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

NCT ID: NCT03867071

Last Updated: 2019-03-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Study Completion Date

2012-07-31

Brief Summary

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

Detailed Description

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

Conditions

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Trauma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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erythropoietin (EPO) group

Group Type EXPERIMENTAL

recombinant erythropoietin injection

Intervention Type 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 (PLA) group

Group Type PLACEBO_COMPARATOR

placebo injection

Intervention Type OTHER

Intravenous injection 0,9% saline solution.

Interventions

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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).

Intervention Type OTHER

placebo injection

Intravenous injection 0,9% saline solution.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Nimes university hospital

Nîmes, , France

Site Status

Countries

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France

Other Identifiers

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PHRCI/2004/AC-01

Identifier Type: -

Identifier Source: org_study_id

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