NCT05956769

Goal-directed vs Preemptive Tranexamic Acid Administration in Total Hip Arthroplasty

Comparison of TEG-guided and Preemptive Tranexamic Acid Administration Strategies in Total Hip Replacement Surgery

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 84 (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 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 vs Preemptive Tranexamic Acid Administration in total hip arthroplasty. 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.

Conditions

• Arthritis of Hip

Interventions

Type	Name	Description
DRUG	Tranexamic Acid	Tranexamic acid injection 10 mg/kg and infusion 2 mg/kg/hr
DIAGNOSTIC_TEST	thromboelastography	thromboelastography (TEG6)
DRUG	Placebo	Normal saline injection

Timeline

• Start date: 2024-02-01
• Primary completion: 2024-11-30
• Completion: 2024-12-31
• First posted: 2023-07-21
• Last updated: 2024-01-02

Locations

2 sites across 1 country: South Korea