Trial | NCT03867071  Report issue

Official Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    60
The objective of our study is to demonstrate the interest of early administration of recombinant erythropoietin in trauma patients
Could an early use of rHuEPO (recombinant Human ErythroPOietin ) be lead to an individual benefice on transfusion savings after traumatic surgery?
Study Started
Oct 31
2005
Primary Completion
Jul 31
2012
Study Completion
Jul 31
2012
Last Update
Mar 07
2019

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).

Other placebo injection

Intravenous injection 0,9% saline solution.

erythropoietin (EPO) group Experimental

Placebo (PLA) group Placebo Comparator

Criteria 

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.
No Results Posted