Actively Recruiting
Goal-directed vs. Empirical Tranexamic Acid Administrationin Cardiovascular Surgery
Led by Konkuk University Medical Center · Updated on 2024-12-18
764
Participants Needed
3
Research Sites
99 weeks
Total Duration
On this page
Sponsors
K
Konkuk University Medical Center
Lead Sponsor
K
Korea Health Industry Development Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Goal-directed vs. Empirical Tranexamic Acid Administrationin Cardiovascular Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients who will undergo elective cardiovascular surgery employing cardiopulmonary bypass
- Patients who provide written informed consent
You will not qualify if you...
- 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
- History of convulsion or epilepsy
- Taking hemodialysis
- History of Heparin-induced thrombocytopenia
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Trial Site Locations
Total: 3 locations
1
Konkuk University Medical Center
Seoul, South Korea, 05030
Actively Recruiting
2
Samsung Medical Center
Seoul, South Korea, 06351
Actively Recruiting
3
Asan Medical Center
Seoul, South Korea
Actively Recruiting
Research Team
T
Tae-Yop Kim, MD PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
4
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