RecruitingNot ApplicableNCT05806346

Goal-directed vs. Empirical Tranexamic Acid Administrationin Cardiovascular Surgery

Tranexamic Acid Administration Strategies in Cardiovascular Surgery: Goal-directed Tranexamic Acid Administration Based on Viscoelastic Test vs. Empirical Tranexamic Acid Administration


Sponsor

Konkuk University Medical Center

Enrollment

764 participants

Start Date

Aug 1, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 19 Years

Inclusion Criteria2

  • patients who will undergo elective cardiovascular surgery employing cardiopulmonary bypass
  • patients who provide written informed consent

Exclusion Criteria9

  • 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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Interventions

DRUGTXA administration

Tranexamic acid intravenous administration

DRUGPlacebo administration

Placebo (normal saline) intravenous administration


Locations(3)

Konkuk University Medical Center

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

Asan Medical Center

Seoul, South Korea

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NCT05806346


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