Arthritis of Hip
Conditions
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.
Interventions
DRUGTranexamic Acid
Tranexamic acid injection 10 mg/kg and infusion 2 mg/kg/hr
DIAGNOSTIC_TESTthromboelastography
thromboelastography (TEG6)
DRUGPlacebo
Normal saline injection
Sponsors
Konkuk University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Parallel Assignment randomized prospective double-blind placebo-controlled multicenter non-inferior
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CRT maximal amplitude | 24 hours | maximal amplitude of CRT test |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CK alpha angle | 24 hours | alpha angle of CRT test |
| CRT maximal lysis | 24 hours | maximal lysis of CRT test |
| CFF maximal amplitude | 24 hours | maximal amplitude of CFF test |
| Hemoglobin | 6 hours | the lowest hemoglobin value before transfusion |
| packed RBC | 6 hours | transfused fresh frozen plasma |
| fresh frozen plasma | 6 hours | transfused fresh frozen plasma |
| CK reaction time | 24 hours | r-time of CRT test |
| 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 |
| 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 |
| cryoprecipitate | 6 hours | transfused cryoprecipitate |
Countries
South Korea
Outcome results
None listed