NCT03867071

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2005

Completed
6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
6.7 years until next milestone

First Submitted

Initial submission to the registry

March 6, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 7, 2019

Completed
Last Updated

March 7, 2019

Status Verified

March 1, 2019

Enrollment Period

6.8 years

First QC Date

March 6, 2019

Last Update Submit

March 6, 2019

Conditions

Trauma

Outcome Measures

Primary Outcomes (1)

  • number of administered red blood cells

    Day 30

Study Arms (2)

erythropoietin (EPO) group

EXPERIMENTAL
Other: recombinant erythropoietin injection

Placebo (PLA) group

PLACEBO COMPARATOR
Other: placebo injection

Interventions

recombinant erythropoietin injectionOTHER

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).

erythropoietin (EPO) group
placebo injectionOTHER

Intravenous injection 0,9% saline solution.

Placebo (PLA) group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nimes university hospital

Nîmes, 30029, France

Location

MeSH Terms

Conditions

Wounds and Injuries

Interventions

Erythropoietin

Intervention Hierarchy (Ancestors)

Colony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 6, 2019

First Posted

March 7, 2019

Study Start

October 1, 2005

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

March 7, 2019

Record last verified: 2019-03

Locations

FR(1)