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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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16 December 2017 |
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Main ID: |
NCT03019198 |
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Date of registration:
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10/01/2017 |
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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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TRANEXAMIC ACID IN PATIENTS UNDERGOING TOTAL HIP ARTHROPLASTY IN A BRAZILIAN REFERENCE ORTHOPEDIC CENTER: A RANDOMIZED CONTROLLED TRIAL
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Scientific title:
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TRANEXAMIC ACID IN PATIENTS UNDERGOING TOTAL HIP ARTHROPLASTY IN A BRAZILIAN REFERENCE ORTHOPEDIC CENTER: A RANDOMIZED CONTROLLED TRIAL |
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Date of first enrolment:
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December 2013 |
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Target sample size:
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256 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03019198 |
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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: Double (Participant, Care Provider).
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Phase:
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Phase 4
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Countries of recruitment
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Brazil
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Consecutive patients who need total hip replacement were included in the initial
sample. There was no age limit or restriction regarding gender for admission to the
study.
Exclusion Criteria:
- Patients who underwent previous surgery in the same joint, evidence of joint
infection, congenital or acquired coagulopathies, active intravascular coagulation,
acute occlusive vasculopathy, hypersensitivity to TXA, chronic use of oral and steroid
anticoagulants, history of severe or moderate allergy to plasma transfusion, chronic
heart disease, malignant neoplasms and autoimmune diseases, patients who needed bone
graft or underwent hip arthroplasty revision surgeries, and who did not consent to
participate in the study
Age minimum:
N/A
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Tranexamic Acid Adverse Reaction
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Blood Loss, Surgical
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Hip Replacement
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Intervention(s)
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Drug: Tranexamic Acid Injectable Solution
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Drug: Placebo - Concentrate
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Primary Outcome(s)
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Hematocrit drop
[Time Frame: 24 hours post operative]
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Operative blood loss
[Time Frame: 24 hours post operative]
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Blood transfusion rate
[Time Frame: 5 days]
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Hemoglobin drop
[Time Frame: 24 hours post operative]
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Secondary Outcome(s)
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Systemic adverse events
[Time Frame: 1 year]
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Length of stay in hospital
[Time Frame: 7 days]
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Thromboembolic efects
[Time Frame: 1 year]
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Secondary ID(s)
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06554913.0.0000.5273
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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