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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02650856 |
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Date of registration:
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29/12/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Blood Loss Reduction After Total Knee Arthroplasty. Comparison Topical Tranexamic Acid vs Platelet Rich Plasma
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Scientific title:
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Blood Loss Reduction After Total Knee Arthroplasty. A Comparison Between Topical Tranexamic Acid and Platelet Rich Plasma: Controlled Clinical Trial |
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Date of first enrolment:
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September 2015 |
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Target sample size:
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40 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02650856 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 3
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Countries of recruitment
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Mexico
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Contacts
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Name:
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Felix Vilchez, MD, PHD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hospital Universitario, Universidad Autonoma de Nuevo Leon |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Age >18 years
2. Patient candidates for primary total knee replacement
3. Patients willing to participate in the study and sign de inform consent
Exclusion Criteria:
1. Patients with previous history of thromboembolic event in the last 6 months
2. Patients candidates for revision total knee replacement
3. Patients candidates for tumoral total knee replacement
4. Patients candidates for bilateral total knee replacement
5. Patient with cognitive deficit
6. Previous history of coagulopathy
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Osteoarthritis
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Intervention(s)
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Biological: Group 2 Platelet rich plasma
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Drug: Group 1 Tranexamic Acid
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Primary Outcome(s)
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Therapeutic Effect on Hemoglobin Level
[Time Frame: up to 3rd day post operative (Baseline, 24, 48 and 72hrs)]
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Secondary Outcome(s)
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Therapeutic Effect on Drainage Quantification
[Time Frame: up to 2nd day post operative (24 and 48 hrs)]
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Therapeutic Effect on Hematocrit Level
[Time Frame: up to 3rd day post operative (Baseline, 24, 48 and 72hrs)]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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