Trial reportBMC anesthesiology2026
Topical use of tranexamic acid for antifibrinolysis in cardiac surgery with cardiopulmonary bypass: a randomized clinical study.
Trial report in BMC anesthesiology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Authors and funding
3 authors.
Funding
Abstract
objectiveTo 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).
methodsIn 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.
resultsRBC 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.
conclusionTopical 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 registrationhttp://www.chictr.org.cn , ChiCTR2500113718, Registration date: 2 December 2025. Retrospectively registratered.
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