Tranexamic Acid Administration Strategies in Cardiovascular Surgery: Goal-directed vs. Empirical Tranexamic Acid Administration

• Status: Not yet recruiting
• Trial end date: 2024-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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 reducing TXA-induced thromboembolic complications and seizures.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Konkuk University Medical Center
• Collaborators: Asan Medical Center; Helptrial; Korea Health Industry Development Institute; Samsung Medical Center
• Treatments: Tranexamic Acid

Criteria

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 coagulation disorder

• 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