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[JAMA最新论文]:合并术中出血的高危心脏手术患者输注纤维蛋白原不能减少术中出血
2017年02月26日 时讯速递, 进展交流 暂无评论

Original Investigation

February 21, 2017

Effect of Fibrinogen Concentrate on Intraoperative Blood Loss Among Patients With Intraoperative Bleeding During High-Risk Cardiac SurgeryA Randomized Clinical Trial

Süleyman Bilecen, Joris A. H. de Groot, Cor J. Kalkman, et al

JAMA. 2017;317(7):738-747.

doi:10.1001/jama.2016.21037

Abstract 摘要

Importance 背景

Fibrinogen concentrate might partly restore coagulation defects and reduce intraoperative bleeding.

纤维蛋白原可以部分恢复凝血异常从而减少术中出血。

Objective 目的

To determine whether fibrinogen concentrate infusion dosed to achieve a plasma fibrinogen level of 2.5 g/L in high-risk cardiac surgery patients with intraoperative bleeding reduces intraoperative blood loss.

确定对于术中出血的高危心脏外科患者,输注纤维蛋白原并使血浆纤维蛋白原水平达到2.5 g/L,能否减少术中出血。

Design, Setting, and Participants 设计,场景及研究人群

A randomized, placebo-controlled, double-blind clinical trial conducted in Isala Zwolle, the Netherlands (February 2011-January 2015), involving patients undergoing elective, high-risk cardiac surgery (ie, combined coronary artery bypass graft [CABG] surgery and valve repair or replacement surgery, the replacement of multiple valves, aortic root reconstruction, or reconstruction of the ascending aorta or aortic arch) with intraoperative bleeding (blood volume between 60 and 250 mL suctioned from the thoracic cavity in a period of 5 minutes) were randomized to receive either fibrinogen concentrate or placebo.

这是一项随机、安慰剂对照、双盲临床试验,2011年2月至2015年1月在荷兰的Isala Zwolle进行,纳入接受择期高危心脏手术(即联合冠脉搭桥[CABG]及瓣膜修补或置换手术,多个瓣膜置换手术,主动脉根部重建,或升主动脉或主动脉弓重建手术)且术中出血(5分钟内胸腔内吸引60 - 250 mL血)的患者。患者被随机分为纤维蛋白原组或安慰剂组。

Interventions 治疗措施

Intravenous, single-dose administration of fibrinogen concentrate (n = 60) or placebo (n = 60), targeted to achieve a postinfusion plasma fibrinogen level of 2.5 g/L.

静脉单次输注纤维蛋白原(n = 60)或安慰剂(n = 60),使输注后血浆纤维蛋白原水平达到2.5 g/L。

Main Outcomes and Measures 主要预后指标

The primary outcome was blood loss in milliliters between intervention (ie, after removal of cardiopulmonary bypass) and closure of chest. Safety variables (within 30 days) included: in-hospital mortality, myocardial infarction, cerebrovascular accident or transient ischemic attack, renal insufficiency or failure, venous thromboembolism, pulmonary embolism, and operative complications.

主要预后指标为干预治疗(即停止心肺旁路后)至关胸期间出血量。安全指标(30天内)包括住院病死率、心肌梗塞,脑血管意外或一过性缺血发作,肾功能不全或衰竭,静脉血栓栓塞,肺动脉栓塞,及手术并发症。

Results 结果

Among 120 patients (mean age; 71 [SD, 10] years, 37 women [31%]) included in the study, combined CABG and valve repair or replacement surgery comprised 72% of procedures and had a mean (SD) cardiopulmonary bypass time of 200 minutes (83) minutes. For the primary outcome, median blood loss in the fibrinogen group was 50 mL (interquartile range [IQR], 29-100 mL) compared with 70 mL (IQR, 33-145 mL) in the control group (P = .19), the absolute difference 20 mL (95% CI, −13 to 35 mL). There were 6 cases of stroke or transient ischemic attack (4 in the fibrinogen group); 4 myocardial infarctions (3 in the fibrinogen group); 2 deaths (both in the fibrinogen group); 5 cases with renal insufficiency or failure (3 in the fibrinogen group); and 9 cases with reoperative thoracotomy (4 in the fibrinogen group).

研究入选的120名患者中(平均年龄71 [SD, 10]岁,女性37名[31%]),联合CABG及瓣膜修补或置换术占72%,平均心肺旁路时间(SD)为200 (83)分钟。纤维蛋白原组主要预后指标即出血量中位数为50 mL(四分位区间[IQR] 29-100 mL),对照组为70 mL (IQR, 33-145 mL) (P = .19),绝对差异为20 mL (95% CI, −13 to 35 mL)。共发生6例卒中或一过性缺血发作(纤维蛋白原组4例),4例心肌梗塞(纤维蛋白原组3例),2例死亡(均为纤维蛋白原组),5例肾功能不全或衰竭(纤维蛋白原组3例)及9例再次开胸手术(纤维蛋白原组4例)。

Conclusions and Relevance 结论与意义

Among patients with intraoperative bleeding during high-risk cardiac surgery, administration of fibrinogen concentrate, compared with placebo, resulted in no significant difference in the amount of intraoperative blood loss.

对于术中出血的高危心脏手术患者,与安慰剂对照相比,输注纤维蛋白原不能显著减少术中出血量。

Trial Registration

clinicaltrials.gov Identifier: NCT01124981 and EudraCT No: 2009-018086-12

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