Relationship Between Erythropoietin Administration and Stress Responses in Trauma Patients

Multiple Trauma Clinical Trial

— EPREX  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00622934
• Other study ID #: 425/195 13/4/86
• Status: Recruiting
• Phase: Phase 2
• First received: February 13, 2008
• Last updated: November 17, 2010
• Start date: July 2007
• Est. completion date: May 2008

Study information

• Verified date: November 2010
• Source: Tehran University of Medical Sciences
• Contact: mojtaba mojtahedzade
• Phone: 0982166701041
• Email: Mojtahed[@]sina.tums.ac.ir
• Is FDA regulated: No
• Health authority: Iran: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Trauma

Intervention

Drug:
• erythropoietin
300mg/kg erythropoietin 3 times on the first week of admission
• placebo
placebo

Locations

Country	Name	City	State
Iran, Islamic Republic of	Sina Hospital	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Tehran University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	apachi 2 saps 30 days mortality		untill discharge	No
Secondary	30 days mortality		30 days	No