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在接受静脉注射氨甲环酸的心脏手术患者中,心包灌洗联合或不联合氨甲环酸的有效性:一项随机对照试验。

Effectiveness of pericardial lavage with or without tranexamic acid in cardiac surgery patients receiving intravenous tranexamic acid: a randomized controlled trial.

作者信息

Kimenai Dorien M, Gerritse Bastiaan M, Lucas Cees, Rosseel Peter M, Bentala Mohamed, van Hattum Paul, van der Meer Nardo J M, Scohy Thierry V

机构信息

Department of Extracorporeal Circulation, Amphia Hospital, Breda, Netherlands.

Department of Anesthesiology, Amphia Hospital, Breda, Netherlands.

出版信息

Eur J Cardiothorac Surg. 2016 Dec;50(6):1124-1131. doi: 10.1093/ejcts/ezw214. Epub 2016 Jun 21.

Abstract

OBJECTIVES

Pericardial lavage with saline, with or without tranexamic acid (TA), is still not evidence-based within current clinical practice as a part of a blood conservation strategy in cardiac surgery patients receiving intravenous TA administration. The objective was to determine whether intravenous TA combined with pericardial lavage with saline, with or without TA, reduces blood loss by 25% after cardiac surgery measured in the first 12 h postoperatively.

METHODS

In this single-centre, randomized controlled, multiple-armed, parallel study, individual patients were randomly assigned to receive either topical administration of 2 g TA diluted in 200 ml of saline (TA group), 200 ml of saline (placebo group) or no topical administration at all (control group). Eligible participants were all adults aged 18 or older and scheduled for elective cardiac surgery on cardiopulmonary bypass. All patients received 2 g TA intravenously before sternal incision and 2 g TA after cardiopulmonary bypass. The main outcome measure was the 12-h postoperative blood loss.

RESULTS

In total, 739 individuals were analysed according to intention-to-treat analyses (TA group, n = 245 patients; placebo group, n = 249 patients; control group, n = 245 patients). There was no difference in the median 12-h postoperative blood loss between the three groups [TA group, 290 (IQR 190-430) ml; placebo group, 290 (IQR 210-440) ml; control group, 300 (IQR 190-450) ml, P= 0.759].

CONCLUSIONS

Pericardial lavage, with or without TA, does not result in a statistically significant difference in the 12-h postoperative blood loss in cardiac surgery patients receiving intravenous TA administration. Pericardial lavage with saline, with or without TA, should not be a part of a blood conservation strategy.

摘要

目的

对于接受静脉注射氨甲环酸(TA)的心脏手术患者,作为血液保护策略的一部分,心包内用生理盐水冲洗,无论是否添加TA,目前在临床实践中仍缺乏循证依据。本研究旨在确定静脉注射TA联合心包内用生理盐水冲洗(无论是否添加TA)能否使心脏手术后12小时内的失血量减少25%。

方法

在这项单中心、随机对照、多臂平行研究中,将个体患者随机分配,分别接受2克TA稀释于200毫升生理盐水中的局部给药(TA组)、200毫升生理盐水(安慰剂组)或完全不进行局部给药(对照组)。符合条件的参与者均为18岁及以上的成年人,计划接受体外循环下的择期心脏手术。所有患者在胸骨切开术前静脉注射2克TA,体外循环后再注射2克TA。主要结局指标为术后12小时的失血量。

结果

根据意向性分析,共纳入739例患者(TA组,n = 245例患者;安慰剂组,n = 249例患者;对照组,n = 245例患者)。三组术后12小时失血量中位数无差异[TA组,290(IQR 190 - 430)毫升;安慰剂组,290(IQR 210 - 440)毫升;对照组,300(IQR 190 - 450)毫升,P = 0.759]。

结论

对于接受静脉注射TA的心脏手术患者,心包冲洗无论是否添加TA,术后12小时失血量均无统计学显著差异。心包内用生理盐水冲洗,无论是否添加TA,均不应作为血液保护策略的一部分。

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