Publication: Early cryoprecipitate transfusion versus standard care in severe postpartum haemorrhage:a pilotcluster-randomised trial
Loading...
Official URL
Full text at PDC
Publication Date
2022
Advisors (or tutors)
Editors
Journal Title
Journal ISSN
Volume Title
Publisher
John Wiley & Sons
Citations
Exportar
Abstract
There is a lack of evidence evaluating cryoprecipitate transfusion in severe postpartum haemorrhage. Weperformed a pilot cluster-randomised controlled trial to evaluate the feasibility of a trial on early cryoprecipitatedelivery in severe postpartum haemorrhage. Pregnant women (>24 weeks gestation), actively bleeding within24 h of delivery and who required at least one unit of red blood cells were eligible. Women decliningtransfusion in advance or with inherited clotting deficiencies were not eligible. Four UK hospitals were randomlyallocated to deliver either the intervention (administration of two pools of cryoprecipitate within 90 min offirstred blood cell unit requested plus standard care), or the control group treatment (standard care, wherecryoprecipitate is administered later or not at all). The primary outcome was the proportion of women whoreceived early cryoprecipitate (intervention) vs. standard care (control). Secondary outcomes included consentrates, acceptability of the intervention, safety outcomes and preliminary clinical outcome data to inform adefinitive trial. Between March 2019 and January 2020, 199 participants were recruited; 19 refused consent,leaving 180 for analysis (110 in the intervention and 70 in the control group). Adherence to assigned treatmentwas 32% (95%CI 23–41%) in the intervention group vs. 81% (95%CI 70–90%) in the control group. Theproportion of women receiving cryoprecipitate at any time-point was higher in the intervention (60%) vs. control(31%) groups; the former had fewer red blood cell transfusions at 24 h (mean difference 0.6 units, 95%CI 1.2to 0); overall surgical procedures (odds ratio 0.6, 95%CI 0.3–1.1); and intensive care admissions (odds ratio 0.4,95%CI 0.1–1.1). There was no increase in serious adverse or thrombotic events in the intervention group. Staffinterviews showed that lack of awareness and uncertainty about study responsibilities contributed to loweradherence in the intervention group. We conclude that a full-scale trial may be feasible, provided that protocolrevisions are put in place to establish clear lines of communication for ordering early cryoprecipitate in order toimprove adherence. Preliminary clinical outcomes associated with cryoprecipitate administration areencouraging and merit further investigation.
Description
UCM subjects
Unesco subjects
Keywords
Citation
1. Wise A, Clark V. Strategies to manage major obstetrichaemorrhage.Current Opinion in Anesthesiology2008;21:281–7.
2. Green L, Knight M, Seeney FM, et al. The epidemiology andoutcomes of women with postpartum haemorrhage requiringmassive transfusion with eight or more units of red cells: anational cross-sectional study.British Journal of Obstetrics andGynaecology2016;123: 2164–70.
3. NHS Litigation Authority. Ten Years of Maternity Claims. AnAnalysis of NHS Litigation Authority Data. 2012. https://resolution.nhs.uk/wp-content/uploads/2018/11/Ten-years-of-Maternity-Claims-Final-Report-final-2.pdf (accessed 28/07/2021)
4. Cortet M, Deneux-Tharaux C, Dupont C, et al. Associationbetweenfibrinogen level and severity of postpartumhaemorrhage: secondary analysis of a prospective trial.BritishJournal of Anaesthesia2012;108: 984–9
5. Charbit B, Mandelbrot L, Samain E, et al. The decrease offibrinogen is an early predictor of the severity of postpartumhemorrhage.Journal of Thrombosis and Haemostasis2007;5:266–73.
6. Okada A, Okada Y, Inoue M, Narumiya H, Nakamoto O. Lactateandfibrinogen as good predictors of massive transfusion inpostpartum hemorrhage.Acute Medicine and Surgery2020;7:e453
7. Gayat E, Resche-Rigon M, Morel O, et al. Predictive factors ofadvanced interventional procedures in a multicentre severepostpartum haemorrhage study.Intensive Care Medicine2011;37: 1816–25.
8. Mavrides EAS, Chandraharan E, Collins P, et al. on behalf of theRoyal College of Obstetricians and Gynaecologists. Preventionand management of postpartum haemorrhage.British Journalof Obstetrics and Gynaecology2016; e106–9.
