Skip to content

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT2013072414138N1
Enrollment
60
Registered
2013-09-08
Start date
2013-09-23
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Traumatic brain injury. Diffuse brain injury , Focal brain injury

Interventions

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 33
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 nor
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 intrave

Sponsors

Kashan University of Medical Sciences, Deputy of Research
Lead Sponsor

Eligibility

Sex/Gender
All
Age
15 Years to 65 Years

Inclusion criteria

Inclusion criteria: 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).

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMehrdad Mahdian

Kashan University of Medical Sciences

mahdian_m@kaums.ac.ir+98 36 1562 0634

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026