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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
  Purpose

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


Condition Intervention Phase
Multiple Trauma
Drug: erythropoietin
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Tehran University of Medical Sciences:

Primary Outcome Measures:
  • apachi 2 saps 30 days mortality [ Time Frame: untill discharge ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 30 days mortality [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: July 2007
Estimated Study Completion Date: May 2008
Estimated Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: placebo

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.

  Eligibility

Ages Eligible for Study:   40 Years to 65 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: February 13, 2008
Last Updated: November 17, 2010
Health Authority: Iran: Ethics Committee

Keywords provided by Tehran University of Medical Sciences:
multiple trauma

Additional relevant MeSH terms:
Multiple Trauma
Wounds and Injuries
Epoetin alfa
Hematinics
Hematologic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014