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

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

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Key information

Conditions

Trauma Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nimes university hospital

Nîmes, 30029, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

recombinant erythropoietin injection

Other

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

Other

Intravenous injection 0,9% saline solution.

Primary outcomes

number of administered red blood cells

Time frame: Day 30

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Acronym: EPREX

Important dates

Study start: 2005
Primary completion: 2012
Study completion: 2012
First posted: Mar 7, 2019
Registry last updated: Mar 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed