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[JAMA在线发表]:心脏外科术后使用纤维蛋白原浓缩物或冷沉淀对于输注血液制品的影响
2019年10月28日 时讯速递, 进展交流 暂无评论

October 21, 2019

Effect of Fibrinogen Concentrate vs Cryoprecipitate on Blood Component Transfusion After Cardiac Surgery: The FIBRES Randomized Clinical Trial

Jeannie Callum, Michael E. Farkouh, Damon C. Scales, et al

JAMA. Published online October 21, 2019. doi:10.1001/jama.2019.17312

Abstract

Importance 背景

Excessive bleeding is a common complication of cardiac surgery. An important cause of bleeding is acquired hypofibrinogenemia (fibrinogen level <1.5-2.0 g/L), for which guidelines recommend fibrinogen replacement with cryoprecipitate or fibrinogen concentrate. The 2 products have important differences, but comparative clinical data are lacking.

出血过多是心脏手术的常见并发症。获得性低纤维蛋白原血症(纤维蛋白原水平<1.5-2.0 g/L)是导致出血的重要原因,指南推荐输注冷沉淀或纤维蛋白原浓缩物补充纤维蛋白原。这2种产品具有重要的差别,但是尚缺乏临床资料进行比较。

Objective 目的

To determine if fibrinogen concentrate is noninferior to cryoprecipitate for treatment of bleeding related to hypofibrinogenemia after cardiac surgery.

确定心脏外科手术后治疗低纤维蛋白原血症相关出血时,纤维蛋白原浓缩物不劣于冷沉淀。

Design, Setting, and Participants 设计、场景和研究人群

Randomized clinical trial at 11 Canadian hospitals enrolling adult patients experiencing clinically significant bleeding and hypofibrinogenemia after cardiac surgery (from February 10, 2017, to November 1, 2018). Final 28-day follow-up visit was completed on November 28, 2018.

这项随机临床试验在加拿大11所医院进行,纳入心脏外科术后出现明显出血及低纤维蛋白原血症的成年患者(从2017年2月10日至2018年11月1日)。最后28天随访于2018年11月28日结束。

Interventions 干预措施

Fibrinogen concentrate (4 g; n = 415) or cryoprecipitate (10 units; n = 412) for each ordered dose within 24 hours after cardiopulmonary bypass.

心肺旁路手术后24小时内,每次医嘱给予纤维蛋白原浓缩物 (4 g; n = 415) 或冷沉淀 (10 个单位; n = 412)。

Main Outcomes and Measures 主要预后指标

Primary outcome was blood components (red blood cells, platelets, plasma) administered during 24 hours post bypass. A 2-sample, 1-sided test for the ratio of the mean number of units was conducted to evaluate noninferiority (threshold for noninferiority ratio, <1.2).

主要预后终点为心肺旁路术后24小时内输注的血液制品(红细胞,血小板和血浆)。对输注血液制品平均单位数的比值进行2个样本单侧检验,以评价非劣效(非劣效比值阈值, <1.2)。

Results 结果

Of 827 randomized patients, 735 (372 fibrinogen concentrate, 363 cryoprecipitate) were treated and included in the primary analysis (median age, 64 [interquartile range, 53-72] years; 30% women; 72% underwent complex operations; 95% moderate to severe bleeding; and pretreatment fibrinogen level, 1.6 [interquartile range, 1.3-1.9] g/L). The trial met the a priori stopping criterion for noninferiority at the interim analysis after 827 of planned 1200 patients were randomized. Mean 24-hour postbypass allogeneic transfusions were 16.3 (95% CI, 14.9 to 17.8) units in the fibrinogen concentrate group and 17.0 (95% CI, 15.6 to 18.6) units in the cryoprecipitate group (ratio, 0.96 [1-sided 97.5% CI, −∞ to 1.09; P < .001 for noninferiority] [2-sided 95% CI, 0.84 to 1.09; P = .50 for superiority]). Thromboembolic events occurred in 26 patients (7.0%) in the fibrinogen concentrate group and 35 patients (9.6%) in the cryoprecipitate group.

共有827名患者接受随机分组,其中 735 (372 名纤维蛋白原浓缩物, 363 名冷沉淀) 接受治疗并纳入主要分析 (中位年龄, 64 [四分位区间, 53-72] 岁; 30% 女性; 72% 接受复杂手术; 95% 中重度出血; 治疗钱纤维蛋白原水平, 1.6 [四分位区间, 1.3-1.9] g/L)。试验预计样本量1200名患者,827名患者入选后进行的中期分析发现,试验符合预先确定的非劣效终止标准。心肺旁路后24小时平均输血量,纤维蛋白原浓缩物组为 16.3 (95% CI, 14.9 to 17.8) 单位,冷沉淀组 17.0 (95% CI, 15.6 to 18.6) 单位 (比值, 0.96 [单侧 97.5% CI, −∞ to 1.09; 非劣效P < .001] [双侧 95% CI, 0.84 to 1.09; 非劣效P = .50])。纤维蛋白原浓缩物组26名 (7.0%) 患者及冷沉淀组35名 (9.6%) 患者发生血栓栓塞事件。

Conclusions and Relevance 结论与意义

In patients undergoing cardiac surgery who develop clinically significant bleeding and hypofibrinogenemia after cardiopulmonary bypass, fibrinogen concentrate is noninferior to cryoprecipitate with regard to number of blood components transfused in a 24-hour period post bypass. Use of fibrinogen concentrate may be considered for management of bleeding in patients with acquired hypofibrinogenemia in cardiac surgery.

对于心肺旁路后发生临床明显出血且合并低纤维蛋白原血症的心脏外科术后患者,输注纤维蛋白原浓缩物对于心肺旁路后24消失输注血液制品量不劣于冷沉淀。对于心脏外科术后获得性低纤维蛋白原血症患者,可以考虑使用纤维蛋白原浓缩物治疗出血。

Trial Registration 试验注册

ClinicalTrials.gov Identifier: NCT03037424

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