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NCT05957822

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

Recruiting now Phase 4 Last updated 14 May 2024
What this trial tests

Phase 4 trial testing TXA in Arthritis Knee in 148 participants. Currently enrolling.

Timeline
10 February 2024
Primary endpoint
1 December 2024
1 January 2025

Quick facts

Lead sponsorKonkuk University Medical Center
PhasePhase 4
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment148
Start date10 February 2024
Primary completion1 December 2024
Estimated completion1 January 2025
Sites1 location across South Korea

Drugs / interventions tested

Conditions studied

Sponsor

Konkuk University Medical Center

Who can join

19 and older, any sex, with Arthritis Knee or Spine Fusion. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Viscoelastic haemostatic assays to guide therapy in elective surgery: an updated systematic review and meta-analysis.
    Dias JD, Levy JH, Tanaka KA, Zacharowski K, et al · · 2025 · cited 6× · PMID 39544008 · DOI 10.1111/anae.16463

Verify or expand the search:

Other trials of TXA

Trials testing the same drug.

Other recruiting trials for Arthritis Knee

Currently open trials in the same condition.

Other Konkuk University Medical Center trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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