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

Trauma Clinical Trial

— EPREX  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03867071
• Other study ID #: PHRCI/2004/AC-01
• Status: Completed
• Phase: N/A
• Start date: October 2005
• Est. completion date: July 2012

Study information

• Verified date: March 2019
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Trauma
• Wounds and Injuries

Intervention

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 injection
Intravenous injection 0,9% saline solution.

Locations

Country	Name	City	State
France	Nimes university hospital	Nîmes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of administered red blood cells		Day 30