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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by Tehran University of Medical Sciences.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Tehran University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT00622934
First received: February 13, 2008
Last updated: November 17, 2010
Last verified: November 2010
History of Changes

February 13, 2008
November 17, 2010
July 2007
May 2008   (final data collection date for primary outcome measure)
apachi 2 saps 30 days mortality [ Time Frame: untill discharge ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00622934 on ClinicalTrials.gov Archive Site
30 days mortality [ Time Frame: 30 days ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Relationship Between Erythropoietin Administration and Stress Responses in Trauma Patients
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.

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.
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Multiple Trauma
  • Drug: erythropoietin
    300mg/kg erythropoietin 3 times on the first week of admission
    Other Name: EPREX
  • Drug: placebo
    placebo
    Other Name: placebo
  • Active Comparator: 1
    Intervention: Drug: erythropoietin
  • Placebo Comparator: 2
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
May 2008
May 2008   (final data collection date for primary outcome measure)

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
Both
40 Years to 65 Years
No
Contact: mojtaba mojtahedzade 0982166701041 Mojtahed@sina.tums.ac.ir
Contact: mostafa mohammady 0982166735017 mohammady_m2007@yahoo.com
Iran, Islamic Republic of
 
NCT00622934
425/195 13/4/86
Yes
Pharmaceutical Sciences Research Center Tehran University of Medical SCIENCES
Tehran University of Medical Sciences
Not Provided
Study Chair: MOJTABA MOJTAHEDZADE TUMS
Principal Investigator: MOSTAFA MOHAMMADY TUMS
Study Director: MOJTABA MOJTAHED TUMS
Tehran University of Medical Sciences
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP