal death, adverse events and transfer for higher level of care (reported as number of ICU admissions).

Snegovskikh (2018) described a retrospective cohort study of patients with severe PPH managed at Yale-New Haven Hospital in New Haven, Connecticut, United States. Severe PPH was diagnosed if the estimated blood loss was 1500 mL or greater. Patients were divided in two cohorts: (i) those were blood product transfusion was guided by Point-of-Care Viscoelastic Testing (PCVT) performed using a ROTEM delta device (intervention group, n=28), and (ii) those for whom PCVT was not available, which included patients prior to May 1, 2014 as the PCVT-based protocol was introduced on this date, and those after that date if personnel trained in PCVT were not immediately available (control-group, n=58). For the 58 patients in the control group blood product transfusion was guided by standardized massive transfusion protocol. The two groups were comparable in several baseline characteristics including their age and BMI.  However, gynecologic oncologists were more commonly involved in the surgical management of patients in the control-group compared with patient in the intervention group (60.3% [35/58] vs 17.9% [5/28]; P < 0.001). Additionally, general anesthesia was provided more frequently in the control-group than in the intervention group (55.2% [32/58] vs 28.6% [8/28]; P = 0.04). The following relevant outcomes were reported: estimated blood loss, blood transfusion variables (number of patients with RBC units transfused, number of patients with fresh frozen plasma units transfused; number of patients with cryoprecipitate units transfused; and number of patients with platelet units transfused), hysterectomy, adverse events and transfer for higher level of care (reported as postoperative IC admission).

 

Results

 

Blood loss

RCT

Jokinen (2023) reported the outcome blood loss in the 57 patients with severe PPH. Patients in the ROTEM-group had a total median estimated blood loss of 2500 mL (2100 – 3000 ml), while patients in the control group had a total median estimated blood loss 3000 ml (2200 – 3100 ml) (p=0.033).

Lumbreras-Marquez (2022) reported no significant difference in the intention-to-treat analysis of the outcome total blood loss (EBL or QBL (mL), median (Q1, Q3) [min, max]) in the 49 patients with PPH that were either randomized in the ROTEM-group (2100 (1800, 2844) [1200, 10.000]) or the control-group (2000 (1500, 2600) [1000, 4743]), (p=0.228).

 

OT

Snegovskikh (2018) also reported the outcome estimated blood loss in 86 patients with severe PPH. The mean (IQR) estimated blood loss was 2000 ml (1600 – 2500 mL) in the intervention group and 3000 ml (2000 – 2400 ml) in the control-group (p <0.001).

 

Blood transfusion

RBC

RCT

Jokinen (2023): Median RBC units transfused was 2 (1-4) in the ROTEM group versus 3 (2-4) in the control group (p=0.399). The proportion of patients transfused was 77.8% (21/27) in the ROTEM group and 85.2% (23/27) in the control group (p=0.484).

Lumbreras-Marquez (2022): The median (Q1, Q3) RBC units transfused in the ROTEM group was 1 (0-4) [range: 0-16] compared to 2 (1-3) [range: 0-9] in the control group (p=0.594, effect size 0.84 [0.42-1.60]).

OT

McNamara (2019): The median RBC units transfused was 3 (2–5 [range: 0–14]) in the shock pack group and 3 (2–4 [range: 0–14]) in the ROTEM group (p=0.158).

Snegovskikh (2018): A higher proportion of patients in the ROTEM group (39.3%, 11/28) required no RBC transfusions compared to the control group (5.2%, 3/58), with 89.5% (52/58) in the control group needing two or more units, compared to 35.7% (10/28) in the ROTEM group (p < 0.001).

 

Plasma

Different plasma products were used in the four studies; Jokinen used Octaplas (a Pooled Solvent-Detergent (treated) Plasma) of 200 mL), Lumbreras-Marquez, McNamara and Snegovskikh used fresh frozen plasma (FFP, single donor, unit size can be variable). Therefore these products were defined as plasma in this module.

 

RCT

Jokinen (2023): 5 (18.5%) patients in the ROTEM group and 12 (44.4%) in the control group received plasma transfusions (p=0.040), with a median of 0 units in both groups (ROTEM: 0-0, control: 0-2; p=0.030).

Lumbreras-Marquez (2022): The median plasma units transfused was 0 (0-3) [range: 0-9] in the ROTEM group compared to 0 (0-2) [range: 0-9] in the control group (p=0.972, effect size 1.01 [0.57-1.81]).

OT

McNamara (2019): Median plasma units transfused was 4 (0–4 [range: 0–12]) in the shock pack group and 0 (0–0 [range: 0–8]) in the ROTEM group (p<0.0001).

Snegovskikh (2018): In the intervention group, 89.3% (25/28) required no plasma, compared to 27.6% (16/58) in the control group. In contrast, 72.4% (42/58) of the control group required  plasma, while only 10.7% (3/28) in the intervention group did (p < 0.001).

 

Platelets

Jokinen (2023): Platelet transfusion was required by 3 patients (11.1%) in both groups (p-value not reported).

RCT

Lumbreras-Marquez (2022): Median platelet units transfused was 0 (0-0) [range: 0-4] in the ROTEM group and 0 (0-0) [range: 0-2] in the control group (p=0.307, effect size 1.22 [0.84-1.80]).

 

OT

McNamara (2019): Median platelet transfusions were 0 (0–1 [range: 0–6]) in the shock pack group and 0 (0–0 [range: 0–4]) in the ROTEM group (p=0.007).

Snegovskikh (2018): All patients in the intervention group (100%, 28/28) avoided platelet transfusions, whereas 44.8% (26/58) of the control group required at least five units of platelets (p < 0.001).

 

Fibrinogen

RCT

Jokinen (2023): Fibrinogen transfusion was required by 4 (14.8%) in the ROTEM group and 7 (25.9%) in the control group (p=0.311).

Lumbreras-Marquez (2022): Median fibrinogen concentrate transfused was 0 (0,0) [range: 0-3] in the ROTEM group versus 0 (0,0) [range: 0-2] in the control group (p=0.833, effect size 1.04 [0.72-1.53]).

OT

McNamara (2019): The median fibrinogen transfusion was 0 (0–0 [range: 0–2]) in the shock pack group and 3 (0–3 [range: 0–18]) in the ROTEM group (p < 0.0001).

 

Hysterectomy

RCT

Jokinen (2023) reported the incidence of emergency hysterectomy (n(%)) in the 54 patients included in their final analysis. Two of the 27 women in the ROTEM-group (7.4%) and zero of the 27 women in the control group had an emergency hysterectomy (p=0.491).

Lumbreras-Marquez (2022) reported no significant difference in the number (%) of hysterectomy performed in the 49 patients with PPH that were either randomized in the ROTEM-group (13 (56.5%)) or the control-group (14 (53.8%)) (p=0.851).

 

OT

McNamara (2019) reported the outcome hysterectomy in a total of 255 patients with PPH. 16 of the 203 patients in the ROTEM-group (7.9%) had a hysterectomy compared to 7 of the 52 patients in the shock pack group (13.5%) (p=0.274).

 

Snegovskikh (2018) reported the incidence of puerperal hysterectomy in 86 patients with severe PPH and reported a significant difference in incidence (percentage[proportion]) between the intervention group (25% [7/28]) and the control-group (53.5% [31/58]) (p=0.013).

 

ICU admission (Transfer to higher level of care)

RCT

Lumbreras-Marquez (2022) reported no significant difference in the number (%) of ICU admissions in the 49 patients with PPH that were either randomized in the ROTEM-group (2 (8.7%)) or the control-group (1 (3.8%)) (p=0.594).

 

OT

McNamara (2019) reported the number (proportion) of ICU admissions in the 255 patients with severe PPH included in their cohort. No significant difference was found in the incidence of ICU admissions (percentage[proportion]) between the ROTEM-group (1.9% [4/203]) and the shock pack group (7.7% [4/52]),p=0.057).

 

Snegovskikh (2018) reported the incidence of postoperative ICU admissions in 86 patients with severe PPH. Indications for ICU admission included mechanical ventilation or congestive heart failure. They reported a significant difference in incidence (percentage[proportion]) between the intervention group (3.6% [1/28]) and the control-group (43.1% [25/58]) (p=0.001).

 

Shock

None of the studies described this outcome measure.

 

Coagulopathy

RCT

Lumbreras-Marquez (2022) reported the outcome coagulopathy (by ROTEM testing [Extem CT >90 s, Fibtem A10 <12 mm]; or by standard coagulation labs [PT >14.5 s, aPTT >36.6 s, international normalized ratio [INR] >1.1]) during PPH, which was rare in both groups. No significant difference was found in the number of subjects (%) with coagulopathy in the ROTEM-group (1(4.3%)) compared to the control-group (5 (19.2%)) (p = 0.194).

 

Organ dysfunction

None of the studies described this outcome measure.

 

Maternal death

McNamara (2019) reported the outcome death and found zero deaths in both groups.

 

Women’s sense of wellbeing

None of the studies described this outcome measure.

 

Acceptability and satisfaction with the intervention

None of the studies described this outcome measure.

 

Breastfeeding

None of the studies described this outcome measure.

 

Adverse effects

Transfusion reactions

RCT

Jokinen (2023) reported one transfusion-associated circulatory overload (TACO) in the ROTEM group. Fever was reported after transfusion in 4 (14.8%) subjects in each group. There were no reported thromboembolic complications.

 

Lumbreras-Marquez (2022) reported no transfusion-related acute lung injury (TRALI); and no TACO in both groups.

 

OT

McNamara (2019) reported 4 (7.7%) TACOs in the shock pack group and no events in the ROTEM group (p=0.002).

 

PTSD

None of the studies described this outcome measure.

 

Level of evidence of the literature

According to GRADE, systematic reviews of randomized controlled trials (RCTs) and RCTs start at a high level of evidence. Below are all outcomes that are reported in the two RCTs mentioned in the result section.

 

The level of evidence regarding the outcome measure blood loss was downgraded by two levels for risk of bias (selective reporting and early termination of the study), one level for inconsistency (different results compared to the other RCT, Lumbreras-Marquez) and one level for imprecision (optimal sample size not met) to very low GRADE.

 

The level of evidence regarding the outcome measure blood transfusion was downgraded by one level for risk of bias (early termination of study) and one level for imprecision (optimal sample size not met) to low GRADE.

 

The level of evidence regarding the outcome measure hysterectomy was downgraded by one level for risk of bias (early termination of study) and two level for imprecision (low event rate optimal sample size not met) to very low GRADE.

 

The level of evidence regarding the outcome measure ICU admission was downgraded by one level for risk of bias (no information provided on blinding of analyses) one level for inconsistency (different results compared to the Lumbreras-Marquez) and one level for imprecision (optimal sample size not met) to very low GRADE.

 

The level of evidence regarding the outcome measure coagulopathy was downgraded by one level for risk of bias (no information provided on blinding of analyses) and two level for imprecision (low event rate and optimal sample size not met) to very low GRADE.

 

According to GRADE, systematic reviews of observational studies and observational studies start at a low level of evidence.

 

As none of the studies selected for the summary of literature focused on shock, no GRADE conclusions could be drawn.

 

As none of the studies selected for the summary of literature focused on organ dysfunction, no GRADE conclusions could be drawn.

 

The level of evidence regarding the outcome measure maternal death was downgraded by two level for risk of bias (selection bias and lack of statistical analysis) and two level for imprecision (low event rate and low sample size) to very low GRADE.

 

As none of the studies selected for the summary of literature focused on women’s sense of wellbeing, no GRADE conclusions could be drawn.

 

As none of the studies selected for the summary of literature focused on acceptability and satisfaction with the intervention, no GRADE conclusions could be drawn.

 

As none of the studies selected for the summary of literature focused on breastfeeding, no GRADE conclusions could be drawn.

 

The level of evidence regarding the outcome measure adverse effects was downgraded by one level for risk of bias (early termination of study), one level for indirectness (transfusion-related reactions) and two level for imprecision (low event rate optimal sample size not met) to very low GRADE.

 

As none of the studies selected for the summary of literature focused on PTSD, no GRADE conclusions could be drawn.

A systematic review of the literature was performed to answer the following question: What is the effect of correction of coagulopathy based on thromboelastography/metry (TEG/ROTEM) in comparison with clotting correction based on standard laboratory tests in patients with postpartum  haemorrhage (PPH)?

P: Patients with PPH
I: Correction  of coagulopathy based on thromboelastography/metry (TEG/ROTEM)
C: Correction of coagulopathy based on clinical decision making and/or standard laboratory tests
O: Blood loss, shock, coagulopathy, hysterectomy, organ dysfunction, maternal death, blood transfusion, use of additional haemostatic intervention, transfer for higher level of care, women's sense of wellbeing, acceptability and satisfaction with the intervention, breastfeeding, adverse effects, and PTSD

Relevant outcome measures

The working group considered blood loss (continuous measure), shock, hysterectomy, organ dysfunction, blood transfusion, use of additional haemostatic intervention, transfer for higher level of care and maternal death as critical outcome measures for decision making; and coagulopathy, women's sense of wellbeing, acceptability and satisfaction with the intervention, breastfeeding, adverse effects and PTSD as important outcome measures for decision making.

