Skip to content

The effect of Erythropoietin Alfa in traumatic brain injury

Comparison of the effect of Erythropoietin alfa and Placebo on Glasgow Coma Scale Score and Glasgow Outcome Score of the patients with moderate to severe traumatic brain injury

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT201204149462N1
Enrollment
70
Registered
2012-06-14
Start date
2009-05-31
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. External causes of morbidity and mortality

Interventions

Intervention 1: Intervention arms patients will receive 400 IU/Kg Erythropoietin Alfa, intravenously, in a single dose. Intervention 2: Control group will recieve 2cc of intravenous normal saline in a
Treatment - Drugs
Placebo
Intervention arms patients will receive 400 IU/Kg Erythropoietin Alfa, intravenously, in a single dose
Control group will recieve 2cc of intravenous normal saline in a single dose

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
4 Years to 70 Years

Inclusion criteria

Inclusion criteria: Inclusion and exclusion Criteria were as follows: Patients with blunt head trauma; GCS equal or less than 13 in admission time; patient admitted in hospital less than 8 hours after trauma Exclusion Criteria: Patient’s GCS above 13 in admission time; patients with GCS=3 and pupils without reaction to light in admission time; penetrating head injury; O2-Sat bellow 90% in admission time; admission after 8 hours of injury; any critical injury in any part of the body except for head; patient with history of CPR before the intervention; any kind of severe pre-existing systemic co-morbidity; history of hypersensitivity to any injected drug; any patients with drug history of anticoagulant therapy; age under 4 years or above 70 years

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
GCS score. Timepoint: Admission time, 24 hourse. 7 days. Method of measurement: Clinical assessment (Physical examination).

Secondary

MeasureTime frame
Glasgow Outcome Scale Score. Timepoint: 6th mounth. Method of measurement: Clinical assessment (Physical examination).;Decrease in hospital stay. Timepoint: Day of discharge. Method of measurement: days.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAnowshiravan Ninezhad

Tehran university of medical sciences

anushnik@yahoo.com+98 21 8822 0040

Outcome results

None listed

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