Phase 3
N=40
Blood Loss Reduction After Total Knee Arthroplasty. Comparison Topical Tranexamic Acid vs Platelet Rich Plasma
Osteoarthritis
Bottom Line
View on ClinicalTrials.gov: NCT02650856 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Feb 2020
Primary outcome: Primary: Therapeutic Effect on Hemoglobin Level — 13.6; 13.6; 10.3; 9.9 g/dL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Group 1 Tranexamic Acid (Drug); Group 2 Platelet rich plasma (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Universidad Autonoma de Nuevo Leon
- Primary completion
- Mar 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Therapeutic Effect on Hemoglobin Level |
13.6; 13.6; 10.3; 9.9; 9.5; 9.2 | — |
| SECONDARY Therapeutic Effect on Hematocrit Level |
41.7; 41.5; 31.6; 29.8; 29.1; 27.7 | — |
| SECONDARY Therapeutic Effect on Drainage Quantification |
246.4; 263.2; 120.8; 140.2 | — |
Summary
The investigators will include patients who will be schedule for total knee arthroplasty with a diagnosis of osteoarthritis. The patients will be divided in two groups. In both groups a verbal and clear detailed information will be given on the intraoperative approach. The first group will receive topical tranexamic acid and the second group topical platelet rich plasma; both in the surgical site. Both groups will be assessed before and after the intervention with laboratory results (hemoglobin, hematocrit levels) and drainage drain.
Eligibility Criteria
Inclusion Criteria
- Age >18 years
- Patient candidates for primary total knee replacement
- Patients willing to participate in the study and sign de inform consent
Exclusion Criteria
- Patients with previous history of thromboembolic event in the last 6 months
- Patients candidates for revision total knee replacement
- Patients candidates for tumoral total knee replacement
- Patients candidates for bilateral total knee replacement
- Patient with cognitive deficit
- Previous history of coagulopathy
Data sourced from ClinicalTrials.gov (NCT02650856). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.