Comparison of Viscoelastic Test-guided and Preemptive Tranexamic Acid Administration Strategies in High-risk Non-cardiac Surgery

Status: Recruiting
Location: See location...
Intervention Type: Drug, Diagnostic test
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 19
Healthy Volunteers: t
View:

• spinal fusion surgery with more than 2 levels

• total hip arthroplasty

• total knee arthroplasty

• open prostatectomy

• hepatectomy

Locations
Other Locations
Republic of Korea
Konkuk University Medical Center
RECRUITING
Seoul
Contact Information
Primary
Tae-Yop Kim
taeyop@gmail.com
+82 10 8811 6942
Backup
Wooseul Lee
wslee.kku@gmail.com
+82 10 8805 5661
Time Frame
Start Date: 2024-02-10
Estimated Completion Date: 2025-01-01
Participants
Target number of participants: 148
Treatments
Active_comparator: TXA empirical
Empirical Tranexamic acid (TXA) administration after the anesthesia induction
Experimental: TXA TEG6-triggered
When LY30≥3% or MA\<54 mm in CRT of TEG6, Tranexamic acid (TXA) is administered
Experimental: TXA TEG6-non-triggered
When LY30\<3% or MA ≥ 54 mm in CRT of TEG6, Tranexamic acid (TXA) is not administered
Sponsors
Collaborators: Asan Medical Center, Korea Health Industry Development Institute, Soon Chun Hyang University
Leads: Konkuk University Medical Center

This content was sourced from clinicaltrials.gov