drugset / Trial / NCT05957822

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

NCT05957822 ↗

RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2024-02-10
Primary completion
2024-12-01
Completion
2025-01-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Tranexamic Acid Small molecule 8 mg/kg —
Subject Tranexamic Acid Small molecule 10 mg/kg —