 

A priori, the working group used definitions for the outcome measures listed above as described in the international Delphi consensus study by Meher (2018).

 

The working group defined a 1% difference for maternal death (RR < 0.99 or > 1.01) and a 10% (RR<0.9 or >1.1) difference for the other critical outcomes as a minimal clinically (patient) important difference.  For the other outcomes, a 25% difference for dichotomous outcomes (RR < 0.8 or > 1.25) and 0.5 SD for continuous outcomes was taken as minimal clinically (patient) important difference.

 

Search and select (Methods)

The databases Medline (via OVID) and Embase (via Embase.com) were searched with relevant search terms from 2000 until 16 November 2023. The detailed search strategy is depicted under the tab Methods. The systematic literature search resulted in 250 hits. Studies were selected based on the following criteria: systematic reviews, randomized controlled trials and observational (case-control and cohort) studies on thrombo-elastography or metry in women with persistent postpartum bleeding. 110 studies were initially selected based on title and abstract screening. After reading the full text, 106 studies were excluded (see the table with reasons for exclusion under the tab Methods), and four studies were included.

 

Results

Four studies were included in the analysis of the literature. Important study characteristics and results are summarized in the evidence tables. The assessment of the risk of bias is summarized in the risk of bias tables.

  1. Gillissen et al. TeMpOH-1 Study Group. Coagulation parameters during the course of severe postpartum haemorrhage: a nationwide retrospective cohort study. Blood Adv. 2018 Oct 9;2(19):2433-2442. doi: 10.1182/bloodadvances.2018022632. PMID: 30266818; PMCID: PMC6177656.
  2. de Lloyd L, Jenkins PV, Bell SF, Mutch NJ, Martins Pereira JF, Badenes PM, James D, Ridgeway A, Cohen L, Roberts T, Field V, Collis RE, Collins PW. Acute obstetric coagulopathy during postpartum haemorrhage is caused by hyperfibrinolysis and dysfibrinogenemia: an observational cohort study. J Thromb Haemost. 2023 Apr;21(4):862-879. doi: 10.1016/j.jtha.2022.11.036. Epub 2022 Dec 22. PMID: 36696216.
  3. Schol et al. Thromboelastometry in daily obstetric practice: At what amount of blood loss do we find abnormal results? A retrospective clinical observational study, Thrombosis Research, Volume 207, 2021, Pages 140-142, ISSN 0049-3848, https://doi.org/10.1016/j.thromres.2021.09.015.
Evidence table for intervention studies (randomized controlled trials and non-randomized observational studies [cohort studies, case-control studies, case series])1

Reasearch question: What is de effect of dotting correction based on thromboelastometry (TEG/ROTEM) in comparison with clotting correction based on standard laboratory tests in patients with postpartum heamorrhage (PPHH)?

Study reference

Study characteristics

Patient characteristics 2

Intervention (I)

Comparison / control (C) 3

 

Follow-up

Outcome measures and effect size 4

Comments

Jokinen, 2023

Type of study: Randomized, single-blind, controlled pilot study

 

Setting and country:

Participants recruited between 2016 up to 2019 from Tampere University Hospital, Finland.

 

Funding and conflicts of interest:

Funded by the Orion Research Foundation and Tampere University Hospital.

Inclusion criteria:

Parturient >18 years with severe postpartum haemorrhage (PPH) of > 1500 ml

 

Exclusion criteria:

  • Bleeding disorders
  • Refusal of allogeneic blood products.

 

N total at baseline:

Intervention: 30

Control: 30

 

Important prognostic factors2:

age ± range:

I: 32.8 (24-43)

C: 31.5 (24-43)

P=0.341

 

BMI ± SD:

I: 32.0 (6.42)

C: 29.8 (6.52)

P=0.208

 

Blood loss before entering theatre (ml), median (IQR):

I: 600 (2000)

C: 1500 (1500)

P=0.118

 

Groups comparable at baseline?

Yes

Describe intervention (treatment/procedure/test):

 

ROTEM-guided protocol

 

In detail: ROTEM Extem + Fibtem with blood count, fibrinogen, aPTT, INR and blood gas analysis

 

Describe  control (treatment/procedure/test):

 

Standard care using clinical judgement and conventional coagulation testing

 

In detail: Blood count, fibrinogen, aPTT, INR, blood gas analysis

 

 

Length of follow-up:

12-24 h after treatment.

 

Loss-to-follow-up/incomplete outcome data:

Intervention: 3/30

N (%) 27 (90%)

Reasons (describe)

  • Considered ineligible afterwards (abortion, n=1);
  • No confirmational consent (n=2)

 

Control: 3/30

N (%) 27 (90%)

Reasons (describe):

  • Considered ineligible afterwards (abortion, n=1);
  • Could not give consent (language barrier, n=1);
  • Critical data missing (n=1).

 

 

Outcome measures and effect size (include 95%CI and p-value if available):

 

Median (25th – 75th %) amount of transfused Red Blood Cells units:

I: 2 (1-4)

C: 3 (2-4)

P=0.399

 

Number (%) of subjects transfused:

I: 21 (77.8%)

C: 23 (85.2)

P=0.484

 

Median (25th – 75th %) amount of OctaplasLG® units:

I: 0 (0-0)

C: 0 (0-2)

P=0.030

 

Number (%) of subjects transfused OctaplasLG® units only:

I: 5 (18.5%)

C: 12 (44.4%)

P=0.040

 

Sulprostone infusion, n (%):

I: 2 (7.4%)

C: 8 (29.6%)

P=0.036

 

Total estimated blood loss:

I: 2500 (2100-3000)

C: 3000 (2200 – 3100)

P=0.033

Words from author:

‘’ROTEM-guided treatment of postpartum haemorrhage could have a plasma-sparing effect but possibly only

a small reduction in total blood loss.’’

 

Use of ROTEM® thromboelastometry might decrease administration

of plasma by avoiding unnecessary OctaplasLG®

transfusions.

 

“Subjects had a mean RBC transfusion amount of 2.6 units

(SD, 1.67), which is less than our assumed amount; thus the

sample size was insufficient.”

 

 

McNamara, 2019

Type of study:

Retrospective observational study

 

Setting and country:

Liverpool Women’s Hospital, United Kingdom.

 

 

Funding and conflicts of interest:

One of the authors has received travel expenses and honoraria from

Tem International/Werfen for talks given in relation to

viscoelastometric testing. Another author has received travel expenses

from Werfen to attend a meeting. No other conflicts of

interest.

 

Inclusion criteria:

  • Women with major obstetric haemorrhage (≥ 1500 ml with ongoing bleeding or signs of clinical shock)  and coagulopathy (defined as a ROTEM FibTEM A5 value of ≤ 12 mm).

 

Exclusion criteria:

  • Not mentioned

 

N total at baseline:

Intervention: 203

Control: 52

 

 

Groups comparable at baseline?

No information provided

 

 

Describe intervention (treatment/procedure/test):

 

ROTEM algoritm, with fibrinogen concentrate given to those with a FibTEM A5 value of <7 mm, or 7-12 mm with ongoing or high risk of haemorrhage.

Describe  control (treatment/procedure/test):

 

Standard practice: shock pack at the onset of major obstetric heamorrhage. Containing four units of fresh frozen plasma, four units of packed red blood cells, and one dose of platelets.

Length of follow-up:

I: women who met criteria between 1 July 2012 and 31 July 2016

 

C: women who met criteria between 1 April 2011 and 31 March 2012.

 

Loss-to-follow-up/incomplete outcome data:

In both groups there was no loss to follow up or incomplete outcome data.

 

 

Outcome measures and effect size (include 95%CI and p-value if available):

 

Intensive Care Unit admission (number (proportion)):

I: 4 (1.9%)

C: 4 (7.7%)

P = 0.057

 

Hysterectomy (number (proportion)):

I: 16 (7.9%)

C: 7 (13.5%)

P=0.274

 

Total number of blood products administered (median ((IQR [range])):

I: 3 (2-5[0-26])

C: 6 (3-12 [0-32])

P= <0.0001

 

Red blood cells; units: median (IQR [range]:

I: 3 (2-4 [0-14])

C: 3 (2-5 [0-14])

P=0.158

 

Fresh frozen plasma; units: median (IQR [range]:

I: o (0-0 [0-14])

C: 4 (0-4 [0-12])

P < 0.001

 

Cryoprecipitate; units: median (IQR [range]:

I: 0 (0-0 [0-7])

C: 0 (0-2 [0-7])

P <0.001

 

Platelets; units: median (IQR [range]:

I: 0 (0-0 [0-4])

C: 0 (0-1 [0-6])

P=0.007

 

Total volume of blood products administered in L (median (IQR [range])):

I: 0.8 (0.6 – 1.9 [0-7.6])

C: 1.7 (0.8 – 3.1 [0-8.4])

P=0.0007

 

Maternal death:

I: 0

C: 0

Difference in sample size

 

 

Authors conclusion:

’we demonstrated improved clinical

outcomes for following by the selective use of fibrinogen

concentrate to treat coagulopathy identified using ROTEM (…). Use of an

algorithm with point-of-care testing allowed individualised

treatment, focusing on fibrinogen as one of the main factors

in obstetric haemorrhage, while avoiding the use of

unnecessary blood products with the associated morbidity

and mortality.’’

Snegovskikh, 2018

Type of study:

retrospective cohort

 

Setting and country:

Delivery room, postoperative recovery area, IC unit, Yale-new Haven Hospital in New Haven, Connecticut, United States.

 

 

Funding and conflicts of interest:

Not mentioned

Inclusion criteria:

  • Severe PPH (blood loss 1500 mL or greater)

Exclusion criteria:

Not mentioned

 

N total at baseline:

Intervention: 28

Control: 58

 

Important prognostic factors2:

age ± SD:

I: 35.0 ± 6.2

C: 33.3 ± 6.6

P=0.27

 

Body mass index ± SD:

I: 31.1 ± 5.9

C: 23.4 ± 8.0

P=0.43

 

Presence of gyn/oncologist:

I: 5 (17.9%)

C: 35 (60.3%)

P= < 0.001

 

General anasthesia:

I: 8 (28.6%)

C: 32 (55.2%)

P=0.04

 

 

Groups comparable at baseline?

No

 

Describe intervention (treatment/procedure/test):

 

Blood product transfusion was guided by Point-of-Care Viscoelastic Testing (PCVT) performed using a ROTEM delta device.

 

Between May 1, 2014 – July 31, 2015

Describe  control (treatment/procedure/test):

 

Blood product transfusion was guided by standardized massive transfusion protocol.

 

Between Januari 1, 2011 – April 30, 2014 + those after the date if personnel trained in PCVT were not immediately available.

Length of follow-up:

Not applicable, duration of birth

 

There was no loss-to-follow-up/incomplete outcome data.

 

Outcome measures and effect size (include 95%CI and p-value if available):

 

Amount of red blood cells (units) transfused, n(%)

P < 0.001

 

0 units

I: 11 (39.3%)

C:3 (5.2%)

 

1 unit

I: 7 (25.0%)

C: 3 (5.2%)

 

≥2 units

I: 10 (35.7%)

C: 52 (89.6%)

 

Amount of fresh frozen plasma (units) transfused, n(%)

P < 0.001

 

0 units

I: 25 (89.3%)

C: 16 (27.6%)

 

≥1 unit

I: 3 (10.7%)

C: 42 (72.4%)

 

Amount of crypoprecipitate (units) transfused, n(%)

P = 0.78

 

0 units

I: 22 (87.6%)

C: 47 (81%)

 

≥ 5 units

I: 6 (21.4%)

C: 11 (19%)

 

Amount of platelets (units) transfused, n(%)

P < 0.001

 

0 units

I: 28 (100%)

C: 32 (55.2%)

 

≥ 5 units

I: 0 (0%)

C: 26 (44.8%)

 

Estimated blood loss (Median [IQR])

I: 2000 [1600-2500]

C: 3000 [2000-4000]

P < 0.001

 

Incidence of puerperal hysterectomy:

I: 7/28 (25%)

C: 31/58 (53.5%)

P = 0.013

 

Postoperative IC admission:

I: 1/28 (3.6%)

C: 25/58 (43.1%)

P < 0.0001

 

Length of postpartum hospitalization

I: 4 [3-4]

C: 5 [4-6]

P=0.001

Authors conclusion:

PCVT-based goal-directed blood product replacement management was associated with substantial benefits over a standardized massive transfusion protocol both in terms of patient outcomes and cost of care.

 

The ability to demonstrate the

absence of clinically significant coagulopathy in real-time during surgery

allowed us to avoid unnecessary blood product transfusion. Not

only did patients managed with PCVT-based goal-directed therapy require

less blood product replacement, but this strategy was also associated

with improved patient outcomes and reduced cost of care.

 

We have shown that patients in the

PCVT cohort received significantly lower volumes of transfused blood

products, underwent fewer hysterectomies, were less frequently admitted

to the ICU, and had shorter hospitalizations as compared with those

managed using the more traditional empiric protocol. Not surprisingly,

direct hospitalization cost was also significantly reduced in these

patients.

