Goal-directed vs. Empirical Tranexamic Acid Administrationin Cardiovascular Surgery
Recruiting now · Not applicable · Has a placebo group
Conditions studied: Heart Diseases, Vascular Diseases, Transfusion Related Complication, Coagulation Disorder, Blood, Fibrinolysis; Hemorrhage
In brief
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.
Key facts
- Study ID
- NCT05806346
- Run by
- Konkuk University Medical Center
- People needed
- 764
- Starts
- 2023-08-01
- Expected to finish
- 2025-06-30
- Last updated by the study team
- 2024-12-18
Who can join
Age: 19 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- patients who will undergo elective cardiovascular surgery employing cardiopulmonary bypass
- patients who provide written informed consent
You may not qualify if…
- 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
Where it is running
- Konkuk University Medical Center — Seoul, South Korea (enrolling)
- Samsung Medical Center — Seoul, South Korea (enrolling)
- Asan Medical Center — Seoul, South Korea (enrolling)
Full record on ClinicalTrials.gov
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