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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2010 by Tehran University of Medical Sciences.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00622934
First Posted: February 25, 2008
Last Update Posted: November 18, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Tehran University of Medical Sciences
February 13, 2008
February 25, 2008
November 18, 2010
July 2007
May 2008   (Final data collection date for primary outcome measure)
apachi 2 saps 30 days mortality [ Time Frame: untill discharge ]
Same as current
Complete list of historical versions of study NCT00622934 on ClinicalTrials.gov Archive Site
30 days mortality [ Time Frame: 30 days ]
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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
  • 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.
 
Unknown status
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
Sexes Eligible for Study: All
40 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Iran, Islamic Republic of
 
 
NCT00622934
425/195 13/4/86
Yes
Not Provided
Not Provided
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