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Objective <p>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).</p> Methods <p>In this single-center randomized trial, 492 patients were assigned 1:1 to topical TXA (2.5&#xa0;g in 50 mL saline via pericardial drain, clamp 30&#xa0;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.</p> Results <p>RBC transfusion rate was 35.0% (topical) vs. 27.6% (intravenous; 95%CI − 1.2% to 16.0%, <i>P</i> = 0.080). Composite adverse events were 9.8% vs. 15.4% (95%CI − 11.2% to 0.0%, <i>P</i> = 0.057). Topical TXA showed delayed coagulation initiation, lower fibrinogen, and higher 24-hour drainage (all <i>P</i> &lt; 0.05). At 10% margin, efficacy non-inferiority was not confirmed, but safety non-inferiority was verified for all endpoints.</p> Conclusion <p>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.</p> Trial registration <p><a href="http://www.chictr.org.cn">http://www.chictr.org.cn</a>, ChiCTR2500113718, Registration date: 2 December 2025. Retrospectively registratered.</p> Graphical Abstract <p></p>

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

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年5月4日

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  • Dilnaar Tuerhong,
  • Chen‑xi Li,
  • Lei Yan

摘要

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.

Graphical Abstract