RecruitingNot ApplicableNCT05806346

Goal-directed vs. Empirical Tranexamic Acid Administrationin Cardiovascular Surgery

Tranexamic Acid Administration Strategies in Cardiovascular Surgery: Goal-directed Tranexamic Acid Administration Based on Viscoelastic Test vs. Empirical Tranexamic Acid Administration


Sponsor

Konkuk University Medical Center

Enrollment

764 participants

Start Date

Aug 1, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 19 Years

Plain Language Summary

Simplified for easier understanding

This study compares two ways of using tranexamic acid (TXA) — a medication that reduces bleeding — during cardiovascular surgery requiring cardiopulmonary bypass. The first approach is empirical (giving a standard dose based on body weight to everyone), and the second is goal-directed (using real-time blood clotting tests to personalize the dose for each individual patient). Excessive bleeding during heart surgery remains a major cause of complications and blood transfusions, and tailoring TXA dosing may improve both safety and effectiveness. Adults aged 19 and over scheduled for elective cardiovascular surgery using a heart-lung bypass machine, who provide written consent, are eligible. Those who are pregnant, refuse blood transfusions, have a history of blood clots or coagulation disorders, recent heart attack or stroke, allergy to TXA, or are on dialysis are excluded. Blood loss is a major challenge in cardiac surgery — it contributes to complications including organ failure, prolonged ICU stays, and the need for blood transfusions, which carry their own risks. Personalized dosing of antifibrinolytic drugs like TXA has the potential to optimize bleeding control while minimizing side effects like clot formation. This study aims to determine whether tailoring the dose in real time — guided by point-of-care testing — produces better outcomes than the standard one-size-fits-all approach.

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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Interventions

DRUGTXA administration

Tranexamic acid intravenous administration

DRUGPlacebo administration

Placebo (normal saline) intravenous administration


Locations(3)

Konkuk University Medical Center

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

Asan Medical Center

Seoul, South Korea

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NCT05806346


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