NCT05806346

Goal-directed vs. Empirical Tranexamic Acid Administrationin Cardiovascular Surgery

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 764 (estimated)
• Sponsor: Konkuk University Medical Center · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not 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 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.

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 amounts of postoperative bleeding during postoperative 24 hours through chest tube drainage using two different tranexamic acid (TXA) administration strategies: empirical TXA administration vs. viscoelastic test-based goal-directed TXA administration in cardiovascular surgery. The secondary objectives include determining the inter-group differences in hyper-fibrinolysis, 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

• Heart Diseases
• Vascular Diseases
• Transfusion Related Complication
• Coagulation Disorder, Blood
• Fibrinolysis; Hemorrhage

Interventions

Type	Name	Description
DRUG	TXA administration	Tranexamic acid intravenous administration
DRUG	Placebo administration	Placebo (normal saline) intravenous administration

Timeline

• Start date: 2023-08-01
• Primary completion: 2025-04-30
• Completion: 2025-06-30
• First posted: 2023-04-10
• Last updated: 2024-12-18

Locations

3 sites across 1 country: South Korea