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

Prostate Cancer Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

The present study is a multi-center randomized prospective placebo-controlled non-inferiority trial. This 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 non-cardiac surgery. The secondary objectives include determining the inter-group differences in hyper-fibrinolysis, during postoperative 2bleeding, thromboembolic complications, and postoperative seizures. Researchers hypothesized that goal-directed TXA administration using viscoelastic field tests would not be inferior to the empirical TXA administration strategy in reducing postoperative bleeding and hyper-fibrinolysis. Researchers also expect that goal-directed TXA administration would be beneficial in lowering TXA-induced thromboembolic complications and seizure risks. ;

Related Conditions & MeSH terms

• Arthritis
• Arthritis Knee
• Arthritis of Hip
• Hepatic Cancer
• Liver Neoplasms
• Prostate Cancer
• Spine Fusion

• NCT number: NCT05957822
• Study type: Interventional
• Source: Konkuk University Medical Center
• Contact: Tae-Yop Kim
• Phone: +82 10 8811 6942
• Email: taeyop@gmail.com
• Status: Recruiting
• Phase: Phase 4
• Start date: February 10, 2024
• Completion date: January 1, 2025