Relationship Between Erythropoietin Administration and Stress Responses in Trauma Patients - Full Text View

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

This study is currently recruiting participants.

Verified by Tehran University of Medical Sciences, February 2008

First Received: February 13, 2008 Last Updated: February 21, 2008 History of Changes

Sponsored by:	Tehran University of Medical Sciences
Information provided by:	Tehran University of Medical Sciences
ClinicalTrials.gov Identifier:	NCT00622934

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 II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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:

MedlinePlus related topics: Injuries Wounds

Drug Information available for: Erythropoietin Epoetin alfa

U.S. FDA Resources

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
1: Active Comparator	Drug: erythropoietin 300mg/kg erythropoietin 3 times on the first week of admission
2: Placebo Comparator	Drug: placebo 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

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 ( Pharmaceutical Sciences Research Center Tehran University of Medical SCIENCES )
Study ID Numbers:	425/195 13/4/86
Study First Received:	February 13, 2008
Last Updated:	February 21, 2008
ClinicalTrials.gov Identifier:	NCT00622934 History of Changes
Health Authority:	Iran: Ethics Committee

Keywords provided by Tehran University of Medical Sciences:

multiple trauma

Study placed in the following topic categories:

Epoetin Alfa
Multiple Trauma
Hematinics
Wounds and Injuries

Disorders of Environmental Origin
Stress
Inflammation

Additional relevant MeSH terms:

Epoetin Alfa
Multiple Trauma
Hematinics
Therapeutic Uses

Hematologic Agents
Wounds and Injuries
Disorders of Environmental Origin
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 03, 2009