Overview
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.
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.
Eligibility
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