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

Last updated: May 12, 2024
Sponsor: Konkuk University Medical Center
Overall Status: Active - Recruiting

Phase

4

Condition

Digestive System Neoplasms

Prostate Cancer

Joint Injuries

Treatment

thromboelastography

Tranexamic Acid

TEG6

Clinical Study ID

NCT05957822
HI22C195200-1-1
  • Ages > 19
  • All Genders
  • Accepts Healthy Volunteers

Study 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 Criteria

Inclusion

Inclusion Criteria patients undergoing following surgery

  • spinal fusion surgery with more than 2 levels

  • total hip arthroplasty

  • total knee arthroplasty

  • open prostatectomy

  • hepatectomy

Exclusion

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 90days)

  • hypersensitive to TXA

  • histroy of convulsion or epilepsy

  • taking hemodialysis

  • history of Heparin-induced thrombocytopenia

Study Design

Total Participants: 148
Treatment Group(s): 5
Primary Treatment: thromboelastography
Phase: 4
Study Start date:
February 10, 2024
Estimated Completion Date:
January 01, 2025

Study 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.

Connect with a study center

  • Konkuk University Medical Center

    Seoul, 143-729
    Korea, Republic of

    Active - Recruiting

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