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Trial Title:
Goal-directed vs Preemptive Tranexamic Acid Administration in Non-cardiac Surgery
NCT ID:
NCT05957822
Condition:
Arthritis Knee
Spine Fusion
Prostate Cancer
Arthritis of Hip
Hepatic Cancer
Conditions: Official terms:
Liver Neoplasms
Arthritis
Conditions: Keywords:
bleeding
viscoelastic test
tranexamic acid
transfusion
thromboembolism
fibrinolysis
seizure
Study type:
Interventional
Study phase:
Phase 4
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
randomized prospective multicenter non-inferior
Primary purpose:
Treatment
Masking:
Double (Participant, Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
TXA
Description:
Tranexamic acid injection 8-10mg/kg
Arm group label:
TXA TEG6-triggered
Arm group label:
TXA empirical
Other name:
TXA administration
Intervention type:
Diagnostic Test
Intervention name:
TEG6
Description:
performing thromboelastography (TEG6)
Arm group label:
TXA TEG6-non-triggered
Arm group label:
TXA TEG6-triggered
Other name:
thromboelastography 6
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.
Detailed 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.
Criteria for eligibility:
Criteria:
Inclusion Criteria patients undergoing following surgery
- spinal fusion surgery with more than 2 levels
- total hip arthroplasty
- total knee arthroplasty
- open prostatectomy
- hepatectomy
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 90
days)
- hypersensitive to TXA
- histroy of convulsion or epilepsy
- taking hemodialysis
- history of Heparin-induced thrombocytopenia
Gender:
All
Minimum age:
19 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Konkuk University Medical Center
Address:
City:
Seoul
Zip:
143-729
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Tae-yop Kim, M.D, PhD
Email:
taeyop@gmail.com
Investigator:
Last name:
Tae-Yop Kim, MD PhD
Email:
Principal Investigator
Start date:
February 10, 2024
Completion date:
January 1, 2025
Lead sponsor:
Agency:
Konkuk University Medical Center
Agency class:
Other
Collaborator:
Agency:
Korea Health Industry Development Institute
Agency class:
Other
Collaborator:
Agency:
Asan Medical Center
Agency class:
Other
Collaborator:
Agency:
Soon Chun Hyang University
Agency class:
Other
Source:
Konkuk University Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05957822
