Back to resultsEarly Administration of Recombinant Erythropoietin (RHEPO) in Transfusion Savings in Trauma Patients (EPREX)
Primary Purpose
Trauma
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
recombinant erythropoietin injection
placebo injection
Sponsored by
About this trial
This is an interventional other trial for Trauma
Eligibility 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.
Sites / Locations
- Nimes university hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
erythropoietin (EPO) group
Placebo (PLA) group
Arm Description
Outcomes
Primary Outcome Measures
number of administered red blood cells
Secondary Outcome Measures
Full Information
NCT ID
NCT03867071
First Posted
March 6, 2019
Last Updated
March 6, 2019
Sponsor
Centre Hospitalier Universitaire de Nīmes
1. Study Identification
Unique Protocol Identification Number
NCT03867071
Brief Title
Early Administration of Recombinant Erythropoietin (RHEPO) in Transfusion Savings in Trauma Patients
Acronym
EPREX
Official Title
Early Administration of Recombinant Erythropoietin (RHEPO) in Transfusion Savings in Trauma Patients
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
October 2005 (Actual)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nīmes
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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?
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trauma
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
erythropoietin (EPO) group
Arm Type
Experimental
Arm Title
Placebo (PLA) group
Arm Type
Placebo Comparator
Intervention Type
Other
Intervention Name(s)
recombinant erythropoietin injection
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
placebo injection
Intervention Description
Intravenous injection 0,9% saline solution.
Primary Outcome Measure Information:
Title
number of administered red blood cells
Time Frame
Day 30
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Nimes university hospital
City
Nîmes
ZIP/Postal Code
30029
Country
France
12. IPD Sharing Statement
Learn more about this trial
Early Administration of Recombinant Erythropoietin (RHEPO) in Transfusion Savings in Trauma Patients
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