Early Administration of Recombinant Erythropoietin (RHEPO) in Transfusion Savings in Trauma Patients
NCT ID: NCT03867071
Last Updated: 2019-03-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2005-10-31
2012-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
TRIPLE
Study Groups
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erythropoietin (EPO) group
recombinant erythropoietin injection
Intravenous injection of 300 international units (IU) per kg (kg) of recombinant erythropoietin with a maximum of 20.000 IU, daily for a maximum of 10 days (D0 to D9).
Placebo (PLA) group
placebo injection
Intravenous injection 0,9% saline solution.
Interventions
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recombinant erythropoietin injection
Intravenous injection of 300 international units (IU) per kg (kg) of recombinant erythropoietin with a maximum of 20.000 IU, daily for a maximum of 10 days (D0 to D9).
placebo injection
Intravenous injection 0,9% saline solution.
Eligibility Criteria
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Inclusion Criteria
* Patient with an ASA 1 or 2 (ASA 1 corresponding to a patient in perfect health and ASA 2 to a patient with moderate involvement and well controlled organ function)
* patient presenting at least one of the following fractures: Basin and / or femur with surgical indication, associated or not with other fractures.
* patient with hemoglobin between 9 and 13 g / dl at the time of admission on trauma department
Exclusion Criteria
* Patient with intravenous iron contraindication
* pregnant patient or with a risk of pregnancy
* patient who has not given his consent or does not understand the protocol
* Patient with hemodynamic instability
* patient participating in another research protocol for less than 3 months.
18 Years
65 Years
ALL
No
Sponsors
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Centre Hospitalier Universitaire de Nīmes
OTHER
Responsible Party
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Locations
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Nimes university hospital
Nîmes, , France
Countries
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Other Identifiers
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PHRCI/2004/AC-01
Identifier Type: -
Identifier Source: org_study_id
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