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

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

Study Overview

• Status: Completed
• Conditions: Trauma
• Intervention / Treatment: Other: recombinant erythropoietin injection; Other: placebo injection

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Nîmes, France, 30029
    • Nîmes University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: erythropoietin (EPO) group	Other: 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 Comparator: Placebo (PLA) group	Other: placebo injection; Intravenous injection 0,9% saline solution.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
number of administered red blood cells	Day 30

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2005
• Primary Completion (Actual): July 1, 2012
• Study Completion (Actual): July 1, 2012

Study Registration Dates

• First Submitted: March 6, 2019
• First Submitted That Met QC Criteria: March 6, 2019
• First Posted (Actual): March 7, 2019

Study Record Updates

• Last Update Posted (Actual): March 7, 2019
• Last Update Submitted That Met QC Criteria: March 6, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Hematinics; Epoetin Alfa
• Other Study ID Numbers: PHRCI/2004/AC-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No