About this trial
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.
Eligibility criteria
Qualifiers
patients who will undergo elective cardiovascular surgery employing cardiopulmonary bypass
patients who provide written informed consent
Disqualifiers
pregnancy
refusal of allogenic blood transfusion
taking thrombin
history of thromboembolic and familial hypercoagulability disease
Trial design
Treatments tested in this trial
- TXA administration
- Placebo administration
Treatment groups
Sponsors and collaborators
Konkuk University Medical Center
Lead sponsor
Korea Health Industry Development Institute
Collaborator
Helptrial
Collaborator
Asan Medical Center
Collaborator
Samsung Medical Center
Collaborator