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RECRUITING
NCT05806346
NA

Goal-directed vs. Empirical Tranexamic Acid Administrationin Cardiovascular Surgery

Sponsor: Konkuk University Medical Center

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

19 Years - Any

Study Type

INTERVENTIONAL

Enrollment

764

Start Date

2023-08-01

Completion Date

2025-06-30

Last Updated

2024-12-18

Healthy Volunteers

No

Interventions

DRUG

TXA administration

Tranexamic acid intravenous administration

DRUG

Placebo 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