Goal-directed vs Preemptive Tranexamic Acid Administration in Total Hip Arthroplasty
- Conditions
- Arthritis of Hip
- Interventions
- Registration Number
- NCT05956769
- Lead Sponsor
- Konkuk University Medical Center
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 84
Inclusion Criteria patients undergoing following surgery
- total hip arthroplasty
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Goal-directed 1: Placebo administration Placebo Normal saline administration, according to the result of TEG6. . Placebo administration, at LY30 \< 3% or MA \> 54 mm in CRT of TEG6 Goal-directed 2: TXA administration Tranexamic Acid Tranexamic acid administration, according to the result of TEG6. Placebo discard, at LY30\> 3% or MA\<54 mm in CRT of TEG6 Empirical 2: TXA administration Tranexamic Acid Tranexamic acid administration, regardless of the result of TEG6. Empirical 2: TXA administration thromboelastography Tranexamic acid administration, regardless of the result of TEG6. Goal-directed 1: Placebo administration thromboelastography Normal saline administration, according to the result of TEG6. . Placebo administration, at LY30 \< 3% or MA \> 54 mm in CRT of TEG6 Goal-directed 2: TXA administration thromboelastography Tranexamic acid administration, according to the result of TEG6. Placebo discard, at LY30\> 3% or MA\<54 mm in CRT of TEG6
- Primary Outcome Measures
Name Time Method CRT maximal amplitude 24 hours maximal amplitude of CRT test
- Secondary Outcome Measures
Name Time Method CK reaction time 24 hours r-time of CRT test
CRT maximal lysis 24 hours maximal lysis of CRT test
Hemoglobin 6 hours the lowest hemoglobin value before transfusion
packed RBC 6 hours transfused fresh frozen plasma
postoperative bleeding 48 hours bleeding from surgical drain
re-operation 48 hours re-operation due to postoperative bleeding
intraoperative bleeding 4 hours amount of intraoperative bleeding
CK alpha angle 24 hours alpha angle of CRT test
CFF maximal amplitude 24 hours maximal amplitude of CFF test
fresh frozen plasma 6 hours transfused fresh frozen plasma
cryoprecipitate 6 hours transfused cryoprecipitate
platelet 6 hours transfused platelet (apheresis) or platelet concentrate
seizure 48 hours postoperative incidence of seizure
thromboembolism 48 hours preoperative incidence of myocardial infarction, cerebral infarction, pulmonary thrombosis, intestinal infarction
Trial Locations
- Locations (2)
Soi Lee
🇰🇷Seoul, Korea, Republic of
Konkuk University Medical Center
🇰🇷Seoul, Korea, Republic of