Goal-directed vs. Empirical Tranexamic Acid Administrationin Cardiovascular Surgery

The present study is a multi-center randomized prospective placebo-controlled non-inferiority trial. The study's primary objective is to compare the amounts of postoperative bleeding using two different TXA administration strategies: empirical TXA administration vs. viscoelastic test-based goal-directed TXA administration in cardiovascular surgery. The secondary objectives include comparing the incidents of hyper-fibrinolysis, thromboembolic complications, and postoperative seizures. Researchers assumed that goal-directed tranexamic acid (TXA) administration using viscoelastic field tests would not be inferior to the empirical TXA administration strategy in reducing postoperative bleeding and hyper-fibrinolysis. It also would be beneficial in lowering TXA-induced thromboembolic complications and seizures.

NCT Number	NCT05806346
Lead Sponsor	Konkuk University Medical Center Collaborators: Korea Health Industry Development Institute, Helptrial, Asan Medical Center, Samsung Medical Center
Conditions	Heart Diseases, Vascular Diseases, Transfusion Related Complication, Coagulation Disorder, Blood, Fibrinolysis; Hemorrhage
Enrollment	764 participants
Start Date	2023-08-01
Primary Completion	2025-04-30 (estimated)
Study Completion	2025-06-30 (estimated)
Updated on ClinicalTrials.gov	2024-12-18