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.
The present study is a multi-center randomized prospective placebo-controlled non-inferiority trial. This study's primary objective is to compare the amounts of postoperative bleeding during postoperative 24 hours through chest tube drainage using two different tranexamic acid (TXA) administration strategies: empirical TXA administration vs. viscoelastic test-based goal-directed TXA administration in cardiovascular surgery. The secondary objectives include determining the inter-group differences in hyper-fibrinolysis, thromboembolic complications, and postoperative seizures. Researchers hypothesized that goal-directed TXA administration using viscoelastic field tests would not be inferior to the empirical TXA administration strategy in reducing postoperative bleeding and hyper-fibrinolysis. Researchers also expect that goal-directed TXA administration would be beneficial in lowering TXA-induced thromboembolic complications and seizure risks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
QUADRUPLE
Enrollment
764
Tranexamic acid intravenous administration
Placebo (normal saline) intravenous administration
Konkuk University Medical Center
Seoul, South Korea
RECRUITINGSamsung Medical Center
Seoul, South Korea
RECRUITINGAsan Medical Center
Seoul, South Korea
RECRUITINGpostoperative bleeding
bleeding amount though chest drainage tubes during the 1st postoperative 24 hour
Time frame: 24 hours
postoperative transfusion amount
amounts of transfused red blood cells, plasma, platelet and cryoprecipitate
Time frame: 24 hours
postoperative transfusion rate
incidents of red blood cells, plasma, platelet and cryoprecipitate transfusions
Time frame: 24 hours
the lowest postoperative hemoglobin value
the nadir hemoglobin value during one postoperative days
Time frame: 24 hours
incidence of reoperation
incidence of reoperation due to postoperative bleeding
Time frame: 1 week
amount of intraoperative cell salvage
amounts of infused salvaged blood
Time frame: 1 hour
viscoelastic whole blood profile
values of intraoperative CT-EXTEM, CFT-EXTEM, A10-EXTEM, MCF-EXTEM, ML-EXTEM, CT-FIBTEM, CFT-FIBTEM, A10-FIBTEM, MCF-FIBTEM, ML-FIBTEM in rotational thromboelastometry
Time frame: 1 hour
incidence of seizure
incidence of postoperative seizure till the hospital discharge
Time frame: 1 week
incidence of thromboembolic complications
incidence of postoperative myocardia infarction, stroke, pulmonary embolism, gut infarction till the hospital discharge
Time frame: 1 week
duration of mechanical ventilation
duration of postoperative ventilatory care
Time frame: 1 week
length of stays in the ICU and hospital
duration of stay in the ICU and hospital
Time frame: 1 week
total cost
total expense paid at the discharge
Time frame: 2 week
incidence of taking renal replacement therapy
incidence of taking hemodylaysis
Time frame: 1 week
incidence of acute kidney injury
diagnosed by KIDGO criteria
Time frame: 1 week
incidence of postoperative delirium
delirium digested by CAM-ICU
Time frame: 1 week
incidence of applying for mechanical circulatory support
incidences of applying IABP, ECMO, VAD
Time frame: 1 week
in-hospital mortality
hospital death
Time frame: 1 week
central laboratory blood tests
hemoglobin, platelet number, Prothrombin timeI activated partial thromboplastin timePTT , fibrinogen concentration, d-dimer
Time frame: 1 week
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