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
This clinical trial is designed to study the effect of erythropoietin alfa in patients with Moderate and severe traumatic brain injury. 70 patients with traumatic brain injury with Glasgow Coma SCale Score of less than 13 and without penetrating head trauma, who are reffered to Tehran Shariati hospital, would be classified to Severe (Glasgow Coma SCale Score of less than 9) or moderate (Glasgow Coma SCale Score more than 8 and less than 14) subgroups and then each subgroup randomly (by random block sampling) will be divided to two arms of intervention and Control. In the intervention arms patients will be received 400 IU/Kg Erythropoietin Alfa, intravenously and in Control group 2cc normal saline will be injected as placebo. In both intervention and control arms Glasgow Coma Scale Score would be measured in 24 hours and also seventh day and Glasgow Outcome Scale will be assessed in 6 month.Additionally, hospital stay, mortality and adverse events will be compared in both arms.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201204149462N1
Registration date:2012-06-14, 1391/03/25
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-06-14, 1391/03/25
Registrant information
Name
Anowshiravan Niknezhad
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 9922 0040
Email address
aniknejad88@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2009-05-31, 1388/03/10
Expected recruitment end date
2011-10-23, 1390/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
The effect of Erythropoietin Alfa in traumatic brain injury
Purpose
Treatment
Inclusion/Exclusion 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
Age
From 4 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Research department of tehran university of medical sciences
City
Tehran
Postal code
Approval date
2012-05-29, 1391/03/09
Ethics committee reference number
91.130.235
Health conditions studied
1
Description of health condition studied
Traumatic Brain Injury
ICD-10 code
V01-Y98
ICD-10 code description
External causes of morbidity and mortality
Primary outcomes
1
Description
GCS score
Timepoint
Admission time, 24 hourse. 7 days
Method of measurement
Clinical assessment (Physical examination)
Secondary outcomes
1
Description
Glasgow Outcome Scale Score
Timepoint
6th mounth
Method of measurement
Clinical assessment (Physical examination)
2
Description
Decrease in hospital stay
Timepoint
Day of discharge
Method of measurement
days
Intervention groups
1
Description
Intervention arms patients will receive 400 IU/Kg Erythropoietin Alfa, intravenously, in a single dose
Category
Treatment - Drugs
2
Description
Control group will recieve 2cc of intravenous normal saline in a single dose
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran Dr.Shariati Hospital
Full name of responsible person
Anowshiravan Niknezhad
Street address
Neurosurgery Office, Shariati hospital, Amirabad
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Anowshiravan Niknezhad
Street address
Neurosurgery office, Shariati Hospital, Amirabad
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran university of medical sciences
Full name of responsible person
Anowshiravan Ninezhad
Position
Resident of Neurosurgery
Other areas of specialty/work
Street address
Neurosurgery Office, Shariati hospital, Amirabad
City
Tehran
Postal code
Phone
+98 21 8822 0040
Fax
Email
anushnik@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Masood Mehrazin
Position
University Professor
Other areas of specialty/work
Street address
Neurosurgery office, Shariati hospital, Amirabad
City
Tehran
Postal code
Phone
+98 21 8822 0040
Fax
Email
aniknejad88@razi.tums.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Anowshiravan Niknezhad
Position
Neurosurgery Resident
Other areas of specialty/work
Street address
Neurosurgery Office, Shariati hospital, Amirabad
City
Tehran
Postal code
1411713135
Phone
+98 21 8822 0040
Fax
+98 21 8822 0040
Email
anushnik@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)