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.
patients who will undergo elective cardiovascular surgery employing cardiopulmonary bypass
patients who provide written informed consent
pregnancy
refusal of allogenic blood transfusion
taking thrombin
history of thromboembolic and familial hypercoagulability disease
Parallel
TXA administration
DrugTranexamic acid intravenous administration
Placebo administration
DrugPlacebo (normal saline) intravenous administration
postoperative bleeding
bleeding amount though chest drainage tubes during the 1st postoperative 24 hour
postoperative transfusion amount
amounts of transfused red blood cells, plasma, platelet and cryoprecipitate
postoperative transfusion rate
incidents of red blood cells, plasma, platelet and cryoprecipitate transfusions
the lowest postoperative hemoglobin value
the nadir hemoglobin value during one postoperative days
incidence of reoperation
incidence of reoperation due to postoperative bleeding
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Konkuk University Medical Center
Lead sponsor
Korea Health Industry Development Institute
Collaborator
Helptrial
Collaborator
Asan Medical Center
Collaborator
Samsung Medical Center
Collaborator
