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

Not Applicable

Completed

• Conditions: Trauma
• Interventions: Other: recombinant erythropoietin injection; Other: placebo injection

• Registration Number: NCT03867071
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

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?

Study Timeline

• Study Start: 2005-10
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Status Verified: 2019-03
• Study First Submitted: 2019-03-06
• Study First Submitted QC: 2019-03-06
• Last Update Submitted: 2019-03-06
• Study First Posted: 2019-03-07
• Last Update Posted: 2019-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
erythropoietin (EPO) group	recombinant erythropoietin injection	-
Placebo (PLA) group	placebo injection	-

Primary Outcome Measures

Name	Time	Method
number of administered red blood cells	Day 30

Trial Locations

Locations (1)

Nimes university hospital; 🇫🇷 Nîmes, France