Early cryoprecipitate transfusion versus standard care in severe postpartum haemorrhage: a pilot cluster-randomised trial Green, L. Saeed Khan, Khalid Haematological agents Haemostatics Pilot projects Postpartum haemorrhage The trial was prospectively registered on ISRCTN (12146519). The trial was approved by the NHS LondonBrighton and Sussex Research Ethics Committee and the NHS Confidentiality Advisory Group. The study was funded by Barts Charity. We would like to acknowledge the support of the Joint Research Management Office, Queen Mary University of London as sponsor for the study; the contributions of members of Katie's Team, the East London women's health research patient and public advisory group; and the clinical, laboratory and maternity research teams at Barts Health NHS Trust hospitals and Homerton University Hospital. We are also grateful for all the support and advice provided by the project steering committee chaired by an independent consultant anaesthetist (M. Wilson, University of Sheffield), with four other independent members: A. Khalil, St George's University Hospital; B. Leurent, London School of Hygiene and Tropical Medicine; N. Moss, lay representative; and S. Robinson, Guy's and St Thomas' NHS Trust. No other external funding or competing interests declared. There is a lack of evidence evaluating cryoprecipitate transfusion in severe postpartum haemorrhage. We performed a pilot cluster-randomised controlled trial to evaluate the feasibility of a trial on early cryoprecipitate delivery in severe postpartum haemorrhage. Pregnant women (>24 weeks gestation), actively bleeding within 24 h of delivery and who required at least one unit of red blood cells were eligible. Women declining transfusion in advance or with inherited clotting deficiencies were not eligible. Four UK hospitals were randomly allocated to deliver either the intervention (administration of two pools of cryoprecipitate within 90 min of first red blood cell unit requested plus standard care), or the control group treatment (standard care, where cryoprecipitate is administered later or not at all). The primary outcome was the proportion of women who received early cryoprecipitate (intervention) vs. standard care (control). Secondary outcomes included consent rates, acceptability of the intervention, safety outcomes and preliminary clinical outcome data to inform a definitive 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 treatment was 32% (95%CI 23–41%) in the intervention group vs. 81% (95%CI 70–90%) in the control group. The proportion 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 1.2 to 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. Staff interviews showed that lack of awareness and uncertainty about study responsibilities contributed to lower adherence in the intervention group. We conclude that a full-scale trial may be feasible, provided that protocol revisions are put in place to establish clear lines of communication for ordering early cryoprecipitate in order to improve adherence. Preliminary clinical outcomes associated with cryoprecipitate administration are encouraging and merit further investigation. 2021-11-08T09:27:09Z 2021-11-08T09:27:09Z 2021-10-20 journal article Green, L... [et al.] (2021), Early cryoprecipitate transfusion versus standard care in severe postpartum haemorrhage: a pilot cluster-randomised trial. Anaesthesia. [https://doi.org/10.1111/anae.15595] http://hdl.handle.net/10481/71353 10.1111/anae.15595 eng http://creativecommons.org/licenses/by-nc-nd/3.0/es/ open access Atribución-NoComercial-SinDerivadas 3.0 España John Wiley & Sons