Relationship Between Erythropoietin Administration and Stress Responses in Trauma Patients

NCT ID: NCT00622934

Last Updated: 2010-11-18

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

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2008-05-31

Brief Summary

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The purpose of this study is to determine whether Erythropoietin decrease stress responses and inflammation in trauma patient.

Detailed Description

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Transfusion of blood products has many disadvantages. Erythropoietin is used to increase red blood cells production and decrease such disadvantages.In some studies anti inflammatory effects is shown for Erythropoietin.

One of the most problems in the intensive care unit is stress response. we are going to evaluate effects of erythropoietin on oxidative stress and inflammation in trauma patient in intensive care unit.

Conditions

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Multiple Trauma

Keywords

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multiple trauma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Group Type ACTIVE_COMPARATOR

erythropoietin

Intervention Type DRUG

300mg/kg erythropoietin 3 times on the first week of admission

2

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

placebo

Interventions

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erythropoietin

300mg/kg erythropoietin 3 times on the first week of admission

Intervention Type DRUG

placebo

placebo

Intervention Type DRUG

Other Intervention Names

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EPREX

Eligibility Criteria

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Inclusion Criteria

* All multiple trauma patients\>16 years with informed consent

Exclusion Criteria

* Hypertension
* Allergy
* Erythroid leukemia
* Pregnancy and breast feeding
* Pre operative patient
* Severe cardiovascular and cerebrovascular diseases
* Thromboembolic disorders
Minimum Eligible Age

40 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tehran University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Pharmaceutical Sciences Research Center Tehran University of Medical SCIENCES

Principal Investigators

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MOJTABA MOJTAHEDZADE

Role: STUDY_CHAIR

TUMS

MOSTAFA MOHAMMADY

Role: PRINCIPAL_INVESTIGATOR

TUMS

MOJTABA MOJTAHED

Role: STUDY_DIRECTOR

TUMS

Locations

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Sina Hospital

Tehran, , Iran

Site Status RECRUITING

Countries

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Iran

Central Contacts

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mojtaba mojtahedzade

Role: CONTACT

Phone: 0982166701041

Email: [email protected]

mostafa mohammady

Role: CONTACT

Phone: 0982166735017

Email: [email protected]

Facility Contacts

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MOJTAHEDZADE

Role: primary

MOHAMMADY

Role: backup

Other Identifiers

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425/195 13/4/86

Identifier Type: -

Identifier Source: org_study_id