Lumbreras-Marquez (2022)

Type of study: Single center randomized controlled trial (RCT)

 

Setting and country:

Brigham and Women’s Hospital. Boston, US.

 

Funding and conflicts of interest:

The study was funded by an unrestricted donation from the Hess

Foundation, which had no role in the study’s design, execution, analysis,

or manuscript preparation.

 

Michaela K. Farber has been a member of the Octapharma Advisory

Board since October 2021 and has received compensation for a

1 h session to date. All other authors declare that they have no known

competing financial interests or personal relationships that could

have influenced the work reported in this manuscript.

Inclusion criteria:

Women age 18−50 years with a singleton or multiple pregnancy admitted for delivery with ≥1 major or 2 moderate PPH risk factors were recruited

(see details in article).

 

Randomization was reserved for only those enrollees who experienced PPH.

 

Exclusion criteria:

  • A known coagulation defect before delivery (see details in article).
  • Being on anticoagulation,
  • refusing to accept transfusion (e.g., Jehovah’s Witness) were excluded.

N total at baseline:

Intervention: 23

Control: 26

 

Important prognostic factors2:

 

Based on a sample size of 26 patients per group, an absolute standardized difference greater than 0.38 was considered to indicate greater difference than would be expected by chance.

 

Age, mean ± range (min, max):

I: 36 ± 5 (26, 46)

C: 36 ± 5 (26, 46)

Standardized difference: -0.051

 

BMI, mean  ± SD (min, max):

I: 31 ± 6 (21, 46)

C: 34 ± 9 (21, 63)

Standardized difference: -0.317

 

Gravidity, median (Q1, Q3) [min,max]

I: 4 (2,5) [2,9]

C: 3 (2,4) [1,8]

Standardized difference: 0.409

 

Race, n (%)

White:

I: 13 (56.5)

C: 17 (70.8)

Black:

I: 5 (21.7)

C: 5 (20.8)

Asian:

I: 4 (17.4)

C:2 (8.3)

Hispanic or Latino:
I:1 (4.3)

C:0 (0)

Standardized difference: 0.429

 

Ethnicity, n (%):

Hispanic:

I: 3 (13.6)

C: 4 (18.2)

Non-Hispanic

I: 19 (86.4)

C:18 (81.8)

Standardized difference: -0.125

 

Groups comparable at baseline?

No. Control participants had lower gravidity, a different distribution of percentage of race (control more white), and a different distribution in percentage of anesthesia (control more combined spinal epidural).

Describe intervention (treatment/procedure/test):

 

Standard of care plus ROTEM testing with results disclosed to the

care team)

Describe  control (treatment/procedure/test):

 

 

Standard of care plus ROTEM testing with

results undisclosed)

Length of follow-up:

Recruitment period of 3.5-years.

 

Loss-to-follow-up/incomplete outcome data:

No loss to follow-up

 

 

Outcome measures and effect size (include 95%CI and p-value if available):

 

All variables are from the intention-to-treat analysis.

 

Blood loss, EBL of QBL (mL), median (Q1, Q3) [min,max]

I: 2100 (1800, 2844) [ 1200, 10.000]

C: 2000 (1500, 2600) [1000, 4743]

P=0.228

 

Total RBC transfused, median (Q1, Q3) [min, max]:

I: 1 (0,4) [0,16]

C: 2 (1,3) [0,9]

P=0.594

 

Total fresh frozen plasma transfused, median (Q1, Q3) [min, max]:

I: 0 (0,3) [0,9]

C: 0 (0,2) [0,9]

P=0.972

 

Total platelets transfused, median (Q1, Q3) [min, max]:

I: 0 (0,0) [0,4]

C: 0 (0,0) [0,2]

P=0.307

 

Total cryoprecipitate transfused, median (Q1, Q3) [min, max]:

I: 0 (0,0) [0,3]

C: 0 (0,0) [0,2]

P=0.846

 

Coagulopathy, n(%)

I: 1 (4.3%)

C: 5 (19.2%)

P = 0.194

 

ICU admission, n(%):

I: 2 (8.7%)

C: 1 (3.8%)

P = 0.594

 

Hysterectomy performed, n (%):

I: 13 (56.5)
C: 14 (53.8)

P=0.851

 

Length of stay (days), median (Q1, Q3) [min,max]

I: 4 (4,9) [3, 38]

C: 4 (4,5) [2,20]

P=0.258

Randomization without stratification.

 

PPH is defined as blood loss ≥ 1000 ml, all other studies used ≥ 1500 ml.

 

Small sample size. They based their statistical absolute standardized difference on 26 participants per arm. So the statistical values for baseline characteristics are not trustworthy.

 

Studie was stopped earlier:

With slower than anticipated accrual

rate of eligible participant randomization over the study period,

potential changes in contemporary management of PPH evolved

based on published cohort studies [13−16], and exposure to

ROTEM, even in cases in which ROTEM data was not available.

Therefore, the trial was stopped after 49 participants were randomized;

23 participants were allocated to the intervention group, and

26 to the control group

 

”Under these real-world circumstances, this RCT did

not identify a clinically important difference in the number of total

blood products transfused between the intervention and control

groups which contrasts with prior observational studies”’

 

Per protocol: Clinicians

caring for participants randomized to the intervention group

were provided ROTEM results and a management algorithm to

guide their transfusion choices, but adherence to the algorithm was

not mandated in our study and was inconsistent.

Risk of bias table for intervention studies (randomized controlled trials; based on Cochrane risk of bias tool and suggestions by the CLARITY Group at McMaster University)

Reasearch question: What is de effect of dotting correction based on thromboelastometry (TEG/ROTEM) in comparison with clotting correction based on standard laboratory tests in patients with postpartum heamorrhage (PPHH)?

Study reference

 

(first author, publication year)

Was the allocation sequence adequately generated?

 

 

 

 

 

 

 

 

 

 

 

Definitely yes

Probably yes

Probably no

Definitely no

Was the allocation adequately concealed?

 

 

 

 

 

 

 

 

 

 

 

Definitely yes

Probably yes

Probably no

Definitely no

Blinding: Was knowledge of the allocated

interventions adequately prevented?

 

Were patients blinded?

 

Were healthcare providers blinded?

 

Were data collectors blinded?

 

Were outcome assessors blinded?

 

Were data analysts blinded?

 

Definitely yes

Probably yes

Probably no

Definitely no

Was loss to follow-up (missing outcome data) infrequent?

 

 

 

 

 

 

 

 

 

 

 

Definitely yes

Probably yes

Probably no

Definitely no

Are reports of the study free of selective outcome reporting?

 

 

 

 

 

 

 

 

 

 

Definitely yes

Probably yes

Probably no

Definitely no

Was the study apparently free of other problems that could put it at a risk of bias?

 

 

 

 

 

 

 

 

 

 

Definitely yes

Probably yes

Probably no

Definitely no

Overall risk of bias

If applicable/necessary, per outcome measure

 

 

 

 

 

 

 

 

 

 

 

LOW

Some concerns

HIGH

 

Jokinen, 2023

Definitely yes,

 

Reason: Randomisation was done beforehand by an independent statistician using a random number generator.

Definitely yes

 

Reason: treatment protocol was put in a closed envelope

Definitely no

 

Reason: single-blinded trial. The anaesthesiologist treating the patient followed the protocol assigned to the patient in the envelope and was therefore not blinded.

 

All analyses on outcomes were blinded.

Definitely yes

 

Reason: Loss to follow-up was infrequent and similar in intervention and control group.

Probably yes, except for estimated blood loss, there definitely No.

 

Reason: Mean blood loss not reported in result section, only in discussion. 

Probably yes

 

Reason: Optimal sample size not met, and blood loss before entering theatre was greater in the control group and although not significantly different, it might have affected the total blood loss.

High concerns: outcome estimated blood loss

 

Some concerns: all other outcomes

Lumbreras-Marquez (2022)

Definitely yes,

 

Reason: The randomization schedule

was created using a computer-generated scheme, without stratification.

 

Definitely yes,

 

Reason: intervention

and control designations placed by a blinded observer in opaque,

sequentially numbered envelopes

Probably no,

 

Reason: No information provided on further blinding of the study and data analysis.

 

 

Definitely no,

 

Reason: Study was terminated early

Definitely yes,

 

Reason: all relevant outcomes were reported.

Optimal sample size not met, thus underpowered due to early termination of study.

 

Performance bias is a concern if the management changed over te course of the study period. In addition, the statistical significance in the comparison of baseline characteristics is based on a critical standardized difference based on a different sample size.

Some concern: all outcomes

Risk of bias table for interventions studies (cohort studies based on risk of bias tool by the CLARITY Group at McMaster University

Reasearch question: What is de effect of dotting correction based on thromboelastometry (TEG/ROTEM) in comparison with clotting correction based on standard laboratory tests in patients with postpartum heamorrhage (PPHH)?

Author, year

Selection of participants

 

Was selection of exposed and non-exposed cohorts drawn from the same population?

 

 

 

 

 

 

 

 

Exposure

 

 

Can we be confident in the assessment of exposure?

 

 

 

 

 

 

 

 

 

Outcome of interest

 

Can we be confident that the outcome of interest was not present at start of study?

 

 

 

 

 

 

 

Confounding-assessment

 

Can we be confident in the assessment of confounding factors? 

 

Confounding-analysis

 

Did the study match exposed and unexposed for all variables that are associated with the outcome of interest or did the statistical analysis adjust for these confounding variables?

 

Assessment of outcome

 

Can we be confident in the assessment of outcome?

 

 

 

 

 

 

 

 

 

Follow up

 

 

Was the follow up of cohorts adequate? In particular, was outcome data complete or imputed?

 

 

 

 

 

 

 

 

 

 

Co-interventions

 

Were co-interventions similar between groups?

 

 

 

 

 

 

 

 

 

 

Overall Risk of bias

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Definitely yes, probably yes, probably no, definitely no

Definitely yes, probably yes, probably no, definitely no

Definitely yes, probably yes, probably no, definitely no

Definitely yes, probably yes, probably no, definitely no

Definitely yes, probably yes, probably no, definitely no

Definitely yes, probably yes, probably no, definitely no

Definitely yes, probably yes, probably no, definitely no

Definitely yes, probably yes, probably no, definitely no

Low, Some concerns, High

McNamara, 2019

Definitely no,

 

Different population because different time frame.  Before and after introduction ROTEM guided algorithm (1 July 2012).

 

Performance bias is a concern if the management changed over te course of the study period

Definitely yes

 

Reason: Secure record because of protocol and hospital admission

 

Definitely yes 

 

Reason: outcome of interest was related to the proceding PPH management.

 

Probably no

 

Reason:

No other variables that might confound the data were collected

Probably yes

 

Reason: Case-control design. However, baseline variables were not provided, and not taken into account as no multivariate analysis were performed.

 

Probably yes

 

Reason:

Measured in hospital setting but no information on how it is measured. 

Definitely yes

 

Reason:

Follow-up full labor/surgery.

No co-interventions present

 

Some concerns for all outcomes

Snegovskikh, 2018

Definitely no,

 

Reason: cases and controls not drawn from the same population.

 

Performance bias is a concern if the management changed over te course of the study period

Definitely yes,

 

Reason: secure record because of protocol and hospital admission.

Definitely yes 

 

Reason: outcome of interest was related to the proceding PPH management.

 

Definitely yes,

 

Reason: relevant baseline characteriscs and other variables are measured

Probably yes

 

Reason: Case-control design. However, baseline variables were not taken into account as no multivariate analysis were performed.

 

Definitely yes

 

Reason:

Clear information provided in article.  

Definitely yes

 

Reason:

Follow-up full labor/surgery.

No co-interventions present

Some concerns for all outcomes

Table of excluded studies

References

Reason for exclusion

Aawar N, Alikhan R, Bruynseels D, Cannings-John R, Collis R, Dick J, Elton C, Fernando R, Hall J, Hood K, Lack N, Mallaiah S, Maybury H, Nuttall J, Paranjothy S, Rayment R, Rees A, Sanders J, Townson J, Weeks A, Collins P. Fibrinogen concentrate versus placebo for treatment of postpartum haemorrhage: study protocol for a randomised controlled trial. Trials. 2015 Apr 17;16:169. doi: 10.1186/s13063-015-0670-9. PMID: 25906770; PMCID: PMC4408576.

Design: study protocol

Affronti G, Agostini V, Brizzi A, Bucci L, De Blasio E, Frigo MG, Giorgini C, Messina M, Ragusa A, Sirimarco F, Svelato A. The daily-practiced post-partum hemorrhage management: an Italian multidisciplinary attended protocol. Clin Ter. 2017 Sep-Oct;168(5):e307-e316. doi: 10.7417/T.2017.2026. PMID: 29044353.

Management article

Agarwal S, Laycock HC. The debate ROTEMs on - the utility of point-of-care testing and fibrinogen concentrate in postpartum haemorrhage. Anaesthesia. 2020 Sep;75(9):1247-1251. doi: 10.1111/anae.15193. Epub 2020 Jul 14. PMID: 32662889.