9.unt BJ, Allard S, Keeling D, Norfolk D, Stanworth SJ, Pendry K.A practical guideline for the haematological management ofmajor haemorrhage.British Journal of Haematology2015;170:788–803.
10. Green L, Knight M, Seeney F, et al. The haematological featuresand transfusion management of women who required massivetransfusion for major obstetric haemorrhage in the UK: apopulation based study. British Journal of Haematology2016;172: 616–24.
11. Zaidi A, Kohli R, Daru J, et al. Early use offibrinogenreplacement therapy in postpartum hemorrhage-a systematicreview.Transfusion Medicine Review2020;34: 101–7.
12. Green L, Daru J, Dodds J, et al. Effect of early cryoprecipitatetransfusion versus standard care in women who develop severe postpartum haemorrhage (ACROBAT) in the UK: a protocol fora pilot cluster randomised trial.British Medical Journal Open2020;10: e036416
13. Bateman BT, Berman MF, Riley LE, Leffert LR. The epidemiologyof postpartum hemorrhage in a large, nationwide sample ofdeliveries.Anesthesia and Analgesia2010;110: 1368–73.
14. Healthcare Improvement Scotland. Scottish Confidential Audit of Severe Maternal Morbidity: reducing avoidable harm. 10thAnnual Report. 2014. https://www.healthcareimprovementscotland.org/our_work/reproductive,_maternal_child/programme_resources/scasmm.aspx (accessed 28/07/2021).
15. Brown LD, Cai TT, DasGupta A. Interval estimation for abinomial proportion.Statistical Science2001;16: 101–33.
16. Moss N, Daru J, Lanz D, Thangaratinam S, Khan KS. Involvingpregnant women, mothers and members of the public toimprove the quality of women’s health research.British Journalof Obstetrics and Gynaecology2017;124: 362–5.
17. Eldridge SM, Costelloe CE, Kahan BC, Lancaster GA, Kerry SM.How big should the pilot study for my cluster randomised trialbe?Statistical Methods in Medical Research2016;25: 1039–56.
18. Stanworth SJ, Davenport R, Curry N, et al. Mortality from traumahaemorrhage and opportunities for improvement intransfusion practice.British Journal of Surgery2016;103: 357–65.
19. Collins PW, Cannings-John R, Bruynseels D, et al.Viscoelastometric-guided earlyfibrinogen concentratereplacement during postpartum haemorrhage: OBS2, adouble-blind randomized controlled trial.British Journal ofAnaesthesia2017;119: 411–21.
20. Wikkelsø AJ, Edwards HM, Afshari A, et al. Pre-emptivetreatment withfibrinogen concentrate for postpartumhaemorrhage: randomized controlled trial.British Journal ofAnaesthesia2015;114: 623–33.
21. Tama MA, Stone ME Jr, Blumberg SM, Reddy SH, Conway EE Jr,Meltzer JA. Association of Cryoprecipitate Use With SurvivalAfter Major Trauma in Children Receiving Massive Transfusion.Journal of the American Medical Association Surgery2021;156: 453–60.
22. Green L, Backholer L, Wiltshire M, Platton S, Stanworth SJ,Cardigan R. The hemostatic properties of thawed pooledcryoprecipitate up to 72 hours.Transfusion2016;56: 1356–61.
23. Green L, Bolton-Maggs P, Beattie C, et al. British Society ofHaematology Guidelines on the spectrum of fresh frozenplasma and cryoprecipitate products: their handling and use invarious patient groups in the absence of major bleeding.BritishJournal of Haematology2018;181:54–67.
24. Morrow GB, Carlier MSA, Dasgupta S, Craigen FB, Mutch NJ,Curry N. Fibrinogen replacement therapy for traumaticcoagulopathy: does thefibrinogen source matter?InternationalJournal of Molecular Science2021;22: 2185.
25. Marsden M, Benger J, Brohi K, et al. Coagulopathy,cryoprecipitate and CRYOSTAT-2: realising the potential of anationwide trauma system for a national clinical trial.BritishJournal of Anaesthesia2019;122: 164–9.
26. Fenderson JL, Meledeo MA, Rendo MJ, et al. Hemostaticcharacteristics of thawed, pooled cryoprecipitate stored for 35days at refrigerated and room temperatures.Transfusion2019;59: 1560–7