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

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ClinicalTrials.gov Identifier: NCT00622934
Recruitment Status : Unknown
Verified November 2010 by Tehran University of Medical Sciences.
Recruitment status was:  Recruiting
First Posted : February 25, 2008
Last Update Posted : November 18, 2010
Sponsor:
Information provided by:
Tehran University of Medical Sciences

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

Condition or disease Intervention/treatment Phase
Multiple Trauma Drug: erythropoietin Drug: placebo Phase 2

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  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Relationship Between Clinical Recovery and Oxidative Stress and Inflammation Following Usage of Erythropoietin in Admitted Traumatic Patient In Intensive Care Unit
Study Start Date : July 2007
Estimated Primary Completion Date : May 2008
Estimated Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1 Drug: erythropoietin
300mg/kg erythropoietin 3 times on the first week of admission
Other Name: EPREX
Placebo Comparator: 2 Drug: placebo
placebo



Primary Outcome Measures :
  1. apachi 2 saps 30 days mortality [ Time Frame: untill discharge ]

Secondary Outcome Measures :
  1. 30 days mortality [ Time Frame: 30 days ]


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Ages Eligible for Study:   40 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00622934


Contacts
Contact: mojtaba mojtahedzade 0982166701041 Mojtahed@sina.tums.ac.ir
Contact: mostafa mohammady 0982166735017 mohammady_m2007@yahoo.com

Locations
Iran, Islamic Republic of
Sina Hospital Recruiting
Tehran, Iran, Islamic Republic of
Contact: MOJTAHEDZADE    098216701041-9      
Contact: MOHAMMADY    0989126053454      
Sub-Investigator: MOSTAFA MOHAMMADY         
Principal Investigator: MOJTABA MOJTAHEDZADE         
Sponsors and Collaborators
Tehran University of Medical Sciences
Investigators
Study Chair: MOJTABA MOJTAHEDZADE TUMS
Principal Investigator: MOSTAFA MOHAMMADY TUMS
Study Director: MOJTABA MOJTAHED TUMS

Responsible Party: Pharmaceutical Sciences Research Center Tehran University of Medical SCIENCES
ClinicalTrials.gov Identifier: NCT00622934     History of Changes
Other Study ID Numbers: 425/195 13/4/86
First Posted: February 25, 2008    Key Record Dates
Last Update Posted: November 18, 2010
Last Verified: November 2010

Keywords provided by Tehran University of Medical Sciences:
multiple trauma

Additional relevant MeSH terms:
Wounds and Injuries
Multiple Trauma
Epoetin Alfa
Hematinics