RecruitingPhase 4NCT05957822

Goal-directed vs Preemptive Tranexamic Acid Administration in Non-cardiac Surgery

Comparison of Viscoelastic Test-guided and Preemptive Tranexamic Acid Administration Strategies in High-risk Non-cardiac Surgery

Sponsor

Konkuk University Medical Center

Enrollment

148 participants

Start Date

Feb 10, 2024

Study Type

INTERVENTIONAL

Conditions

Prostate Cancer Arthritis Knee Spine Fusion Arthritis of Hip Hepatic Cancer

Summary

The present study is a multi-center randomized prospective non-inferiority trial. The study's primary objective is to compare the coagulation profile upon using two different TXA administration strategies: empirical TXA administration vs. viscoelastic test-based goal-directed TXA administration in high-risk non-cardiac surgery. The secondary objectives include comparing the amount of bleeding, 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.

Eligibility

Min Age: 19 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two approaches to giving tranexamic acid — a medication that reduces bleeding — during major surgeries. Researchers want to find out whether giving it based on real-time monitoring (goal-directed) is better or safer than giving it preventively (preemptive) in reducing blood loss and transfusions. **You may be eligible if...** - You are scheduled for one of the following surgeries: spinal fusion of more than 2 levels, total hip replacement, total knee replacement, open prostatectomy, or liver resection **You may NOT be eligible if...** - You are pregnant - You refuse blood transfusions - You are currently on blood-thinning (thrombin) medication - You have a history of blood clots or a hereditary clotting disorder - You had a heart attack or stroke within the past 90 days - You are allergic to tranexamic acid - You have a history of seizures or epilepsy - You are on dialysis or have a history of heparin-induced low platelet count Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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