Design: narrative review

Amgalan A, Allen T, Othman M, Ahmadzia HK. Systematic review of viscoelastic testing (TEG/ROTEM) in obstetrics and recommendations from the women's SSC of the ISTH. J Thromb Haemost. 2020 Aug;18(8):1813-1838. doi: 10.1111/jth.14882. PMID: 32356929.

Design: narrative review.

Viscoelastometric Point-of-Care Testing for Vascular Surgery and Obstetrics: A Review of Clinical Utility and Guidelines [Internet]. Ottawa (ON): Canadian Agency for Drugs and Technologies in Health; 2016 Jan 4. PMID: 26889535.

Wrong design

Antony KM, Mansouri R, Arndt M, Rocky Hui SK, Jariwala P, Mcmullen VM, Teruya J, Aagaard K. Establishing thromboelastography with platelet-function analyzer reference ranges and other measures in healthy term pregnant women. Am J Perinatol. 2015 May;32(6):545-54. doi: 10.1055/s-0034-1396700. Epub 2015 Jan 16. PMID: 25594216.

Wrong outcome measures

Arnolds DE, Scavone BM. Thromboelastographic Assessment of Fibrinolytic Activity in Postpartum Hemorrhage: A Retrospective Single-Center Observational Study. Anesth Analg. 2020 Nov;131(5):1373-1379. doi: 10.1213/ANE.0000000000004796. PMID: 33079858.

Wrong outcome measures

Bareille M, Lecompte T, Mullier F, Roullet S. Are Viscoelastometric Assays of Old Generation Ready for Disposal? Comment on Volod et al. Viscoelastic Hemostatic Assays: A Primer on Legacy and New Generation Devices. J. Clin. Med. 2022, 11, 860. J Clin Med. 2023 Jan 6;12(2):477. doi: 10.3390/jcm12020477. PMID: 36675406; PMCID: PMC9866463.

Wrong outcome measures

Barinov SV, Zhukovsky YG, Dolgikh VT, Medyannikova IV. Novel combined strategy of obstetric haemorrhage management during caesarean section using intrauterine balloon tamponade. J Matern Fetal Neonatal Med. 2017 Jan;30(1):29-33. doi: 10.3109/14767058.2015.1126242. Epub 2016 Jun 1. PMID: 26625194.

Wrong I

Belete M, Gerrans E, Keskar M. Blood management in post-partum haemorrhage, including point of care coagulation tests. Signa Vitae. 2021 May 1;17(3).

Design: narrative review

Bell SF, Collis RE, Bailey C, James K, John M, Kelly K, Kitchen T, Scarr C, Macgillivray E, Collins PW. The incidence, aetiology, and coagulation management of massive postpartum haemorrhage: a two-year national prospective cohort study. Int J Obstet Anesth. 2021 Aug;47:102983. doi: 10.1016/j.ijoa.2021.102983. Epub 2021 Mar 26. Erratum in: Int J Obstet Anesth. 2022 Aug;51:103549. doi: 10.1016/j.ijoa.2022.103549. PMID: 33994274.

No comparative study

Bell SF, Roberts TCD, Freyer Martins Pereira J, De Lloyd L, Amir Z, James D, Jenkins PV, Collis RE, Collins PW. The sensitivity and specificity of rotational thromboelastometry (ROTEM) to detect coagulopathy during moderate and severe postpartum haemorrhage: a prospective observational study. Int J Obstet Anesth. 2022 Feb;49:103238. doi: 10.1016/j.ijoa.2021.103238. Epub 2021 Nov 8. PMID: 34840018.

Wrong outcome measures

Bell SF, de Lloyd L, Preston N, Collins PW. Managing the coagulopathy of postpartum hemorrhage: an evolving role for viscoelastic hemostatic assays. J Thromb Haemost. 2023 Aug;21(8):2064-2077. doi: 10.1016/j.jtha.2023.03.029. Epub 2023 Apr 3. PMID: 37019365.

Design: case report

Belotserkovtseva, L. D. and Zinin, V. N. and Kovalenko, L. V. and Pankratov, V. V. Assessment of the effectiveness of “Patient Blood Management” approach in a level III maternity unit. Voprosy Ginekologii, Akusherstva i Perinatologii. 2022; 21(2), 75-82; doi:10.20953/1726-1678-2022-3-75-82

Language: Russian

Bunch CM, Berquist M, Ansari A, McCoy ML, Langford JH, Brenner TJ, Aboukhaled M, Thomas SJ, Peck E, Patel S, Cancel E, Al-Fadhl MD, Zackariya N, Thomas AV, Aversa JG, Greene RB, Seder CW, Speybroeck J, Miller JB, Kwaan HC, Walsh MM. The Choice between Plasma-Based Common Coagulation Tests and Cell-Based Viscoelastic Tests in Monitoring Hemostatic Competence: Not an either-or Proposition. Semin Thromb Hemost. 2022 Oct;48(7):769-784. doi: 10.1055/s-0042-1756302. Epub 2022 Sep 29. PMID: 36174601.

Design: narrative review

Butwick A, Lyell D, Goodnough L. How do I manage severe postpartum hemorrhage? Transfusion. 2020 May;60(5):897-907. doi: 10.1111/trf.15794. Epub 2020 Apr 22. PMID: 32319687.

Management article

Butwick A, Ting V, Ralls LA, Harter S, Riley E. The association between thromboelastographic parameters and total estimated blood loss in patients undergoing elective cesarean delivery. Anesth Analg. 2011 May;112(5):1041-7. doi: 10.1213/ANE.0b013e318210fc64. Epub 2011 Apr 7. PMID: 21474664.

No comparative study

Butwick AJ, Goodnough LT. Transfusion and coagulation management in major obstetric hemorrhage. Curr Opin Anaesthesiol. 2015 Jun;28(3):275-84. doi: 10.1097/ACO.0000000000000180. PMID: 25812005; PMCID: PMC4567035.

Design: narrative review

Chavan R, Latoo MY. Recent advances in the management of major obstetric haemorrhage. British Journal of Medical Practitioners. 2013 Mar 1;6(1).

Design: narrative review

Cheng SM, Lew E. Obstetric haemorrhage–Can we do better?. Trends in Anaesthesia and Critical Care. 2014 Aug 1;4(4):119-26.

Design: narrative review/management article

Collins P. Point-of-care coagulation testing for postpartum haemorrhage. Best Pract Res Clin Anaesthesiol. 2022 Dec;36(3-4):383-398. doi: 10.1016/j.bpa.2022.08.002. Epub 2022 Aug 20. PMID: 36513433.

Management article/narrative review

Collins P, Abdul-Kadir R, Thachil J; Subcommittees on Women' s Health Issues in Thrombosis and Haemostasis and on Disseminated Intravascular Coagulation. Management of coagulopathy associated with postpartum hemorrhage: guidance from the SSC of the ISTH. J Thromb Haemost. 2016 Jan;14(1):205-10. doi: 10.1111/jth.13174. Epub 2015 Dec 23. PMID: 27028301.

Design: narrative review/management article

Collins PW, Bell SF, de Lloyd L, Collis RE. Management of postpartum haemorrhage: from research into practice, a narrative review of the literature and the Cardiff experience. Int J Obstet Anesth. 2019 Feb;37:106-117. doi: 10.1016/j.ijoa.2018.08.008. Epub 2018 Aug 25. PMID: 30322667.

Design: narrative review

Collins, P. W. and Cannings-John, R. and Bruynseels, D. and Mallaiah, S. and Dick, J. and Elton, C. and Weeks, A. and Sanders, J. and Aawar, N. and Townson, J. and Hood, K. Collins PW, Cannings-John R, Bruynseels D, Mallaiah S, Dick J, Elton C, Weeks A, Sanders J, Aawar N, Townson J, Hood K, Hall J, Harding K, Gauntlett R, Collis R; OBS2 study collaborators. Viscoelastometry guided fresh frozen plasma infusion for postpartum haemorrhage: OBS2, an observational study. Br J Anaesth. 2017 Sep 1;119(3):422-434. doi: 10.1093/bja/aex245. PMID: 28969328.

No comparative study

Collins PW, Cannings-John R, Bruynseels D, Mallaiah S, Dick J, Elton C, Weeks AD, Sanders J, Aawar N, Townson J, Hood K, Hall JE, Collis RE. Viscoelastometric-guided early fibrinogen concentrate replacement during postpartum haemorrhage: OBS2, a double-blind randomized controlled trial. Br J Anaesth. 2017 Sep 1;119(3):411-421. doi: 10.1093/bja/aex181. PMID: 28969312.

Wrong comparison: fibrinogen concentrate vs. Placebo

Collis R, Bell S. The Role of Thromboelastography during the Management of Postpartum Hemorrhage: Background, Evidence, and Practical Application. Semin Thromb Hemost. 2023 Mar;49(2):145-161. doi: 10.1055/s-0042-1757895. Epub 2022 Nov 1. PMID: 36318958.

Design: narrative review

Collis R, Guasch E. Managing major obstetric haemorrhage: Pharmacotherapy and transfusion. Best Pract Res Clin Anaesthesiol. 2017 Mar;31(1):107-124. doi: 10.1016/j.bpa.2017.02.001. Epub 2017 Feb 9. PMID: 28625299.

Design: narrative review

Collis RE, Kenyon C, Roberts TCD, McNamara H. When does obstetric coagulopathy occur and how do I manage it? Int J Obstet Anesth. 2021 May;46:102983. doi: 10.1016/j.ijoa.2021.102983. PMID: 33775682.

Design: narrative review

David JS, Imhoff E, Parat S, Augey L, Geay-Baillat MO, Incagnoli P, Tazarourte K. Use of thrombelastography to guide posttraumatic hemostatic therapy: More coagulation factor concentrates and less allogenic blood transfusion? Anaesth Crit Care Pain Med. 2015 Dec;34(6):339-43. doi: 10.1016/j.accpm.2015.06.004. PMID: 26507909.

Language: French

De Lange NM, Van Rheenen-Flach LE, Lance MD, Mooyman L, Woiski M, Van Pampus EC, Porath M, Bolte AC, Smits L, Henskens YM, Scheepers HC. Peri-partum reference ranges for ROTEM thromboelastometry. Br J Anaesth. 2014 Jun;112(6):1093-101. doi: 10.1093/bja/aet557. PMID: 24554543.

Wrong outcome measures

Dias JD, Butwick AJ, Hartmann J, Waters JH. Viscoelastic haemostatic point-of-care assays in the management of postpartum haemorrhage: a narrative review. Anaesthesia. 2021 Aug;76 Suppl 4:120-131. doi: 10.1111/anae.15454. PMID: 33525056.

Design: narrative review

Drumheller BC, Stein DM, Moore LJ, Rizoli SB, Cohen MJ. Thromboelastography and rotational thromboelastometry for the surgical intensivist: A narrative review. J Trauma Acute Care Surg. 2019 Apr;86(4):710-721. doi: 10.1097/TA.0000000000002185. PMID: 30629007.

Design: narrative review

Ekelund K, Hanke G, Stensballe J, Wikkelsøe A, Albrechtsen CK, Afshari A. Hemostatic resuscitation in postpartum hemorrhage - A supplement to surgery. Acta Obstet Gynecol Scand. 2015 Jun;94(6):680-92. doi: 10.1111/aogs.12607. PMID: 25644927.

Design: narrative review

Eremeeva DR, Zainulina MS. Application of the rotational thromboelastography/thromboelastometry for assessment of massive obstetric blood loss in a high risk group. J Matern Fetal Neonatal Med. 2017 Jan;30(1):34-38. doi: 10.3109/14767058.2015.1126243. PMID: 26626538.

Language: Russian

Fan G, Yuan M, Niu H, Lu Y, Yang H, Liang X. The Significance of Thromboelastogram in Predicting Postpartum Hemorrhage and Guiding Blood Transfusion. Clin Lab. 2021 Dec 1;67(12). doi: 10.7754/Clin.Lab.2021.210317. PMID: 34915670.

This article has been retracted

Fan G, Yuan M, Niu H, Lu Y, Yang H, Liang X. Retraction of: The Significance of Thromboelastogram in Predicting Postpartum Hemorrhage and Guiding Blood Transfusion. Clin Lab. 2023 Feb 1;69(2). doi: 10.7754/Clin.Lab.2021.210399. PMID: 37470307.

Retracted paper

Fiol AG, Yoo J, Yanez D, Fardelmann KL, Salimi N, Alian M, Mancini P, Alian A. Baseline rotational thromboelastometry (ROTEM) values in a healthy, diverse obstetric population and parameter changes by pregnancy-induced comorbidities. Int J Obstet Anesth. 2022 Aug;51:103549. doi: 10.1016/j.ijoa.2022.103549. PMID: 35752594.

