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Tranexamic Acid in Revision Total Joint Arthroplasty: A Prospective Randomized Controlled Trial
To determine the optimal dosing regimen and route of administration of tranexamic acid (TXA) \[single dose intravenous (IV), double dose intravenous, intravenous + topical, and oral repeated dosing\] to minimize post-operative blood loss and transfusion requirements following revision total knee arthroplasty (RTKA).
Details
| Lead sponsor | Rush University Medical Center |
|---|---|
| Phase | Phase 4 |
| Status | COMPLETED |
| Enrolment | 175 |
| Start date | 2016-04 |
| Completion | 2019-08-01 |
Conditions
- Revision Total Knee Arthroplasty
- Revision Total Hip Arthroplasty
- Acute Blood Loss Anemia
Interventions
- Revision Total Knee Arthroplasty (TKA)
- Revision Total Hip Arthroplasty (THA)
Primary outcomes
- Post-operative reduction in Hemoglobin — Post-operative and before discharge from hospital (inpatient), < 30 days from surgery
Pre-operative hemoglobin minus the lowest post-operative hemoglobin prior to any transfusion - Post-operative reduction in Hematocrit — Post-operative and before discharge from hospital (inpatient), < 30 days from surgery
Pre-operative hematocrit minus the lowest post-operative hematocrit prior to any transfusion - Calculated blood loss — Post-operative and before discharge from hospital (inpatient), < 30 days from surgery
Based on predicted blood volume and hemoglobin balance - Number of units transfused — Post-operative and before discharge from hospital (inpatient), < 30 days from surgery
per patient - Number of Patients Transfused — Post-operative and before discharge from hospital (inpatient), < 30 days from surgery
Countries
United States