Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Empirical 2: TXA administration | Active Comparator | Tranexamic acid administration, regardless of the result of TEG6. |
|
| Goal-directed 1: Placebo administration | Experimental | 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 | Experimental | Tranexamic acid administration, according to the result of TEG6. Placebo discard, at LY30> 3% or MA<54 mm in CRT of TEG6 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic Acid | Drug | Tranexamic acid injection 10 mg/kg and infusion 2 mg/kg/hr |
|
| Measure | Description | Time Frame |
|---|---|---|
| CRT maximal amplitude | maximal amplitude of CRT test | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| CK reaction time | r-time of CRT test | 24 hours |
| CK alpha angle | alpha angle of CRT test | 24 hours |
Not provided
Inclusion Criteria:
Inclusion Criteria patients undergoing following surgery
- total hip arthroplasty
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Konkuk University Medical Center | Seoul | 143-729 | South Korea | |||
| Soi Lee |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D014148 | Tranexamic Acid |
| D013916 | Thrombelastography |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
Not provided
Not provided
Parallel Assignment randomized prospective double-blind placebo-controlled multicenter non-inferior
Not provided
Not provided
Not provided
| thromboelastography | Diagnostic Test | thromboelastography (TEG6) |
|
| Placebo | Drug | Normal saline injection |
|
|
| 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 |
| Seoul |
| South Korea |
| D001780 |
| Blood Coagulation Tests |
| D006403 | Hematologic Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |