Relationship Between Erythropoietin Administration and Stress Responses in Trauma Patients (EPREX)

November 17, 2010 updated by: Tehran University of Medical Sciences

Relationship Between Clinical Recovery and Oxidative Stress and Inflammation Following Usage of Erythropoietin in Admitted Traumatic Patient In Intensive Care Unit

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Iran, Islamic Republic of
      • Tehran, Iran, Islamic Republic of
        • Recruiting
        • Sina Hospital
        • Contact:
          • MOJTAHEDZADE
          • Phone Number: 098216701041-9
        • Contact:
          • MOHAMMADY
          • Phone Number: 0989126053454
        • Sub-Investigator:
          • MOSTAFA MOHAMMADY
        • Principal Investigator:
          • MOJTABA MOJTAHEDZADE

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 2
Drug: placebo
placebo
Active Comparator: 1
Drug: erythropoietin
300mg/kg erythropoietin 3 times on the first week of admission
Other Names:
  • EPREX

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
apachi 2 saps 30 days mortality
Time Frame: untill discharge
untill discharge

Secondary Outcome Measures

Outcome Measure
Time Frame
30 days mortality
Time Frame: 30 days
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tehran University of Medical Sciences

Investigators

  • Study Chair: MOJTABA MOJTAHEDZADE, TUMS
  • Principal Investigator: MOSTAFA MOHAMMADY, TUMS
  • Study Director: MOJTABA MOJTAHED, TUMS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (Anticipated)

May 1, 2008

Study Completion (Anticipated)

May 1, 2008

Study Registration Dates

First Submitted

February 13, 2008

First Submitted That Met QC Criteria

February 21, 2008

First Posted (Estimate)

February 25, 2008

Study Record Updates

Last Update Posted (Estimate)

November 18, 2010

Last Update Submitted That Met QC Criteria

November 17, 2010

Last Verified

November 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 425/195 13/4/86

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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