Topical use of tranexamic acid for antifibrinolysis in cardiac surgery with cardiopulmonary bypass: a randomized clinical study.

IF 2.6 3区医学 Q2 ANESTHESIOLOGY

BMC Anesthesiology Pub Date : 2026-05-04 DOI:10.1186/s12871-026-03872-2

Dilnaar Tuerhong, Chen-Xi Li, Lei Yan

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引用次数: 0

Abstract

Objective: To assess the non-inferiority of topical intrapericardial tranexamic acid (TXA) versus intravenous TXA for efficacy and safety in patients undergoing cardiac surgery with cardiopulmonary bypass (CPB).

Methods: In this single-center randomized trial, 492 patients were assigned 1:1 to topical TXA (2.5 g in 50 mL saline via pericardial drain, clamp 30 min) or standard intravenous TXA.

Primary endpoints: allogeneic red blood cell (RBC) transfusion rate (postoperative to discharge); 30-day composite adverse events (mortality, renal dysfunction, stroke, myocardial infarction, thromboembolism, seizures). Secondary endpoints included drainage volume, coagulation, and thromboelastography (TEG). The non-inferiority threshold was established at 10% for sensitivity.

Results: RBC transfusion rate was 35.0% (topical) vs. 27.6% (intravenous; 95%CI - 1.2% to 16.0%, P = 0.080). Composite adverse events were 9.8% vs. 15.4% (95%CI - 11.2% to 0.0%, P = 0.057). Topical TXA showed delayed coagulation initiation, lower fibrinogen, and higher 24-hour drainage (all P < 0.05). At 10% margin, efficacy non-inferiority was not confirmed, but safety non-inferiority was verified for all endpoints.

Conclusion: Topical intrapericardial TXA is non-inferior to intravenous TXA in safety but fails strict efficacy non-inferiority. Intravenous TXA remains first-line; topical TXA is a reasonable alternative for patients intolerant to systemic administration. Dose and timing optimization is needed to improve hemostasis.

Trial registration: http://www.chictr.org.cn, ChiCTR2500113718, Registration date: 2 December 2025. Retrospectively registratered.

查看原文本刊更多论文

局部使用氨甲环酸抗纤溶在心脏手术与体外循环：一项随机临床研究。

目的：评价外用心包内氨甲环酸（TXA）与静脉注射TXA在心脏手术合并体外循环（CPB）患者中的疗效和安全性的非劣效性。方法：在这项单中心随机试验中，492例患者按1:1的比例被分配到外用TXA组（2.5 g 50ml生理盐水经心包引流，钳夹30min）或标准静脉注射TXA组。主要终点：异基因红细胞（RBC）输血率（术后至出院）；30天复合不良事件（死亡率、肾功能不全、中风、心肌梗死、血栓栓塞、癫痫发作）。次要终点包括引流量、凝血和血栓弹性成像（TEG）。非劣效阈值为10%的敏感性。结果：红细胞输注率为35.0%（局部）vs. 27.6%（静脉）；95%CI - 1.2% ~ 16.0%, P = 0.080。综合不良事件为9.8%比15.4% （95%CI - 11.2% ~ 0.0%, P = 0.057）。结论：心包内外用TXA在安全性上不逊于静脉注射，但在严格疗效上不逊于静脉注射。静脉注射TXA仍然是第一线；对于不耐受全身给药的患者，外用TXA是一种合理的选择。需要优化剂量和时间来改善止血。试验注册：http://www.chictr.org.cn, ChiCTR2500113718，注册日期：2025年12月2日。回顾性registratered。

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来源期刊

BMC Anesthesiology ANESTHESIOLOGY-

CiteScore

3.50

自引率

4.50%

发文量

349

审稿时长

>12 weeks

期刊介绍： BMC Anesthesiology is an open access, peer-reviewed journal that considers articles on all aspects of anesthesiology, critical care, perioperative care and pain management, including clinical and experimental research into anesthetic mechanisms, administration and efficacy, technology and monitoring, and associated economic issues.