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

• Status: Recruiting
• Trial end date: 2025-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Konkuk University Medical Center
• Collaborators: Asan Medical Center; Korea Health Industry Development Institute; Soon Chun Hyang University

Criteria

Inclusion Criteria patients undergoing following surgery

• spinal fusion surgery with more than 2 levels

• total hip arthroplasty

• total knee arthroplasty

• open prostatectomy

• hepatectomy

Exclusion Criteria:

• pregnancy

• refusal of allogenic blood transfusion

• taking thrombin

• history of thromboembolic and familial hypercoagulability disease

• recent history of myocardial infarction or ischemic cerebral infarction (within 90 days)

• hypersensitive to TXA

• histroy of convulsion or epilepsy

• taking hemodialysis

• history of Heparin-induced thrombocytopenia