NCT03044041CompletedPhase 4
Topical Intra-Articular High Doses Compared With Low Doses of Tranexamic Acid to Reduce Blood Loss in Primary Total Knee Arthroplasty: A Double-Blind Randomized Controlled Trial
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Thammasat University
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Total blood loss
Study Overview
Brief Summary
The purpose of this study is to compare blood loss between using low dose (500 mg) and high dose (3 g) topical intra-articular tranexamic acid after total knee arthroplasty in double-blind RCT
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 50 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Osteoarthritic knee who underwent primary total knee arthroplasty
Exclusion Criteria
- •Abnormal coagulation or bleeding disorder
- •Allergy to tranexamic acid
- •History of thromboembolism or ischemic heart disease or cerebrovascular accident
- •chronic kidney disease stage 3-4
Arms & Interventions
Low dose
Experimental
single dose of intra-articular Tranexamic acid 500 miligrams
Intervention: Tranexamic Acid (Drug)
High dose
Active Comparator
Single dose of intra-articular Tranexamic acid 3 grams
Intervention: Tranexamic Acid (Drug)
Outcomes
Primary Outcomes
Total blood loss
Time Frame: 72 hours after TKA
Blood loos that calculated from Haemoglobin drop at 72 hours after surgery
Secondary Outcomes
- Functional score(At 6 weeks after surgery)
- Rate of participants with infection(0-3 months after surgery)
- Blood transfusion(0-72 hours after surgery)
- Rate of participants with thromboembolism(At 72 hours and 2 weeks after surgery)
- Knee ROM(At 2, 6 weeks after surgery)
Investigators
Supakit Kanitnate
Investigator
Thammasat University
Study Sites (1)
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