Background

Coagulopathy in cardiac surgery is frequently associated with acquired hypofibrinogenaemia, which can be treated with either purified fibrinogen concentrate (FC) or cryoprecipitate. Because the latter is not purified and therefore contains additional coagulation factors, it is thought to be more effective for treatment of coagulopathy that occurs after prolonged cardiopulmonary bypass (CPB). We examined the impact of CPB duration on the efficacy of the two therapies in cardiac surgery.

Methods

This was a post hoc analysis of the Fibrinogen Replenishment in Surgery (FIBRES) RCT comparing FC (4 g) to cryoprecipitate (10 U) in adult patients undergoing cardiac surgery and experiencing bleeding with acquired hypofibrinogenaemia (n=735). The primary outcome was allogeneic blood products transfused within 24 h after CPB. Subjects were stratified by CPB duration (≤120, 121–180, and >180 min). The interaction of treatment assignment with CPB duration was tested.

Results

Subjects with longer CPB duration experienced more bleeding and transfusion. With CPB time ≤120 min (FC, n=134; cryoprecipitate, n=146), the ratio of least-squares means between the FC and cryoprecipitate groups for total allogeneic blood products at 24 h was 0.90 (one-sided 97.5% confidence interval [CI]: 0.00–1.12); P=0.004. For subjects with CPB time 121–180 min, it was 1.00 ([one-sided 97.5% CI: 0.00–1.22]; P=0.03], and for CPB time >180 min it was 0.91 ([one-sided 97.5% CI: 0.00–1.12]; P=0.005). Results were similar for all secondary outcomes, with no interaction between treatment and CPB duration for all outcomes.

Conclusions

The haemostatic efficacy of FC was non-inferior to cryoprecipitate irrespective of CPB duration in cardiac surgery.

Clinical trial registration

NCT03037424.

中文翻译：

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与纤维蛋白原浓缩物相比，体外循环持续时间对用冷沉淀替代纤维蛋白原疗效的影响：手术中纤维蛋白原补充 (FIBRES) 随机对照试验的事后分析

背景

心脏手术中的凝血病通常与获得性低纤维蛋白原血症有关，可以使用纯化的纤维蛋白原浓缩物 (FC) 或冷沉淀物进行治疗。由于后者未经纯化，因此含有额外的凝血因子，因此被认为对治疗长时间体外循环 (CPB) 后发生的凝血病更有效。我们检查了 CPB 持续时间对心脏手术中两种疗法的疗效的影响。

方法

这是一项对手术中纤维蛋白原补充 (FIBRES) RCT的事后分析，比较了接受心脏手术并经历获得性低纤维蛋白原血症出血的成年患者的 FC (4 g) 与冷沉淀 (10 U) ( n = 735)。主要结果是体外循环后 24 小时内输注异体血液制品。受试者按 CPB 持续时间（≤120、121-180 和 >180 分钟）进行分层。测试了治疗分配与 CPB 持续时间的相互作用。

结果

CPB 持续时间较长的受试者经历了更多的出血和输血。CPB 时间≤120 分钟（FC，n = 134；冷沉淀，n = 146），FC 组和冷沉淀组 24 小时总异体血液制品的最小二乘均值比为 0.90（单边 97.5% 置信度区间 [CI]：0.00–1.12)；P = 0.004。对于 CPB 时间 121-180 分钟的受试者，它是 1.00（[单侧 97.5% CI：0.00-1.22]；P = 0.03]，对于 CPB 时间>180 分钟，它是 0.91（[单侧 97.5% CI : 0.00–1.12]; P = 0.005). 所有次要结局的结果相似，所有结局的治疗和 CPB 持续时间之间没有交互作用。

结论

无论心脏手术中的 CPB 持续时间如何，FC 的止血效果均不劣于冷沉淀。

临床试验注册

NCT03037424。