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

Tehran University of Medical Sciences

Status and phase: Unknown; Phase 2

Conditions: Multiple Trauma

Treatments: Drug: placebo; Drug: erythropoietin

Study type: Interventional

Funder types: Other

Identifiers

NCT00622934

425/195 13/4/86

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 40 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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20 participants in 2 patient groups, including a placebo group

1

Active Comparator group

Treatment:

Drug: erythropoietin

2

Placebo Comparator group

Treatment:

Drug: placebo