Wrong population: women undergoing vaginal or cesarean delivery with a history of or at risk for PPH. Exclusion criterium = active bleeding

Fudaba M, Tachibana D, Misugi T, Nakano A, Koyama M. Excessive fibrinolysis detected with thromboelastography in a case of amniotic fluid embolism: fibrinolysis may precede coagulopathy. J Obstet Gynaecol Res. 2021 Mar;47(3):1229-1233. doi: 10.1111/jog.14648. PMID: 33368864.

Design: case report

Görlinger K, Dirkmann D, Solomon C, Hanke AA. Fast interpretation of thromboelastometry in non-cardiac surgery: Reliability in patients with hypo-, normo-, and hypercoagulability. Br J Anaesth. 2017 May 1;118(5):755-764. doi: 10.1093/bja/aex058. PMID: 28403406.

Wrong population: patients undergoing non-cardiac surgery

Görlinger K, Pérez-Ferrer A, Dirkmann D, Saner F, Maegele M, Calatayud ÁAP, Kim TY. The role of evidence-based algorithms for rotational thromboelastometry-guided bleeding management. Korean J Anesthesiol. 2019 Dec;72(6):297-322. doi: 10.4097/kja.19169. PMID: 30929423.

Design: narrative review

Gehrie EA, Baine I, Booth GS. Pathology consultation on viscoelastic studies of coagulopathic obstetrical patients. Am J Clin Pathol. 2019 Jan 1;151(1):1-7. doi: 10.1093/ajcp/aqy101. PMID: 30285068.

Design: narrative review

Getrajdman C, Sison M, Lin HM, Katz D. The effects of hemodilution on coagulation in term parturients: an in vitro study utilizing rotational thromboelastometry. Int J Obstet Anesth. 2021 May;46:102983. doi: 10.1016/j.ijoa.2021.102983. PMID: 33775682.

No comparative study

Gillissen A, van den Akker T, Caram-Deelder C, Henriquez DDCA, Bloemenkamp KWM, Eikenboom J, van der Bom JG, de Maat MPM. Comparison of thromboelastometry by ROTEM Delta and ROTEM Sigma in women with postpartum haemorrhage. Int J Lab Hematol. 2021 Aug;43 Suppl 1:142-150. doi: 10.1111/ijlh.13445. PMID: 33522624.

Wrong outcome measures

Giouleka S, Tsakiridis I, Kalogiannidis I, Mamopoulos A, Tentas I, Athanasiadis A, Dagklis T. Postpartum Hemorrhage: A Comprehensive Review of Guidelines. Obstet Gynecol Surv. 2021 Oct;76(10):613-623. doi: 10.1097/OGX.0000000000000931. PMID: 34706105.

A review of guidelines

Gonzalez-Fiol A, Fardelmann KL, Yanez D, Salimi N, Mancini P, Alian A. Comparison between the Rotational Thromboelastometry (ROTEM) Delta device against the Cartridge-based Thromboelastography 6s and Quantra in a healthy third trimester pregnant cohort. Int J Obstet Anesth. 2022 Aug;51:103549. doi: 10.1016/j.ijoa.2022.103549. PMID: 35752594.

Wrong outcome measures

Graves S, Montemorano L, Rood K, Costantine MM, Fiorini K, Cackovic M. Viscoelastic Testing in An Obstetric Population at High-Risk of Hemorrhage. Am J Perinatol. 2022 Jan;39(2):154-160. doi: 10.1055/s-0040-1714397. PMID: 32791584.

No comparative study

Grottke O, Mallaiah S, Karkouti K, Saner F, Haas T. Fibrinogen Supplementation and Its Indications. Crit Care. 2020 Mar 24;24(1):110. doi: 10.1186/s13054-020-2799-5. PMID: 32204757.

Design: narrative review

Gultekin-Elbir EE, Pelletier JPR, Sylvester-Armstrong KR, Genc MR. Is thromboelastography reliable in postpartum coagulopathies? Two case reports and a literature review. J Clin Anesth. 2021 Dec;75:110489. doi: 10.1016/j.jclinane.2021.110489. PMID: 34537559.

Design: case report

Haas T, Görlinger K, Grassetto A, Agostini V, Simioni P, Nardi G, Ranucci M. Thromboelastometry for guiding bleeding management of the critically ill patient: a systematic review of the literature. Minerva Anestesiol. 2018 Sep;84(9):1090-1106. doi: 10.23736/S0375-9393.18.12484-2. PMID: 29667691.

Design: narrative review

Hartmann J, Hermelin D, Levy JH. Viscoelastic testing: an illustrated review of technology and clinical applications. Res Pract Thromb Haemost. 2022 Aug 25;6(6):e12793. doi: 10.1002/rth2.12793. PMID: 36051576.

Design: illustrated review

Hill JS, Devenie G, Powell M. Point-of-care testing of coagulation and fibrinolytic status during postpartum haemorrhage: Developing a thrombelastography-guided transfusion algorithm. Anaesth Intensive Care. 2011 Nov;39(6):1054-60. PMID: 22165358.

No comparative study (reference values)

Huissoud C, Carrabin N, Audibert F, Levrat A, Massignon D, Berland M, Rudigoz RC. Bedside assessment of fibrinogen level in postpartum haemorrhage by thrombelastometry. BJOG. 2009 Jul;116(8):1097-102. doi: 10.1111/j.1471-0528.2009.02187.x. PMID: 19438496.

Wrong comparison: women with PPH vs women withoug PPH

Hunt BJ, Allard S, Keeling D, Norfolk D, Stanworth SJ, Pendry K. A practical guideline for the haematological management of major haemorrhage. Br J Haematol. 2015 Jul;170(6):788-803. doi: 10.1111/bjh.13580. PMID: 26018837.

Management article

Jambor C, Kozek-Langenecker SA, Frietsch T, Knels R. Thrombelastography Should Be Included in the Algorithm for the Management of Postpartum Hemorrhage. Anesth Analg. 2010 Mar 1;110(3):1001. doi: 10.1213/ANE.0b013e3181c8b8e4. PMID: 20185674.

Design: letter to the editor

Karlsson O. Experience of Point-of-Care Devices in Obstetrical Care. Semin Thromb Hemost. 2017 Oct;43(7):683-689. doi: 10.1055/s-0037-1602657. PMID: 28750470.

Design: experience article

Karlsson O, Jeppsson A, Hellgren M. Major obstetric haemorrhage: Monitoring with thromboelastography, laboratory analyses or both? Int J Obstet Anesth. 2014 Feb;23(1):10-7. doi: 10.1016/j.ijoa.2013.07.003. PMID: 24321520.

Wrong comparison: women with PPH vs women without PPH

Karlsson O, Sporrong T, Hillarp A, Jeppsson A, Hellgren M. Prospective longitudinal study of thromboelastography and standard hemostatic laboratory tests in healthy women during normal pregnancy. Anesth Analg. 2012 Oct;115(4):890-8. doi: 10.1213/ANE.0b013e3182652a16. PMID: 22798531.

No comparison

Kaufner L, Henkelmann A, Von Heymann C, Feldheiser A, Mickley L, Niepraschk-Von Dollen K, Grittner U, Henrich W, Bamberg C. Can prepartum thromboelastometry-derived parameters and fibrinogen levels really predict postpartum hemorrhage? J Perinat Med. 2018 Feb 23;46(2):179-187. doi: 10.1515/jpm-2016-0361. PMID: 28493831.

Comparing women with and without PPH

Khanna P, Sinha C, Singh AK, Kumar A, Sarkar S. The role of point of care thromboelastography (TEG) and thromboelastometry (ROTEM) in management of Primary postpartum haemorrhage: A meta-analysis and systematic review. J Anaesthesiol Clin Pharmacol. 2021 Jul-Sep;37(3):317-328. doi: 10.4103/joacp.JOACP_347_19. PMID: 34759540.

exclude Want niet alle 5 zijn de RCT zijn geinclude.lage kwaliteit

Kroh S, Waters JH. Obstetrical Hemorrhage. Anesthesiol Clin. 2021 Jun;39(2):265-279. doi: 10.1016/j.anclin.2021.02.003. PMID: 34024431.

Management article

Kumaraswami S, Butwick A. Latest advances in postpartum hemorrhage management. Curr Opin Anaesthesiol. 2022 Jun 1;35(3):274-280. doi: 10.1097/ACO.0000000000001131. PMID: 35671052.

Design: narrative review

Levi M, Hunt BJ. A critical appraisal of point-of-care coagulation testing in critically ill patients. J Thromb Haemost. 2015 Nov;13(11):1960-7. doi: 10.1111/jth.13142. PMID: 26382995.

Design: narrative review

Li CQ, Wang DX, Wei XY. Perioperative management of pregnant women combined with congenital fibrinogen deficiency: four cases report and literature review. Chin Med J (Engl). 2015 Jan 20;128(2):275-8. doi: 10.4103/0366-6999.149236. PMID: 25591577.

Language: Chinese

Liew-Spilger AE, Sorg NR, Brenner TJ, Langford JH, Berquist M, Mark NM, Moore SH, Mark J, Baumgartner S, Abernathy MP. Utilization of point-of-care ultrasound and rotational thromboelastometry (ROTEM) in the diagnosis and management of amniotic fluid embolism presenting as post-partum hemorrhage and cardiac arrest. Am J Case Rep. 2022 Mar 10;23:e935469. doi: 10.12659/AJCR.935469. PMID: 35264581.

Design: narrative review

Mallaiah S, Barclay P, Harrod I, Chevannes C, Bhalla A. Introduction of an algorithm for ROTEM-guided fibrinogen concentrate administration in major obstetric haemorrhage. Anaesthesia. 2015 Feb;70(2):166-75. doi: 10.1111/anae.12859. PMID: 25388828.

Wrong intervention and control

Mao YJ, Yang ZJ. The use of thromboelastography for the peripartum management of a patient with platelet storage pool disorder. Int J Obstet Anesth. 2019 Feb;37:127-130. doi: 10.1016/j.ijoa.2018.10.007. PMID: 30420140.

Language: Chinese

Markley JC, Carusi DA. Clinical value of early viscoelastometric point-of-care testing during postpartum hemorrhage for the prediction of severity of bleeding: A multicenter prospective cohort study in the Netherlands. Am J Obstet Gynecol. 2022 Jan;226(1):S1-S11. doi: 10.1016/j.ajog.2021.06.077. PMID: 34998498.

Design: narrative review

Matkovic E, Lindholm PF. Trials and Tribulations of Viscoelastic-Based Determination of Fibrinogen Concentration. Clin Appl Thromb Hemost. 2022 Jan-Dec;28:10760296221121290. doi: 10.1177/10760296221121290. PMID: 36062470.

Design: narrative review

McNamara H, Mallaiah S. Postpartum Hemorrhage: What's New? Hematology Am Soc Hematol Educ Program. 2019 Dec 6;2019(1):539-547. doi: 10.1182/hematology.2019000061. PMID: 31808868.

Management article

McNamara H, Mallaiah S, Barclay P, Chevannes C, Bhalla A. Role of Viscoelastic and Conventional Coagulation Tests for Management of Blood Product Replacement in the Bleeding Patient. Transfus Med Rev. 2019 Oct;33(4):217-223. doi: 10.1016/j.tmrv.2019.09.001. PMID: 31611133.

Design: case report

Merrill J, Sultan P, Sharawi N. Managing coagulopathy following PPH. Best Pract Res Clin Obstet Gynaecol. 2019 Nov;61:106-120. doi: 10.1016/j.bpobgyn.2019.06.001. PMID: 31320209.

Design: narrative review/case report

Nakamura E, Matsunaga S, Kikuchi A, Takai Y. Coagulopathy and placental abruption: Changing management with ROTEM-guided fibrinogen concentrate therapy. J Obstet Gynaecol Res. 2019 Jan;45(1):38-43. doi: 10.1111/jog.13813. PMID: 30255501.

Wrong outcome measures

Nath SS, Pandey CK, Kumar S. Advances in anesthetic and obstetric management of patients with placenta accreta spectrum. Int J Obstet Anesth. 2021 May;46:102983. doi: 10.1016/j.ijoa.2021.102983. PMID: 33775682.

Design: narrative review

Nelson DB, Ogunkua O, Cunningham FG. Comparative retrospective study on the validity of point-of-care testing device for massive obstetrical hemorrhage: dry hematology vs thromboelastography. Am J Obstet Gynecol MFM. 2021 Nov;3(6):100475. doi: 10.1016/j.ajogmf.2021.100475. PMID: 34438047.

Design: narrative review

Ondondo BO. Clinical application of viscoelastic point-of-care tests of coagulation-shifting paradigms. Afr J Lab Med. 2021 Oct 29;10(1):1316. doi: 10.4102/ajlm.v10i1.1316. PMID: 34858792.

wrong comparison

Pérez-Calatayud ÁA, Briones-Garduño JC, Rojas-Arellano ML. Point-of-Care Viscoelastic Tests in the Management of Obstetric Hemorrhage. Rev Bras Ginecol Obstet. 2021 Aug;43(8):630-636. doi: 10.1055/s-0041-1735229. PMID: 34350988.

