RecruitingPhase 4NCT05957822

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


Sponsor

Konkuk University Medical Center

Enrollment

148 participants

Start Date

Feb 10, 2024

Study Type

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

Min Age: 19 Years

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

DRUGTXA

Tranexamic acid injection 8-10mg/kg

DIAGNOSTIC_TESTTEG6

performing thromboelastography (TEG6)


Locations(1)

Konkuk University Medical Center

Seoul, South Korea

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NCT05957822


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