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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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15 April 2024 |
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Main ID: |
NCT03113253 |
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Date of registration:
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10/04/2017 |
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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 to Reduce Bleeding in BURN Surgery
TRANBURN |
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Scientific title:
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The Effect of Tranexamic Acid (TXA) on Blood Loss in Burn Surgery - A Randomized, Double-Blinded Placebo-Controlled Trial |
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Date of first enrolment:
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September 22, 2016 |
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Target sample size:
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121 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT03113253 |
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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: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 4
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Countries of recruitment
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France
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Contacts
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Name:
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Mathieu Fontaine, 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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Saint Joseph Saint Luc Hospital, Burn Intensive Care Unit |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Subjects undergoing burn excision surgery for standard of care purposes
- Male or female >= 18 years of age
- Subject or subject's medical decision maker agrees to participate in this study and
provides informed consent
Exclusion Criteria:
- Subjects with a history of hypercoagulopathy, deep vein thrombosis (DVT), pulmonary
embolism
- Renal impairment
- Subjects with known hypersensitivity to tranexamic acid
- Consecutive fibrinolytic states to coagulopathy
- History of convulsions
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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Wounds and Injuries
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Surgery
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Burns
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Tranexamic Acid
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Intervention(s)
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Drug: Placebo
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Drug: Tranexamic Acid
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Primary Outcome(s)
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Blood loss (mL / cm² excised)
[Time Frame: Until day 5 post surgery]
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Secondary Outcome(s)
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All-cause Hospital Mortality
[Time Frame: Until day 15 post surgery]
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Stroke
[Time Frame: Until day 15 post surgery]
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Myocardial infarction
[Time Frame: Until day 15 post surgery]
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Deep vein thrombosis
[Time Frame: Until day 15 post surgery]
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Need for transfusion
[Time Frame: Until day 5 post surgery]
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Pulmonary embolism
[Time Frame: Until day 15 post surgery]
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Convulsion
[Time Frame: Until day 15 post surgery]
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Success of skin graft
[Time Frame: Until day 15 post surgery]
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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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