Language: Spanish

Pacheco LD, Saade GR, Hankins GDV. Medical management of postpartum hemorrhage: An update. Semin Perinatol. 2019 Feb;43(1):22-26. doi: 10.1053/j.semperi.2018.11.005. PMID: 30578145.

Management article

Perelman A, Limaye M, Blakemore J, Hoskins IA. Thromboelastography versus standard coagulation assays in patients with postpartum hemorrhage. J Matern Fetal Neonatal Med. 2017 Jan;30(1):39-43. doi: 10.3109/14767058.2015.1126244. PMID: 26626539.

No comparison

Phillips AN, Kirkland LL, Wagner WE, Melamed R, Tierney DM. Management of major obstetric haemorrhage using ROTEM point-of-care haemostasis analysers can reduce blood product usage without increasing fibrinogen replacement therapy. Blood Transfus. 2016 Nov;14(6):491-497. doi: 10.2450/2016.0303-15. PMID: 27483477.

Design: case report

Rajpal G, Pomerantz JM, Ragni MV, Waters JH, Vallejo MC. Use of thromboelastography and rotational thromboelastometry for the rational and opportune transfusion of hemoderivatives in obstetric hemorrhage. Transfus Apher Sci. 2017 Oct;56(5):728-732. doi: 10.1016/j.transci.2017.08.011. PMID: 28867136.

Design: case report

Ramler PI, Gillissen A, Henriquez DDCA, Caram-Deelder C, Markovski AA, de Maat MPM, Duvekot JJ, Eikenboom JCJ, Bloemenkamp KWM, van Lith JMM, van den Akker T, van der Bom JG. Clinical value of early assessment of hyperfibrinolysis by rotational thromboelastometry during postpartum hemorrhage for the prediction of severity of bleeding: A multicenter prospective cohort study in the Netherlands. J Thromb Haemost. 2022 Jan;20(1):38-48. doi: 10.1111/jth.15538. PMID: 34608767.

No comparison between TEG/ROTEM tests and standard lab tests

Ranucci M, Di Dedda U, Baryshnikova E. Use of earlier-reported rotational thromboelastometry parameters to evaluate clotting status, fibrinogen, and platelet activities in postpartum hemorrhage compared to surgery and intensive care patients. Thromb Res. 2019 May;177:103-111. doi: 10.1016/j.thromres.2019.03.001. PMID: 30870622.

Design: narrative review

Rigouzzo A, Louvet N, Favier R, Ore MV, Piana F, Girault L, Farrugia M, Sabourdin N, Constant I. Effects of rotational thromboelastometry-guided transfusion management in patients undergoing surgical intervention for postpartum hemorrhage: An observational study. Int J Obstet Anesth. 2021 May;46:102983. doi: 10.1016/j.ijoa.2021.102983. PMID: 33775682.

No comparative study

Roberts TCD, De Lloyd L, Bell SF, Cohen L, James D, Ridgway A, Jenkins V, Field V, Collis RE, Collins PW. The role of viscoelastic testing in the management of the parturient. Int J Obstet Anesth. 2022 Aug;51:103549. doi: 10.1016/j.ijoa.2022.103549. PMID: 35752594.

No comparative study

Roullet S, de Maistre E, Ickx B, Blais N, Susen S, Faraoni D, Garrigue D, Bonhomme F, Godier A, Lasne D. Position of the French Working Group on Perioperative Haemostasis (GIHP) on viscoelastic tests: What role for which indication in bleeding situations? Anaesth Crit Care Pain Med. 2020 Oct;39(5):631-635. doi: 10.1016/j.accpm.2020.07.009. PMID: 32745697.

Design: narrative review

Roullet S, de Maistre E, Ickx B, Blais N, Susen S, Faraoni D, Garrigue D, Bonhomme F, Godier A, Lasne D, Albaladejo P, Belisle S, Blais N, Bonhomme F, Borel-Derlon A, Borg JY, Bosson JL, Cohen A, Collet JP, de Maistre E, Faraoni D, Fontana P, Garrigue Huet D, Godier A, Gruel Y, Guay J, Hardy JF, Huet Y, Ickx B, Laporte S, Lasne D, Levy JH, Llau J, Le Gal G, Lecompte T, Lessire S, Longrois D, Madi-Jebara S, Marret E, Mas JL, Mazighi M, Mismetti P, Morange PE, Motte S, Mullier F, Nathan N, Nguyen P, Ozier Y, Pernod G, Rosencher N, Roullet S, Roy PM, Samama CM, Schlumberger S, Schved JF, Sié P, Steib A, Susen S, van Belle E, Van der Linden P, Vincentelli A, Zufferey P. Position of the French Working Group on Perioperative Haemostasis (GIHP) on viscoelastic tests: What role for which indication in bleeding situations? Anaesth Crit Care Pain Med. 2020 Oct;39(5):631-635. doi: 10.1016/j.accpm.2020.07.009. PMID: 32745697.

Design: narrative review

Schöchl H, Solomon C, Voelckel W. Thromboelastometry in the perioperative setting. Anaesthesia. 2012 Jan;67 Suppl 1:72-7. doi: 10.1111/j.1365-2044.2011.06960.x. PMID: 22167408.

No comparative study

Schol PBB, Lange ND, Henskens Y, Smits LJM, Smeets NAC, Scheepers HCJ. Restrictive versus liberal fluid administration strategy (REFILL study) in postpartum hemorrhage and its effects on thromboelastometry (ROTEM) values: a randomized, controlled trial. BMC Pregnancy Childbirth. 2021 Jun 5;21(1):416. doi: 10.1186/s12884-021-03886-3. PMID: 34090378.

Wrong I, C and P

Sharp G, Young CJ. Point-of-care viscoelastic assay devices (rotational thromboelastometry and thromboelastography): a primer for surgeons. ANZ J Surg. 2021 May;91(5):841-846. doi: 10.1111/ans.16788. PMID: 34031989.

Wrong P: surgically bleeding patients

Shin HJ, Nam SW, Koo BW, Kim J, Hwang JW, Do SH, Na HS. Rotational thromboelastometry during Cesarean section as a predictive evaluation for the progression of persistent postpartum hemorrhage in parturients with placenta previa: A prospective observational study. J Clin Med. 2021 Dec 14;10(24):5869. doi: 10.3390/jcm10245869. PMID: 34945164.

Wrong comparison: PPH vs. No-PPH. Wrong population (?)

Shreeve NE, Barry JA, Deutsch LR, Gomez K, Kadir RA. Changes of Coagulation and Fibrinolytic Status Detected by Thromboelastography (TEG6s R) in Pregnancy, Labor, Early Postpartum, Postpartum Hemorrhage and Heparin Treatment for Perinatal Venous Thrombosis. J Clin Med. 2022 Jan 28;11(3):693. doi: 10.3390/jcm11030693. PMID: 35160157.

Wrong comparison, wrong outcome measures

Snegovskikh D, Walton Z, Souzdalnitski D. Functional fibrinogen (FLEV-TEG) versus the Clauss method in an obstetric population: A comparative study. Int J Obstet Anesth. 2019 Feb;37:127-130. doi: 10.1016/j.ijoa.2018.10.007. PMID: 30420140.

Design: narrative review

Solomon C, Collis RE, Collins PW. Haemostatic monitoring during postpartum haemorrhage and implications for management. Br J Anaesth. 2015 Dec;115 Suppl 2:ii85-ii92. doi: 10.1093/bja/aev372. PMID: 26658206.

Design: narrative review

Spahn DR, Spahn GH, Stein P. Indications and Risks of Fibrinogen in Surgery and Trauma. Semin Thromb Hemost. 2016 Mar;42(2):147-54. doi: 10.1055/s-0035-1564835. PMID: 26838697.

Wrong population, wrong design (narrative)

Spasiano A, Matellon C, Orso D, Brussa A, Cafagna M, Marangone A, Dogareschi T, Bove T, Giacomello R, Fontana D, Vetrugno L, Della Rocca G. Changes in thromboelastography parameters in pregnancy, labor, and the immediate postpartum period. Int J Lab Hematol. 2021 Aug;43(4):772-780. doi: 10.1111/ijlh.13445. PMID: 33522624.

Wrong outcome measures

Suemitsu C, Fudaba M, Kitada K, Kurihara Y, Tahara M, Hamuro A, Misugi T, Nakano A, Koyama M, Tachibana D. Significance of thromboelastography in the monitoring of maternal coagulation disorders in preeclampsia. J Obstet Gynaecol Res. 2022 Jan;48(1):59-65. doi: 10.1111/jog.15062. PMID: 34672098.

Wrong outcome measures

Tahitu M, Ramler PI, Gillissen A, Caram-Deelder C, Henriquez DDCA, de Maat MPM, Duvekot JJ, Eikenboom J, Bloemenkamp KWM, van den Akker T, van der Bom JG. Assessment of Coagulation by Thromboelastography During Ongoing Postpartum Hemorrhage: A Retrospective Cohort Analysis. J Clin Med. 2022 Feb 15;11(4):1001. doi: 10.3390/jcm11041001. PMID: 35207289.

No comparative study

Toffaletti JG, Buckner KA. Point-of-Care Thromboelastometry in the Management of Acute Obstetric Hemorrhage. J Appl Lab Med. 2019 Jan;3(4):684-695. doi: 10.1373/jalm.2018.026476. PMID: 31639736.

Wrong population, wrong outcome

Tsang Y, Kurniawan AR, Tomasek O, Hessian E, Bramley D, Daly O, Simons K, Imberger G. Evaluating the Association Between Fibrinogen and Rotational Thromboelastometry and the Progression to Severe Obstetric Hemorrhage. Anesth Analg. 2022 May 1;134(5):1001-1010. doi: 10.1213/ANE.0000000000005909. PMID: 35180166.

Wrong intervention

Waters JH. Thromboelastography predicts risks of obstetric complication occurrence in (hypo)dysfibrinogenemia patients under non-pregnant state. Thromb Res. 2015 Oct;136(4):783-5. doi: 10.1016/j.thromres.2015.08.010. PMID: 26319301.

Management article/narrative review

Whiting P, Al M, Westwood M, Ramos IC, Ryder S, Armstrong N, Misso K, Ross J, Severens J, Kleijnen J. Viscoelastic point-of-care testing to assist with the diagnosis, management and monitoring of haemostasis: A systematic review and cost-effectiveness analysis. Health Technol Assess. 2015 Jul;19(58):1-228. doi:10.3310/hta19580. PMID: 26215747; PMCID: PMC4781169.

Only 2 prediction studies on PPH included. Those studies do not match our PICO

Yurashevich M, Rosser M, Small M, Grotegut C, Kota N, Toffaletti J, Allen T. Evaluating the Association Between Fibrinogen and Rotational Thromboelastometry and the Progression to Severe Obstetric Hemorrhage. Clin Appl Thromb Hemost. 2023 Jan-Dec;29:10760296231175089. doi: 10.1177/10760296231175089. PMID: 37186763; PMCID: PMC10192949.

No comparative study

Zhou J, Xin Y, Ding Q, Jiang L, Chen Y, Dai J, Lu Y, Wu X, Liang Q, Wang H, Wang X. Thromboelastography predicts risks of obstetric complication occurrence in (hypo)dysfibrinogenemia patients under non-pregnant state. Clin Exp Pharmacol Physiol. 2016 Feb;43(2):149-56. doi: 10.1111/1440-1681.12509. PMID: 26510121.

Wrong P

Zhu X, Tang J, Huang X, Zhou Y. Diagnostic value of fibrinogen combined with thromboelastogram in postpartum hemorrhage after vaginal delivery. Am J Transl Res. 2022 Mar 15;14(3):1877-1883. PMID: 35422901; PMCID: PMC8991141.

Wrong comparison: women with PPH vs women without PPH

Mallaiah S, Barclay P, Harrod I, Chevannes C, Bhalla A. Introduction of an algorithm for ROTEM-guided fibrinogen concentrate administration in major obstetric haemorrhage. Anaesthesia. 2015 Feb;70(2):166-75. doi: 10.1111/anae.12859. Epub 2014 Oct 7. Erratum in: Anaesthesia. 2015 Nov;70(11):1334. doi: 10.1111/anae.13271. PMID: 25289791.

Correction

Fan G, Yuan M, Niu H, Lu Y, Yang H, Liang X. The Significance of Thromboelastogram in Predicting Postpartum Hemorrhage and Guiding Blood Transfusion. Clin Lab. 2022 Feb 1;68(2). doi: 10.7754/Clin.Lab.2021.210317. Retraction in: Clin Lab. 2023 Feb 1;69(2). doi: 10.7754/Clin.Lab.2021.210399. PMID: 35142183.

Retracted paper

Beoordelingsdatum en geldigheid

Publicatiedatum  : 12-12-2025

Beoordeeld op geldigheid  : 12-12-2025

Initiatief en autorisatie

Initiatief:
  • Nederlandse Vereniging voor Obstetrie en Gynaecologie
Geautoriseerd door:
  • Nederlandse Internisten Vereniging
  • Nederlandse Vereniging voor Anesthesiologie
  • Nederlandse Vereniging voor Obstetrie en Gynaecologie
  • Nederlandse Vereniging voor Klinische Chemie en Laboratoriumgeneeskunde
  • Patiëntenfederatie Nederland

Algemene gegevens

De ontwikkeling/herziening van deze richtlijnmodule werd ondersteund door het Kennisinstituut van de Federatie Medisch Specialisten (www.demedischspecialist.nl/kennisinstituut) en werd gefinancierd door de Stichting Kwaliteitsgelden Medisch Specialisten (SKMS). De financier heeft geen enkele invloed gehad op de inhoud van de richtlijnmodule.

