Trauma
Conditions
Brief summary
The objective of our study is to demonstrate the interest of early administration of recombinant erythropoietin in trauma patients
Detailed description
Could an early use of rHuEPO (recombinant Human ErythroPOietin ) be lead to an individual benefice on transfusion savings after traumatic surgery?
Interventions
OTHERrecombinant 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).
OTHERplacebo injection
Intravenous injection 0,9% saline solution.
Sponsors
Centre Hospitalier Universitaire de Nīmes
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Patients between 18 to 65 years old * 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 contraindication to synthetic erythropoietin * 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| number of administered red blood cells | Day 30 |
Countries
France
Outcome results
None listed