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Goal-directed vs. Empirical Tranexamic Acid Administrationin Cardiovascular Surgery
Sponsor: Konkuk University Medical Center
Summary
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.
Official title: Tranexamic Acid Administration Strategies in Cardiovascular Surgery: Goal-directed Tranexamic Acid Administration Based on Viscoelastic Test vs. Empirical Tranexamic Acid Administration
Key Details
Gender
All
Age Range
19 Years - Any
Study Type
INTERVENTIONAL
Enrollment
764
Start Date
2023-08-01
Completion Date
2025-06-30
Last Updated
2024-12-18
Healthy Volunteers
No
Conditions
Interventions
TXA administration
Tranexamic acid intravenous administration
Placebo administration
Placebo (normal saline) intravenous administration
Locations (3)
Konkuk University Medical Center
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
Asan Medical Center
Seoul, South Korea