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

764 Participants
are divided into 4 treatment groups

Locations

3
Asan Medical Center Seoul South Korea
Konkuk University Medical Center05030, Seoul South Korea
Samsung Medical Center06351, Seoul South Korea

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