Actively Recruiting

Phase 4
Age: 19Years +
All Genders
Healthy Volunteers
NCT05957822

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

Led by Konkuk University Medical Center · Updated on 2024-05-14

148

Participants Needed

1

Research Sites

46 weeks

Total Duration

On this page

Sponsors

K

Konkuk University Medical Center

Lead Sponsor

K

Korea Health Industry Development Institute

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 19Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Undergoing spinal fusion surgery with more than 2 levels
  • Undergoing total hip arthroplasty
  • Undergoing total knee arthroplasty
  • Undergoing open prostatectomy
  • Undergoing hepatectomy
Not Eligible

You will not qualify if you...

  • Pregnancy
  • Refusal of allogenic blood transfusion
  • Taking thrombin
  • History of thromboembolic and familial hypercoagulability disease
  • Recent myocardial infarction or ischemic cerebral infarction within 90 days
  • Hypersensitivity to tranexamic acid
  • History of convulsion or epilepsy
  • Receiving hemodialysis
  • History of heparin-induced thrombocytopenia

AI-Screening

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Trial Site Locations

Total: 1 location

1

Konkuk University Medical Center

Seoul, South Korea, 143-729

Actively Recruiting

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Research Team

T

Tae-Yop Kim

CONTACT

W

Wooseul Lee

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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