Combined Administration of Intravenous and Topical Tranexamic Acid in Total Knee Arthroplasty: Is it the Most Effective Regime? A Randomized Controlled Trial.
Overview
- Phase
- Phase 1
- Intervention
- Tranexamic Acid
- Conditions
- Degenerative Arthritis
- Sponsor
- Seoul National University Hospital
- Enrollment
- 264
- Primary Endpoint
- Change in Hemoglobin
- Last Updated
- 11 years ago
Overview
Brief Summary
This prospective randomized controlled trial was conducted To compare the efficacy of TNA in terms of total blood loss and the allogenic transfusion rate among the three study groups; intravenous alone, combined intravenous and low dose topical TNA and combined intravenous and high dose topical TNA.
To evaluate the safety of each regimen in view of deep vein thrombosis and venous thromboembolism.
Investigators
Tae Kyun Kim
Director, Clinical Research
Seoul National University Hospital
Eligibility Criteria
Inclusion Criteria
- •patients with diagnosis of primary osteoarthritis
Exclusion Criteria
- •patients with diagnoses other than primary OA
- •patients on anticoagulation therapy
- •patient with chronic renal failure
- •patient with CVA Hx
- •Patient with seizure Hx
- •Patient with severe CHF
- •Patient with acquired or congenital coagulopathy
Arms & Interventions
Only Intravenous Group
Only Intravenous Injection During Operation, 10mg/kr
Intervention: Tranexamic Acid
Intravenous + Topical 1g Group
Intravenous Injection During Operation, 10mg/kr After Capsule Closure, Tranexamic acid Topical Injection 1g
Intervention: Tranexamic Acid
Intravenous + Topical 2g Group
Intravenous Injection During Operation, 10mg/kr After Capsule Closure, Tranexamic acid Topical Injection 2g
Intervention: Tranexamic Acid
No Intravenous, Only Topical 2g Group
Only Topical Injection 2g
Intervention: Tranexamic Acid
Outcomes
Primary Outcomes
Change in Hemoglobin
Time Frame: baseline and 5 days
Blood loss reduce