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

Primary Purpose

Multiple Trauma

Status
Unknown status
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
erythropoietin
placebo
Sponsored by
Tehran University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Trauma focused on measuring multiple trauma

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sina HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

apachi 2 saps 30 days mortality

Secondary Outcome Measures

30 days mortality

Full Information

First Posted
February 13, 2008
Last Updated
November 17, 2010
Sponsor
Tehran University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT00622934
Brief Title
Relationship Between Erythropoietin Administration and Stress Responses in Trauma Patients
Acronym
EPREX
Official Title
Relationship Between Clinical Recovery and Oxidative Stress and Inflammation Following Usage of Erythropoietin in Admitted Traumatic Patient In Intensive Care Unit
Study Type
Interventional

2. Study Status

Record Verification Date
November 2010
Overall Recruitment Status
Unknown status
Study Start Date
July 2007 (undefined)
Primary Completion Date
May 2008 (Anticipated)
Study Completion Date
May 2008 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Tehran University of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Trauma
Keywords
multiple trauma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
erythropoietin
Other Intervention Name(s)
EPREX
Intervention Description
300mg/kg erythropoietin 3 times on the first week of admission
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo
Primary Outcome Measure Information:
Title
apachi 2 saps 30 days mortality
Time Frame
untill discharge
Secondary Outcome Measure Information:
Title
30 days mortality
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
mojtaba mojtahedzade
Phone
0982166701041
Email
Mojtahed@sina.tums.ac.ir
First Name & Middle Initial & Last Name or Official Title & Degree
mostafa mohammady
Phone
0982166735017
Email
mohammady_m2007@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MOJTABA MOJTAHEDZADE
Organizational Affiliation
TUMS
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
MOSTAFA MOHAMMADY
Organizational Affiliation
TUMS
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
MOJTABA MOJTAHED
Organizational Affiliation
TUMS
Official's Role
Study Director
Facility Information:
Facility Name
Sina Hospital
City
Tehran
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
MOJTAHEDZADE
Phone
098216701041-9
First Name & Middle Initial & Last Name & Degree
MOHAMMADY
Phone
0989126053454
First Name & Middle Initial & Last Name & Degree
MOSTAFA MOHAMMADY
First Name & Middle Initial & Last Name & Degree
MOJTABA MOJTAHEDZADE

12. IPD Sharing Statement

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Relationship Between Erythropoietin Administration and Stress Responses in Trauma Patients

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