Actively Recruiting
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
Eligibility Criteria
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
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
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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