TXA administration
DrugTranexamic acid intravenous administration
Other names: Tranexamic acid
NCT Number: NCT05806346
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.
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Request Info19 year and older
All sexes
Interventional
Not applicable
Asan Medical Center, Seoul, South Korea
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Tranexamic acid intravenous administration
Other names: Tranexamic acid
Placebo (normal saline) intravenous administration
Other names: Placebo (normal saline)
Time frame: 24 hours
bleeding amount though chest drainage tubes during the 1st postoperative 24 hour
Time frame: 24 hours
amounts of transfused red blood cells, plasma, platelet and cryoprecipitate
Time frame: 24 hours
incidents of red blood cells, plasma, platelet and cryoprecipitate transfusions
Time frame: 24 hours
the nadir hemoglobin value during one postoperative days
Time frame: 1 week
incidence of reoperation due to postoperative bleeding
Time frame: 1 hour
amounts of infused salvaged blood
Time frame: 1 hour
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 week
incidence of postoperative seizure till the hospital discharge
Time frame: 1 week
incidence of postoperative myocardia infarction, stroke, pulmonary embolism, gut infarction till the hospital discharge
Time frame: 1 week
duration of postoperative ventilatory care
Time frame: 1 week
duration of stay in the ICU and hospital
Time frame: 2 week
total expense paid at the discharge
Time frame: 1 week
incidence of taking hemodylaysis
Time frame: 1 week
diagnosed by KIDGO criteria
Time frame: 1 week
delirium digested by CAM-ICU
Time frame: 1 week
incidences of applying IABP, ECMO, VAD
Time frame: 1 week
hospital death
Time frame: 1 week
hemoglobin, platelet number, Prothrombin timeI activated partial thromboplastin timePTT , fibrinogen concentration, d-dimer
Contact information is provided by the study sponsor or research team.
Konkuk University Medical Center
Other
Tranexamic Acid Administration Strategies in Cardiovascular Surgery: Goal-directed Tranexamic Acid Administration Based on Viscoelastic Test vs. Empirical Tranexamic Acid Administration
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