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

RECRUITINGPhase 4Sponsored by Konkuk University Medical Center
Actively Recruiting
PhasePhase 4
SponsorKonkuk University Medical Center
Started2024-02-10
Est. completion2024-12-01
Eligibility
Age19 Years+
Healthy vol.Accepted

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

Age: 19 Years+Healthy volunteers accepted
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

Conditions10

ArthritisArthritis KneeArthritis of HipCancerHeart DiseaseHepatic CancerLiver CancerLiver DiseaseProstate CancerSpine Fusion

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