Samenstelling werkgroep

Voor het ontwikkelen van de richtlijnmodule is in 2022 een multidisciplinaire werkgroep ingesteld, bestaande uit vertegenwoordigers van alle relevante specialismen (zie hiervoor de Samenstelling van de werkgroep) die betrokken zijn bij de zorg voor patiënten met haemorrhagia postpartum.

 

Werkgroep 

  • Dr. M.(Martina) Porath (voorzitter) (NVOG)
  • Dr. H.C.J. (Liesbeth) Scheepers (NVOG)
  • Dr. D.D.C.A. (Dacia) Henriquez (NVOG)
  • Dr. J.M. (Annemieke) Middeldorp(NVOG)
  • Prof. dr. T.H. (Thomas) van den Akker (NVOG)
  • Dr. P. (Paul) Ramler (NVOG) (tot September 2023)
  • Dr. K.P.M. (Karin) van Galen(NIV)
  • Drs. H.W. (Hannah) de Klerk (KNOV)
  • Drs. L. (Lianne) Zondag (KNOV)
  • Prof. dr. ir. Y.M.C. (Yvonne) Henskens (NVKC)
  • Dr. I.C.M. (Ingrid) Beenakkers (NVA)
  • Dr. S. (Simone) Willems (NVA)
  • Mw. I. (Ilse) van Ee (PFN)

Klankboardgroep

  • Drs. K. (Klaartje) Caminada (AZN)
  • Mw. B. (Britt) Ketelaars (PFN)

Met ondersteuning van

  • Dr. M. (Mohammadreza) Abdollahi, adviseur, Kennisinstituut van de Federatie van Medisch Specialisten
  • Dr. I.M. (Irina) Mostovaya, senior adviseur, Kennisinstituut van de Federatie van Medisch Specialisten
  • Dr. J. (Jana) Tuijtelaars, adviseur, Kennisinstituut van de Federatie van Medisch Specialisten
  • Drs. D.A.M. (Danique) Middelhuis, adviseur, Kennisinstituut van de Federatie van Medisch Specialisten
  • Dr. M. (Majke) van Bommel, adviseur, Kennisinstituut van de Federatie van Medisch Specialisten
  • Dr. L. (Leanne) Küpers, adviseur, Kennisinstituut van de Federatie van Medisch Specialisten
  • Drs. D.A.M. (Fieke) Pepping, junior adviseur, Kennisinstituut van de Federatie van Medisch Specialisten
  • Linda Niesink, medisch informatie specialist, Kennisinstituut van de Federatie Medisch Specialisten
  • Laura Boerboom, medisch informatie specialist, Kennisinstituut van de Federatie Medisch Specialisten
  • Alies Oost, medisch informatie specialist, Kennisinstituut van de Federatie Medisch Specialisten

Belangenverklaringen

Een overzicht van de belangen van werkgroepleden en het oordeel over het omgaan met eventuele belangen vindt u in onderstaande tabel. De ondertekende belangenverklaringen zijn op te vragen bij het secretariaat van het Kennisinstituut van de Federatie Medisch Specialisten via secretariaat@kennisinstituut.nl.

Naam

Hoofdfunctie

Nevenwerkzaamheden

Persoonlijke financiële belangen

Persoonlijke relaties

Extern gefinancierd onderzoek

Intellectuele belangen en reputatie

Overige belangen

Datum

Restrictie

Martina Porath

gynaecoloog-perinatoloog

Maxima Medisch Centrum

Voorzitter focusgroep Acute Verloskunde Noord-Brabant

Lid NVOG werkgroep Otterlo

geen

geen

geen

geen

geen

04/28/2025

 

Liesbeth Scheepers

perinatoloog MUMC

Richtlijnen commissie Otterloo groep

Voorzitter Regioconsortium Geboortezorg Limburg

Vice voorzitter Perinatale audit Limburg

Geen

Nee

ZONMW onderzoek, niet op dit onderwerp

Nee

Nee

04/25/2025

 

Annemieke Middeldorp

Gynaecoloog Perinatoloog

Leids Universitair Medisch Centrum, gestopt met werken vanaf 2024

geen

geen

geen

geen

geen

geen

04/25/2025

 

Dacia Henriquez

Gynaecoloog, Perinatoloog, Amphia Ziekenhuis

Geen

Geen

Geen

Geen

Geen

Geen

04/28/2025

 

Thomas van den Akker

Gynaecoloog perinatoloog, LUMC, hoogleraar Verloskunde

Hoogleraar VU

*Global Maternal Health, Athena Instituut.

*Perined bestuurslid

*RvT Wemos.

*FMG Pijlervoorzitter NVOG

*Vz working party for international safe motherhood and reproductive health.

*Perinatale audit regiovoorzitter.

Alles onbetaald.

Geen

Geen

Geen

Door werk van de commissie komt het werk van mijn voormalig promovendi Ada Gillissen en Paul Ramler meer in de aandacht staan, omdat sommige aanbevelingen hierop gebaseerd zijn (met name van laatstgenoemde ten aanzien van ballon versus embolisatie).

 

Het feit dat ik als bijdrager op de richtlijn sta kan gezien worden als ten goede komend aan de boegbeeldfunctie die ik bij de NVOG heb, maar het effect hiervan lijkt beperkt in het licht van mijn andere activiteiten. 

Geen

04/25/2025

 

Paul Ramler

(tot September 2023)

AIOS Gynaecologie, cluster Leiden

Geen

Geen

Geen

Geen

Geen

Geen

29/01/2023

 

Ingrid Beenakkers

Anesthesioloog, UMCU/WKZ

geen

geen

geen

geen

geen

geen

04/28/2025

 

Simone Anna Alexandra Sijm-Willems

Anesthesioloog Radboudumc

-

-zs

-

-

-

-

04/25/2025

 

Karin van Galen

internist-hematoloog UMC Utrecht

geen

geen

n.v.t.

Octapharma: Pregnancy and inherited bleeding disorders - unresticted research grant, projectleider.

Voorzitter Nederlands Zorgnetwerk Vrouwen met een stollingsstoornis.

Tot Febr 2025 voorzitter Women and Girls with beleeding Disorders Group European Assosiation for Heamophilia and Alied Disorders - momenteel nog actief lid van deze werkgroep.

n.v.t.

04/25/2025

 

Yvonne Henskens

Klinisch chemicus, waarnemend hoofd Centraal Diagnostisch Laboratorium

Hoogleraar Klinische Chemie ihb Hemostase

Voorzitter Vereniging Hematologisch Laboratoria 2020-heden

Lid Vici beoordelingscie 2022

Lid raad van Advies NVKC 2023-heden

Adviseur Promicol 2020-heden

geen

geen

Voor alle studies in het kader van mijn leerstoel worden reagentia of apparatuur gratis of met korting verkregen, hierbij wordt geen enkele IVD methode of bedrijf uitgesloten mits het past in het doel van mijn leerstoel.

Noyons stipendium NVKC (prijs)

Stago / Validatie van apparatuur en/of reagentia / Ja

Siemens / Validatie van apparatuur en/of reagentia / Ja

Werfen / Validatie van apparatuur en/of reagentia / N

Nodia / Validatie van apparatuur en/of reagentia / Nee

Promicol / Validatie van apparatuur en/of reagentia / Nee

nee

nee

04/25/2025

 

Hannah de Klerk

Zelfstandig eerstelijns verloskundige (ZZP), betaald

PhD aanstelling Amsterdam UMC, locatie VUMc, onbetaald

Gastdocent HU, betaald

Projectleider KNOV, betaald

geen

nee

nee

nee

nee

7/10/2022

 

Lianne Zondag

Eerstelijns verloskundige - verloskundige praktijk de Toekomst - Geldermalsen

KNOV - senior richtlijnonwikkelaar

Bestuurslid Netwerk Geboortezorg Rivierenland

PhD candidate Maastricht University

Geen

Geen

Geen

Geen

Geen

2/6/2023

 

Ilse van Ee

Adviseur Patientenbelang - full time

inbreng patientenperspectief

Ervaringsdeskundige patientvertegenwoordiger - Eupati - fellow Psoriasispatienten Nederland - onbetaald

Coordinator Patientenpraticipatie, lid centrale redactie Psoriasispatienten Nederland - onbetaald

Eupati mentor - Eupati Nl - onbetaald

nee

nvt

Janssen / Freedom of disease Psoriasis / ja

nee

nvt

04/25/2025

 

Klaartje Caminada

Medisch Manager Ambulancezorg, lid protocollencommissie Ambulancezorg Nederland

geen

geen

geen

geen

geen

geen

04/29/2025

 

Brit Ketelaars

Adviseur patiëntbelang bij Patiëntenfederatie Nederland (full time, betaald)

geen

geen

geen

geen

geen

geen

04/25/2025

 

Inbreng patiëntenperspectief

De werkgroep besteedde aandacht aan het patiëntenperspectief door uitnodigen van Patiëntenfederatie  Nederland, Geboortebeweging en Het Buikencollectiefvoor de invitational conference. Het verslag hiervan is besproken in de werkgroep. De verkregen input is meegenomen bij het opstellen van de uitgangsvragen, de keuze voor de uitkomstmaten en bij het opstellen van de overwegingen. De conceptrichtlijn is tevens voor commentaar voorgelegd aan Patiëntenfederatie Nederland en de eventueel aangeleverde commentaren zijn bekeken en verwerkt.

 

Kwalitatieve raming van mogelijke financiële gevolgen in het kader van de Wkkgz

Bij de richtlijnmodule voerde de werkgroep conform de Wet kwaliteit, klachten en geschillen zorg (Wkkgz) een kwalitatieve raming uit om te beoordelen of de aanbevelingen mogelijk leiden tot substantiële financiële gevolgen. Bij het uitvoeren van deze beoordeling is de richtlijnmodule op verschillende domeinen getoetst (zie het stroomschema bij Werkwijze).

 

Uit de kwalitatieve raming blijkt dat er waarschijnlijk mogelijk substantiële financiële gevolgen zijn, zie onderstaande tabel.

 

In Nederland bevallen per jaar ca. 160.000 vrouwen. De incidentie van haemorrhagia postpartum  is 7 tot 10%. Dit zijn 11.200 tot 16.000 vrouwen per jaar. Het aantal vrouwen met risicofactoren voor HPP is niet bekend.

Module

Uitkomst raming

Toelichting

Stollingscorrectie bij HPP

geen financiële gevolgen

De aanbeveling betreft alleen een deel van de vrouwen met HPP. Er wordt aanbevolen om TEG/ROTEM te gebruiken, indien deze methode al beschikbaar is in het ziekenhuis. Er zijn geen implementatiekosten te verwachten.

Werkwijze

Voor meer details over de gebruikte richtlijnmethodologie verwijzen wij u naar de Werkwijze. Relevante informatie voor de ontwikkeling/herziening van deze richtlijnmodule is hieronder weergegeven.

Zoekverantwoording

Algemene informatie

Richtlijn:  Richtlijn Modulaire actualisatie richtlijn Hemorrhagia Postpartum (HPP)

Uitgangsvraag: Wat is het effect van stollingscorrectie op basis van trombo-elastografie (TEG/ ROTEM) vergeleken met stollingscorrectie op basis van standaard laboratoriumtests bij HPP?

Database(s): Medline (OVID), Embase

Datum: 16-11-2023

Periode: > 2000

Talen: geen beperking

Literatuurspecialist: Linda Niesink

BMI zoekblokken: voor verschillende opdrachten wordt (deels) gebruik gemaakt van de zoekblokken van BMI-Online https://blocks.bmi-online.nl/ Bij gebruikmaking van een volledig zoekblok zal naar de betreffende link op de website worden verwezen.

Toelichting en opmerkingen:

 

→ Voor deze vraag is gezocht op de elementen HPP (in het blauw) en trombo-elastografie (in het groen).

 

→ De genoemde sleutelpublicaties van Collins (2017;1), Collins (2017;2), Mallaiah (2015) en Amgalan (2020) zitten allen in de zoekopbrengst.

 

→ Eventueel zijn er nog 133 overige studiedesigns beschikbaar.

 

→ Resultaten staan in Rayyan: https://rayyan.ai/reviews/846567.

Te gebruiken voor richtlijnen tekst:

In de databases Embase (via embase.com) en Medline (via OVID) is op 16-11-2023 met relevante zoektermen gezocht naar systematische reviews, RCT’s en observationele studies over trombo-elastografie bij vrouwen met aanhoudend bloedverlies postpartum. De literatuurzoekactie leverde 250 unieke treffers op.

