Goal-directed vs Preemptive Tranexamic Acid Administration in Total Hip Arthroplasty

Study Overview
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Brief Summary
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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.

Official Title
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Comparison of TEG-guided and Preemptive Tranexamic Acid Administration Strategies in Total Hip Replacement Surgery

Conditions
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Arthritis of Hip

Intervention / Treatment
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* Drug: Tranexamic Acid
* Diagnostic Test: thromboelastography
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel Assignment randomized prospective double-blind placebo-controlled multicenter non-inferior
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Empirical 2: TXA administration<br>Tranexamic acid administration, regardless of the result of TEG6. | Drug: Tranexamic Acid<br>* Tranexamic acid injection 10 mg/kg and infusion 2 mg/kg/hr<br>Diagnostic Test: thromboelastography<br>* thromboelastography (TEG6)<br>|
| Experimental: Goal-directed 1: Placebo administration<br>Normal saline administration, according to the result of TEG6. . Placebo administration, at LY30 < 3% or MA > 54 mm in CRT of TEG6 | Diagnostic Test: thromboelastography<br>* thromboelastography (TEG6)<br>Drug: Placebo<br>* Normal saline injection<br>* Other names: Normal saline;|
| Experimental: Goal-directed 2: TXA administration<br>Tranexamic acid administration, according to the result of TEG6. Placebo discard, at LY30> 3% or MA<54 mm in CRT of TEG6 | Drug: Tranexamic Acid<br>* Tranexamic acid injection 10 mg/kg and infusion 2 mg/kg/hr<br>Diagnostic Test: thromboelastography<br>* thromboelastography (TEG6)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CRT maximal amplitude | maximal amplitude of CRT test | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CK reaction time | r-time of CRT test | 24 hours | 
| CK alpha angle | alpha angle of CRT test | 24 hours | 
| CRT maximal lysis | maximal lysis of CRT test | 24 hours | 
| CFF maximal amplitude | maximal amplitude of CFF test | 24 hours | 
| Hemoglobin | the lowest hemoglobin value before transfusion | 6 hours | 
| packed RBC | transfused fresh frozen plasma | 6 hours | 
| fresh frozen plasma | transfused fresh frozen plasma | 6 hours | 
| cryoprecipitate | transfused cryoprecipitate | 6 hours | 
| platelet | transfused platelet (apheresis) or platelet concentrate | 6 hours | 
| seizure | postoperative incidence of seizure | 48 hours | 
| thromboembolism | preoperative incidence of myocardial infarction, cerebral infarction, pulmonary thrombosis, intestinal infarction | 48 hours | 
| postoperative bleeding | bleeding from surgical drain | 48 hours | 
| re-operation | re-operation due to postoperative bleeding | 48 hours | 
| intraoperative bleeding | amount of intraoperative bleeding | 4 hours |