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
Konkuk University Medical Center
148 participants
Feb 10, 2024
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria5
- spinal fusion surgery with more than 2 levels
- total hip arthroplasty
- total knee arthroplasty
- open prostatectomy
- hepatectomy
Exclusion Criteria9
- 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
Interventions
Tranexamic acid injection 8-10mg/kg
performing thromboelastography (TEG6)
Locations(1)
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NCT05957822