Comparing two methods of administering tranexamic acid in non-cardiac surgeries
Comparison of Viscoelastic Test-guided and Preemptive Tranexamic Acid Administration Strategies in High-risk Non-cardiac Surgery
This study is testing two ways to give a medication called tranexamic acid to see which method works better in reducing bleeding and other complications during high-risk non-cardiac surgeries.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 148 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Konkuk University Medical Center Academic / other |
| Locations | 1 site (Seoul) |
| Trial ID | NCT05957822 on ClinicalTrials.gov |
What this trial studies
This multi-center randomized prospective trial aims to evaluate the effectiveness of two different strategies for administering tranexamic acid (TXA) in high-risk non-cardiac surgeries. One group will receive empirical TXA administration, while the other will receive TXA based on viscoelastic test results. The study will assess outcomes such as bleeding, hyper-fibrinolysis, thromboembolic complications, and postoperative seizures. Researchers hypothesize that the goal-directed approach will not be inferior to the empirical method in reducing these complications.
Who should consider this trial
Good fit: Ideal candidates include patients scheduled for spinal fusion, total hip or knee arthroplasty, open prostatectomy, or hepatectomy.
Not a fit: Patients who are pregnant, refuse blood transfusions, or have a history of thromboembolic diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management of bleeding and reduced complications in patients undergoing high-risk surgeries.
How similar studies have performed: Previous studies have shown promising results with goal-directed TXA administration, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria patients undergoing following surgery * spinal fusion surgery with more than 2 levels * total hip arthroplasty * total knee arthroplasty * open prostatectomy * hepatectomy 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
- Konkuk University Medical Center — Seoul, South Korea (Recruiting)
Study contacts
- Principal investigator: Tae-Yop Kim, MD, PhD — Konkuk University Medical Center
- Study coordinator: Tae-Yop Kim
- 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.