Early Administration of Recombinant Erythropoietin (RHEPO) in Transfusion Savings in Trauma Patients (EPREX)

Centre Hospitalier Universitaire de Nīmes

Status: Completed

Conditions: Trauma

Treatments: Other: recombinant erythropoietin injection; Other: placebo injection

Study type: Interventional

Funder types: Other

Identifiers

NCT03867071

PHRCI/2004/AC-01

Details and patient eligibility

About

The objective of our study is to demonstrate the interest of early administration of recombinant erythropoietin in trauma patients

Full description

Could an early use of rHuEPO (recombinant Human ErythroPOietin ) be lead to an individual benefice on transfusion savings after traumatic surgery?

Enrollment: 60 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups, including a placebo group

erythropoietin (EPO) group

Experimental group

Treatment:

Other: recombinant erythropoietin injection

Placebo (PLA) group

Placebo Comparator group

Treatment:

Other: placebo injection