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IRCT2013072414138N1 IRCT 2013-09-08 Kashan University of Medical Sciences, Deputy of Research Effect of erythropoietin on outcome of severe brain injured patients Comparison of the effects of erythropoietin and placebo on lesion size and outcome (Glasgow Outcome Score) in the severe brain-injured patients 2013-09-23 anticipated 60 Complete https://irct.ir/trial/13814 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment. N/A Traumatic brain injury. Intervention 1: In the intervention group: After the arrival of the patient into the study and within 8 hours after the occurrence of the brain Injury, erythropoietin will be infused at the rate of 33000 IU/50 ml normal saline /30 min intravenously. This dosage will be repeated in next 24 and 48 hours. Intervention 2: In the control group: After the arrival of the patient into the study and within 8 hours after the occurrence of the brain Injury, normal saline will be infused at the rate 50 ml in 30 minutes intravenously. This dosage will be repeated in next 24 and 48 hours.
public Mehrdad Mahdian
Kashan University of Medical Sciences
Kashan Iran (Islamic Republic of) 8719674591 +98 36 1562 0634 mahdian_m@kaums.ac.ir Kashan University of Medical Sciences scientific Mohammd Reza Fazel
Qutb-e ravandi Blvd
Kashan Iran (Islamic Republic of) 8719674591 +98 36 1562 0634 Drfazel@yahoo.com Kashan University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: severe brain injury (Glasgow coma scale less than or equal to 8) with a single brain lesion volume less than 30 ml or those who have diffuse axonal injury; age between 15-65 years; no need for surgical operation; possibility of following up during the study period; having informed consent from first-degree relatives. Exclusion criteria: mild to moderate brain injury; patients with massive brain lesions( more than 30 ml volume); age less than 15 and over 65; surgical operation; cases with neoplasia in skull; multiple trauma; myeloproliferative diseases; polycythemia; sensitivity to erythropoietin; hyperkalemia; creatinine more than 3 mg/dl; all patients that their following- up is not guaranteed during the study; participating other trials; history of deep vein thrombosis; pregnancy; clinical brain death (without brain stem reflexes). 15 years 65 years Both S06.2 , S0 Diffuse brain injury , Focal brain injury Treatment - Drugs Treatment - Drugs In the intervention group: After the arrival of the patient into the study and within 8 hours after the occurrence of the brain Injury, erythropoietin will be infused at the rate of 33000 IU/50 ml normal saline /30 min intravenously. This dosage will be repeated in next 24 and 48 hours. In the control group: After the arrival of the patient into the study and within 8 hours after the occurrence of the brain Injury, normal saline will be infused at the rate 50 ml in 30 minutes intravenously. This dosage will be repeated in next 24 and 48 hours. Patient's outcome. Timepoint: 3 and 6 month after intervention. Method of measurement: Based on Glasgow coma scale. Lesion size. Timepoint: Before, 15 and 30 days after intervention. Method of measurement: Based on CT-Scan and radiologist's report. Kashan University of Medical Sciences, Deputy of Research Approved 2013-05-18 Kashan University of Medical Sciences Ghotb-e ravandi Blvd. Kashan Iran (Islamic Republic of)