Tranexamic Acid Administration Strategies in Cardiovascular Surgery: Goal-directed Tranexamic Acid Administration Based on Viscoelastic Test vs. Empirical Tranexamic Acid Administration

What this Trial Is About

Researchers are conducting a multi-center randomized, placebo-controlled trial to compare two strategies for giving tranexamic acid (TXA) during cardiovascular surgery. The study aims to see if using a viscoelastic test-based, goal-directed TXA administration is not worse than the usual empirical TXA administration in reducing bleeding after surgery. They will also look at differences in blood clot breakdown, blood clots forming in vessels, and seizures after surgery. Participants will receive TXA or a placebo based on either an empirical approach or guided by specific blood clotting tests called rotational thromboelastometry. Four different treatment groups will receive various combinations of TXA and placebo depending on test results. The treatments are given intravenously during surgery, and the study is designed to assess which method better controls bleeding and related complications. Throughout the study, participants will be closely monitored for bleeding amounts through chest tube drainage for 24 hours after surgery. Researchers will track transfusion needs, hemoglobin levels, reoperation rates, seizures, thromboembolic events, kidney function, mechanical ventilation duration, and hospital stay lengths up to one week after surgery. Safety labs and costs will also be evaluated, with follow-up continuing for up to two weeks. This comprehensive monitoring helps understand the impact of each TXA administration method on patient recovery and safety.

Goal-directed vs. Empirical Tranexamic Acid Administrationin Cardiovascular Surgery