NCT05957822

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

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 148 (estimated)
• Sponsor: Konkuk University Medical Center · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

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

Interventions

Type	Name	Description
DRUG	TXA	Tranexamic acid injection 8-10mg/kg
DIAGNOSTIC_TEST	TEG6	performing thromboelastography (TEG6)

Timeline

• Start date: 2024-02-10
• Primary completion: 2024-12-01
• Completion: 2025-01-01
• First posted: 2023-07-24
• Last updated: 2024-05-14

Locations

1 site across 1 country: South Korea