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Clinical Trials/NCT03867071
NCT03867071CompletedNot Applicable

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

Centre Hospitalier Universitaire de Nīmes2 sites in 1 country60 target enrollmentStarted: October 1, 2005Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
60
Locations
2
Primary Endpoint
number of administered red blood cells
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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?

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Other
Masking
Triple (Participant, Care Provider, Investigator)

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

Placebo (PLA) group

Placebo Comparator

Intervention: placebo injection (Other)

erythropoietin (EPO) group

Experimental

Intervention: recombinant erythropoietin injection (Other)

Outcomes

Primary Outcomes

number of administered red blood cells

Time Frame: Day 30

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Centre Hospitalier Universitaire de Nīmes
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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