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.

中文翻译：

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严重产后出血的早期冷沉淀输血与标准护理：一项初步集群随机试验

缺乏评估冷沉淀输血治疗严重产后出血的证据。我们进行了一项试验性整群随机对照试验，以评估在严重产后出血中进行早期冷沉淀递送试验的可行性。孕妇（>24 孕周）、分娩后 24 小时内出血活跃且需要至少 1 个单位红细胞的孕妇符合条件。提前拒绝输血或有遗传性凝血缺陷的妇女不符合条件。四家英国医院被随机分配以提供干预（在要求的第一个红细胞单位后 90 分钟内给予两个冷沉淀池加上标准护理）或对照组治疗（标准护理，冷沉淀在以后或不在全部）。主要结果是接受早期冷沉淀（干预）与标准护理（对照）的女性比例。次要结果包括同意率、干预的可接受性、安全性结果和初步临床结果数据，为最终试验提供信息。2019 年 3 月至 2020 年 1 月期间，招募了 199 名参与者；19 人拒绝同意，剩下 180 人进行分析（干预组 110 人，对照组 70 人）。干预组对指定治疗的依从性为 32% (95%CI 23–41%)，而对照组为 81% (95%CI 70–90%)。干预组（60%）与对照组（31%）相比，在任何时间点接受冷沉淀的女性比例均较高；前者在 24 小时输注红细胞较少（平均差 -0.6 单位，95%CI -1.2 至 0）；整体外科手术（优势比 0.6, 95%CI 0.3–1.1）；和重症监护（优势比 0.4, 95%CI 0.1–1.1）。干预组的严重不良事件或血栓事件没有增加。工作人员访谈表明，缺乏对研究责任的认识和不确定性导致干预组的依从性降低。我们得出结论，全面试验可能是可行的，前提是对方案进行修订以建立清晰的沟通渠道，以便订购早期冷沉淀，以提高依从性。与冷沉淀给药相关的初步临床结果令人鼓舞，值得进一步研究。干预组的严重不良事件或血栓事件没有增加。工作人员访谈表明，缺乏对研究责任的认识和不确定性导致干预组的依从性降低。我们得出结论，全面试验可能是可行的，前提是对方案进行修订以建立清晰的沟通渠道，以便订购早期冷沉淀，以提高依从性。与冷沉淀给药相关的初步临床结果令人鼓舞，值得进一步研究。干预组的严重不良事件或血栓事件没有增加。工作人员访谈表明，缺乏对研究责任的认识和不确定性导致干预组的依从性降低。我们得出结论，全面试验可能是可行的，前提是对方案进行修订以建立清晰的沟通渠道，以便订购早期冷沉淀，以提高依从性。与冷沉淀给药相关的初步临床结果令人鼓舞，值得进一步研究。前提是对方案进行修订，以建立清晰的沟通渠道，以便订购早期冷沉淀，以提高依从性。与冷沉淀给药相关的初步临床结果令人鼓舞，值得进一步研究。前提是对方案进行修订，以建立清晰的沟通渠道，以便订购早期冷沉淀，以提高依从性。与冷沉淀给药相关的初步临床结果令人鼓舞，值得进一步研究。