Zoekopbrengst

 

EMBASE

OVID/MEDLINE

Ontdubbeld

SR’s

21

12

21

RCT’s

49

25

51

Observationele studies

40

35

45

Overige studies

121

80

133

Totaal

110 (230)

72 (152)

117 (250)

Zoekstrategie

Embase & Ovid/Medline

Database

Zoektermen

Embase

 

 

No.

Query

Results

#1

'postpartum hemorrhage'/exp OR 'fluxus postpartum':ti,ab,kw OR 'postpartum hemorrhage':ti,ab,kw OR 'post partum haemorrhage':ti,ab,kw OR 'post partum hemorrhage':ti,ab,kw OR 'postpartal haemorrhage':ti,ab,kw OR 'postpartal hemorrhage':ti,ab,kw OR 'postpartum bleeding':ti,ab,kw OR 'postpartum haemorrhage':ti,ab,kw OR 'puerperal haemorrhage':ti,ab,kw OR 'puerperal hemorrhage':ti,ab,kw OR (('blood loss' NEAR/6 (postpartum OR 'post partum' OR delivery OR cesarean)):ti,ab,kw) OR 'obstetric* bleeding':ti,ab,kw OR 'obstetric* hemorrhage':ti,ab,kw OR 'obstetric* haemorrhage':ti,ab,kw

24,969

#2

'thromboelastography'/exp OR 'thromboelastometry'/exp OR 'viscoelastic test'/exp OR 'viscoelastic testing'/exp OR teg:ti,ab,kw OR rotem:ti,ab,kw OR thromboelastograph*:ti,ab,kw OR thrombelastogram:ti,ab,kw OR thrombelastograph*:ti,ab,kw OR 'thrombo elastograph*':ti,ab,kw OR 'thromboelastogram':ti,ab,kw OR thromboelastometr*:ti,ab,kw OR thrombelastometr*:ti,ab,kw OR 'viscoelastic test*':ti,ab,kw OR viscoelastometr*:ti,ab,kw

17,605

#3

#1 AND #2 AND [2000-2024]/py NOT (('animal'/exp OR 'animal experiment'/exp OR 'animal model'/exp OR 'nonhuman'/exp) NOT 'human'/exp) NOT ('conference abstract'/it OR 'conference review'/it OR 'editorial'/it OR 'letter'/it OR 'note'/it)

231

#4

'meta analysis'/exp OR 'meta analysis (topic)'/exp OR metaanaly*:ti,ab OR 'meta analy*':ti,ab OR metanaly*:ti,ab OR 'systematic review'/de OR 'cochrane database of systematic reviews'/jt OR prisma:ti,ab OR prospero:ti,ab OR (((systemati* OR scoping OR umbrella OR 'structured literature') NEAR/3 (review* OR overview*)):ti,ab) OR ((systemic* NEAR/1 review*):ti,ab) OR (((systemati* OR literature OR database* OR 'data base*') NEAR/10 search*):ti,ab) OR (((structured OR comprehensive* OR systemic*) NEAR/3 search*):ti,ab) OR (((literature NEAR/3 review*):ti,ab) AND (search*:ti,ab OR database*:ti,ab OR 'data base*':ti,ab)) OR (('data extraction':ti,ab OR 'data source*':ti,ab) AND 'study selection':ti,ab) OR ('search strategy':ti,ab AND 'selection criteria':ti,ab) OR ('data source*':ti,ab AND 'data synthesis':ti,ab) OR medline:ab OR pubmed:ab OR embase:ab OR cochrane:ab OR (((critical OR rapid) NEAR/2 (review* OR overview* OR synthes*)):ti) OR ((((critical* OR rapid*) NEAR/3 (review* OR overview* OR synthes*)):ab) AND (search*:ab OR database*:ab OR 'data base*':ab)) OR metasynthes*:ti,ab OR 'meta synthes*':ti,ab

978,169

#5

'clinical trial'/exp OR 'randomization'/exp OR 'single blind procedure'/exp OR 'double blind procedure'/exp OR 'crossover procedure'/exp OR 'placebo'/exp OR 'prospective study'/exp OR rct:ab,ti OR random*:ab,ti OR 'single blind':ab,ti OR 'randomised controlled trial':ab,ti OR 'randomized controlled trial'/exp OR placebo*:ab,ti

3,913,335

#6

'case control study'/de OR 'comparative study'/exp OR 'control group'/de OR 'controlled study'/de OR 'controlled clinical trial'/de OR 'crossover procedure'/de OR 'double blind procedure'/de OR 'phase 2 clinical trial'/de OR 'phase 3 clinical trial'/de OR 'phase 4 clinical trial'/de OR 'pretest posttest design'/de OR 'pretest posttest control group design'/de OR 'quasi experimental study'/de OR 'single blind procedure'/de OR 'triple blind procedure'/de OR (((control OR controlled) NEAR/6 trial):ti,ab,kw) OR (((control OR controlled) NEAR/6 (study OR studies)):ti,ab,kw) OR (((control OR controlled) NEAR/1 active):ti,ab,kw) OR 'open label*':ti,ab,kw OR (((double OR two OR three OR multi OR trial) NEAR/1 (arm OR arms)):ti,ab,kw) OR ((allocat* NEAR/10 (arm OR arms)):ti,ab,kw) OR placebo*:ti,ab,kw OR 'sham-control*':ti,ab,kw OR (((single OR double OR triple OR assessor) NEAR/1 (blind* OR masked)):ti,ab,kw) OR nonrandom*:ti,ab,kw OR 'non-random*':ti,ab,kw OR 'quasi-experiment*':ti,ab,kw OR crossover:ti,ab,kw OR 'cross over':ti,ab,kw OR 'parallel group*':ti,ab,kw OR 'factorial trial':ti,ab,kw OR ((phase NEAR/5 (study OR trial)):ti,ab,kw) OR ((case* NEAR/6 (matched OR control*)):ti,ab,kw) OR ((match* NEAR/6 (pair OR pairs OR cohort* OR control* OR group* OR healthy OR age OR sex OR gender OR patient* OR subject* OR participant*)):ti,ab,kw) OR ((propensity NEAR/6 (scor* OR match*)):ti,ab,kw) OR versus:ti OR vs:ti OR compar*:ti OR ((compar* NEAR/1 study):ti,ab,kw) OR (('major clinical study'/de OR 'clinical study'/de OR 'cohort analysis'/de OR 'observational study'/de OR 'cross-sectional study'/de OR 'multicenter study'/de OR 'correlational study'/de OR 'follow up'/de OR cohort*:ti,ab,kw OR 'follow up':ti,ab,kw OR followup:ti,ab,kw OR longitudinal*:ti,ab,kw OR prospective*:ti,ab,kw OR retrospective*:ti,ab,kw OR observational*:ti,ab,kw OR 'cross sectional*':ti,ab,kw OR cross?ectional*:ti,ab,kw OR multicent*:ti,ab,kw OR 'multi-cent*':ti,ab,kw OR consecutive*:ti,ab,kw) AND (group:ti,ab,kw OR groups:ti,ab,kw OR subgroup*:ti,ab,kw OR versus:ti,ab,kw OR vs:ti,ab,kw OR compar*:ti,ab,kw OR 'odds ratio*':ab OR 'relative odds':ab OR 'risk ratio*':ab OR 'relative risk*':ab OR 'rate ratio':ab OR aor:ab OR arr:ab OR rrr:ab OR ((('or' OR 'rr') NEAR/6 ci):ab)))

14,572,057

#7

#3 AND #4 - SR’s

21

#8

#3 AND #5 NOT #7 - RCT’s

49

#9

#3 AND #6 NOT #7 NOT #8 - observationele studies

40

#10

#7 OR #8 OR #9

110

#11

#3 NOT #10 – overige studiedesigns

121

 

Medline (OVID)

 

1  exp Postpartum Hemorrhage/ or 'fluxus postpartum'.ti,ab,kf. or 'postpartum hemorrhage'.ti,ab,kf. or 'post partum haemorrhage'.ti,ab,kf. or 'post partum hemorrhage'.ti,ab,kf. or 'postpartal haemorrhage'.ti,ab,kf. or 'postpartal hemorrhage'.ti,ab,kf. or 'postpartum bleeding'.ti,ab,kf. or 'postpartum haemorrhage'.ti,ab,kf. or 'puerperal haemorrhage'.ti,ab,kf. or 'puerperal hemorrhage'.ti,ab,kf. or ('blood loss' adj6 (postpartum or 'post partum' or delivery or cesarean)).ti,ab,kf. or 'obstetric* bleeding'.ti,ab,kf. or 'obstetric* hemorrhage'.ti,ab,kf. or 'obstetric* haemorrhage'.ti,ab,kf. (14272)
2   exp Thrombelastography/ or teg.ti,ab,kf. or rotem.ti,ab,kf. or thromboelastograph*.ti,ab,kf. or thrombelastogram.ti,ab,kf. or thrombelastograph*.ti,ab,kf. or 'thrombo elastograph*'.ti,ab,kf. or 'thromboelastogram'.ti,ab,kf. or thromboelastometr*.ti,ab,kf. or thrombelastometr*.ti,ab,kf. or 'viscoelastic test*'.ti,ab,kf. or viscoelastometr*.ti,ab,kf. (9916)
3  1 and 2 (181)
4  limit 3 to yr="2000 -Current" (174)
5  4 not (comment/ or editorial/ or letter/ or ((exp animals/ or exp models, animal/) not humans/)) (152)
6  meta-analysis/ or meta-analysis as topic/ or (metaanaly* or meta-analy* or metanaly*).ti,ab,kf. or systematic review/ or cochrane.jw. or (prisma or prospero).ti,ab,kf. or ((systemati* or scoping or umbrella or "structured literature") adj3 (review* or overview*)).ti,ab,kf. or (systemic* adj1 review*).ti,ab,kf. or ((systemati* or literature or database* or data-base*) adj10 search*).ti,ab,kf. or ((structured or comprehensive* or systemic*) adj3 search*).ti,ab,kf. or ((literature adj3 review*) and (search* or database* or data-base*)).ti,ab,kf. or (("data extraction" or "data source*") and "study selection").ti,ab,kf. or ("search strategy" and "selection criteria").ti,ab,kf. or ("data source*" and "data synthesis").ti,ab,kf. or (medline or pubmed or embase or cochrane).ab. or ((critical or rapid) adj2 (review* or overview* or synthes*)).ti. or (((critical* or rapid*) adj3 (review* or overview* or synthes*)) and (search* or database* or data-base*)).ab. or (metasynthes* or meta-synthes*).ti,ab,kf. (707005)
7  exp clinical trial/ or randomized controlled trial/ or exp clinical trials as topic/ or randomized controlled trials as topic/ or Random Allocation/ or Double-Blind Method/ or Single-Blind Method/ or (clinical trial, phase i or clinical trial, phase ii or clinical trial, phase iii or clinical trial, phase iv or controlled clinical trial or randomized controlled trial or multicenter study or clinical trial).pt. or random*.ti,ab. or (clinic* adj trial*).tw. or ((singl* or doubl* or treb* or tripl*) adj (blind$3 or mask$3)).tw. or Placebos/ or placebo*.tw. (2654886)
8  Case-control Studies/ or clinical trial, phase ii/ or clinical trial, phase iii/ or clinical trial, phase iv/ or comparative study/ or control groups/ or controlled before-after studies/ or controlled clinical trial/ or double-blind method/ or historically controlled study/ or matched-pair analysis/ or single-blind method/ or (((control or controlled) adj6 (study or studies or trial)) or (compar* adj (study or studies)) or ((control or controlled) adj1 active) or "open label*" or ((double or two or three or multi or trial) adj (arm or arms)) or (allocat* adj10 (arm or arms)) or placebo* or "sham-control*" or ((single or double or triple or assessor) adj1 (blind* or masked)) or nonrandom* or "non-random*" or "quasi-experiment*" or "parallel group*" or "factorial trial" or "pretest posttest" or (phase adj5 (study or trial)) or (case* adj6 (matched or control*)) or (match* adj6 (pair or pairs or cohort* or control* or group* or healthy or age or sex or gender or patient* or subject* or participant*)) or (propensity adj6 (scor* or match*))).ti,ab,kf. or (confounding adj6 adjust*).ti,ab. or (versus or vs or compar*).ti. or ((exp cohort studies/ or epidemiologic studies/ or multicenter study/ or observational study/ or seroepidemiologic studies/ or (cohort* or 'follow up' or followup or longitudinal* or prospective* or retrospective* or observational* or multicent* or 'multi-cent*' or consecutive*).ti,ab,kf.) and ((group or groups or subgroup* or versus or vs or compar*).ti,ab,kf. or ('odds ratio*' or 'relative odds' or 'risk ratio*' or 'relative risk*' or aor or arr or rrr).ab. or (("OR" or "RR") adj6 CI).ab.)) (5553463)
9  5 and 6 (12) - SR’s
10  (5 and 7) not 9 (25) - RCT’s
11  (5 and 8) not 9 not 10 (35) - observationele studies
12  9 or 10 or 11 (72)

13  5 not 12 (80) – overige studiedesigns

 

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