Comparison of TEG-guided and Preemptive Tranexamic Acid Administration Strategies in Total Hip Replacement Surgery
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 84
- Locations
- 2
- Primary Endpoint
- CRT maximal amplitude
Overview
Brief Summary
The present study is a multi-center randomized prospective placebo-controlled non-inferiority trial. The study's primary objective is to compare the amounts of postoperative bleeding using two different TXA administration strategies: empirical TXA administration vs. viscoelastic test-based Goal-directed vs Preemptive Tranexamic Acid Administration in total hip arthroplasty. The secondary objectives include comparing the 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 19 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Inclusion Criteria patients undergoing following surgery
- •total hip arthroplasty
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
Arms & Interventions
Empirical 2: TXA administration
Tranexamic acid administration, regardless of the result of TEG6.
Intervention: Tranexamic Acid (Drug)
Empirical 2: TXA administration
Tranexamic acid administration, regardless of the result of TEG6.
Intervention: thromboelastography (Diagnostic Test)
Goal-directed 1: Placebo administration
Normal saline administration, according to the result of TEG6. . Placebo administration, at LY30 < 3% or MA > 54 mm in CRT of TEG6
Intervention: thromboelastography (Diagnostic Test)
Goal-directed 1: Placebo administration
Normal saline administration, according to the result of TEG6. . Placebo administration, at LY30 < 3% or MA > 54 mm in CRT of TEG6
Intervention: Placebo (Drug)
Goal-directed 2: TXA administration
Tranexamic acid administration, according to the result of TEG6. Placebo discard, at LY30> 3% or MA<54 mm in CRT of TEG6
Intervention: Tranexamic Acid (Drug)
Goal-directed 2: TXA administration
Tranexamic acid administration, according to the result of TEG6. Placebo discard, at LY30> 3% or MA<54 mm in CRT of TEG6
Intervention: thromboelastography (Diagnostic Test)
Outcomes
Primary Outcomes
CRT maximal amplitude
Time Frame: 24 hours
maximal amplitude of CRT test
Secondary Outcomes
- intraoperative bleeding(4 hours)
- CK reaction time(24 hours)
- CRT maximal lysis(24 hours)
- Hemoglobin(6 hours)
- packed RBC(6 hours)
- postoperative bleeding(48 hours)
- re-operation(48 hours)
- CK alpha angle(24 hours)
- CFF maximal amplitude(24 hours)
- fresh frozen plasma(6 hours)
- cryoprecipitate(6 hours)
- platelet(6 hours)
- seizure(48 hours)
- thromboembolism(48 hours)
Investigators
Tae-Yop Kim, MD PhD
Professor of Anesthesiology
Konkuk University Medical Center