Early cryoprecipitate transfusion versus standard care in severe postpartum haemorrhage:a pilotcluster-randomised trial

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