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Goal-directed vs. Empirical Tranexamic Acid Administrationin Cardiovascular Surgery

RecruitingNAAges 19 Years - anyAllKonkuk University Medical Center
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In plain words

What the trial is, and whether it could suit you

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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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * patients who will undergo elective cardiovascular surgery employing cardiopulmonary bypass * patients who provide written informed consent Exclusion Criteria: * pregnancy * refusal of allogenic blood transfusion * taking thrombin * history of thromboembolic and familial hypercoagulability disease * recent history of myocardial infarction or ischemic cerebral infarction (within 90 days) * hypersensitive to TXA * histroy of convulsion or epilepsy * taking hemodialysis * history of Heparin-induced thrombocytopenia
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What it tests

  • TXA administration
  • Placebo administration
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Where

3 sites
Konkuk University Medical Center
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
Asan Medical Center
Seoul, South Korea
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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