Comparing two methods of tranexamic acid administration in heart surgery
Tranexamic Acid Administration Strategies in Cardiovascular Surgery: Goal-directed Tranexamic Acid Administration Based on Viscoelastic Test vs. Empirical Tranexamic Acid Administration
This study is testing two different ways to give a medication during heart surgery to see which method helps reduce bleeding and complications after the surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 764 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Konkuk University Medical Center Academic / other |
| Locations | 3 sites (Seoul and 2 other locations) |
| Trial ID | NCT05806346 on ClinicalTrials.gov |
What this trial studies
This multi-center randomized prospective placebo-controlled trial aims to evaluate the effectiveness of two different strategies for administering tranexamic acid (TXA) during cardiovascular surgery. One group will receive empirical TXA administration, while the other will receive goal-directed TXA based on viscoelastic tests. The primary focus is to assess postoperative bleeding through chest tube drainage over 24 hours, with secondary objectives including the incidence of hyper-fibrinolysis, thromboembolic complications, and postoperative seizures. Researchers hypothesize that the goal-directed approach will not only be as effective as the empirical method but may also reduce complications associated with TXA.
Who should consider this trial
Good fit: Ideal candidates include patients scheduled for elective cardiovascular surgery that requires cardiopulmonary bypass.
Not a fit: Patients who are pregnant, have a history of thromboembolic disorders, or refuse allogenic blood transfusions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management of bleeding in cardiovascular surgery, enhancing patient outcomes and safety.
How similar studies have performed: Previous studies have shown promise in using goal-directed approaches in surgical settings, suggesting potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion 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 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 this trial is running
Seoul and 2 other locations
- Konkuk University Medical Center — Seoul, South Korea (Recruiting)
- Samsung Medical Center — Seoul, South Korea (Recruiting)
- Asan Medical Center — Seoul, South Korea (Recruiting)
Study contacts
- Principal investigator: Tae-Yop Kim, MD, PhD — Konkuk University Medical Center
- Study coordinator: Tae-Yop Kim, MD PhD
- Email: taeyop@gmail.com
- Phone: +82-10-8811-6942
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.