Comparing Different Dosages of Tranexamic Acid During Cardiac Surgery Using Cardiopulmonary Bypass to Measure Blood Clotting Effects

What this Trial Is About

Researchers are studying different dosages of tranexamic acid in adults undergoing elective cardiac surgery with cardiopulmonary bypass to understand how long the drug inhibits fibrinolysis, which helps prevent excessive bleeding. This trial aims to find the best dosage regimen by measuring clotting function and drug levels in the blood. The study is randomized and quadruple-masked to compare three dosing strategies and their impact on blood loss and related complications. Participants will be randomly assigned to one of three groups receiving tranexamic acid a 10 mgkg dose followed by a continuous infusion of 1 mgkg per hour until surgery ends, a single 20 mgkg dose, or a single 30 mgkg dose given before surgery starts. Blood samples will be collected at multiple time points during and after surgery to perform ClotPro viscoelastic testing and measure tranexamic acid levels. If clotting inhibition decreases early, an additional 10 mgkg dose is given. Throughout the study, researchers will collect detailed information including patient characteristics, surgery duration, anesthesia details, blood transfusions, bleeding amounts, and any adverse events. Postoperative care data such as mechanical ventilation duration, ICU and hospital stays, and mortality will also be tracked. The primary measurement is the duration of fibrinolysis inhibition as indicated by ClotPro results and its correlation with tranexamic acid blood levels. Secondary outcomes include bleeding, transfusion needs, seizures, thrombotic events, and length of recovery up to one year after surgery.

Comparative Study of Tranexamic Acid Dosing in Cardiac Surgery