The present study investigates the effect of Erithrpoietin on Neurologic outcomes in brain ischemic patients.The method used is Randomized Double Blind Multi-central Clinical Trial.The inclusion criterion is brain ischemic Patients between 18 to 75 years of age range who possess decline of consciousness level and have been hospitalized due to brain ischemia with the GCS<9.The exclusion criterion for the present study is those outside the age range mentioned plus Non-ischemic patients.The sample size is 50 participants : including 25 participants for observation and 25 for intervention.In intervention group, 4000 units of Erithropoietin .Subcutaneous is injected in the first 24 hour and 48 hour after the occurrence of Brain Ischemia. In the observation group,1cc of Normalsalin Serum Subcutaneous is injected. The conciuosness status of the patients is examined on the 7th, 14th, 21st, and 90th days .
General information
Acronym
kermanshah anesthesia study tes
IRCT registration information
IRCT registration number:IRCT2013052713486N1
Registration date:2013-10-15, 1392/07/23
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-10-15, 1392/07/23
Registrant information
Name
Ali Darabi
Name of organization / entity
Kermanshah Medical Sceince University
Country
Iran (Islamic Republic of)
Phone
+98 83 1835 1257
Email address
darabi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kermanshah University of Medical Sciences
Expected recruitment start date
2013-07-01, 1392/04/10
Expected recruitment end date
2014-01-30, 1392/11/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the Effect of Erithropoietin on Neurologic Outcome in Brain Ischemic Patients
Public title
Investigating the Effect of Erithropoietin on Neurologic Outcome in Brain Ischemic Patients
Purpose
Treatment
Inclusion/Exclusion criteria
The inclusion criterion is brain ischemic Patients between 18 to 75 years of age range who have been hospitilized in ICU wards and have GCS,9. The exclusion criterion for the present study is those outside the age range mentioned-from 18 to 75- Non-ischemic patients , poly-sythemic patients, and those having another brain-related diseases -GCS<9, malignant cancer, disordered liver function, and pregnant women.
Age
From 18 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
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
Kermanshah Medical Science University
Street address
Shahid Beheshti blvd.,
City
Kermanshah
Postal code
6714567915
Approval date
2013-01-17, 1391/10/28
Ethics committee reference number
48673
Health conditions studied
1
Description of health condition studied
Brain Ischemic Patients
ICD-10 code
G46
ICD-10 code description
Vascular syndromes of brain in cerebrovascular diseases
Primary outcomes
1
Description
Glasgow Coma Scale
Timepoint
before the interventoin- 7 days after the intervention-14,21, and 90 days of intervention
Method of measurement
Glasgow Coma Scale
2
Description
Glasgow Outcome Scale
Timepoint
before the interventoin- 7 days after the intervention-14,21, and 90 days of intervention
Method of measurement
Glasgow Outcome Scale
3
Description
National Institutes of Health Stroke Scale
Timepoint
before the interventoin- 7 days after the intervention-14,21, and 90 days of intervention
Method of measurement
National Institutes of Health Stroke Scale
Secondary outcomes
1
Description
Duration of hospitalization
Timepoint
The last day of hospitalization
Method of measurement
Numeration of hospitalizing days
Intervention groups
1
Description
In control group, 1cc of Normalsalin 0.9 percent is injected in 48 and 72 first hours.
Category
Placebo
2
Description
4000 units of Erithropoietin Subcutaneous is injected in the 48 and 72 first hours after the start of the signs
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza Clinical Center
Full name of responsible person
Darabi Ali, Anethesia Resident
Street address
University Blvd.,
City
Kermanshah,
2
Recruitment center
Name of recruitment center
Farabi Clinical Center
Full name of responsible person
Darabi Ali, Anethesia Resident
Street address
Eisar Square
City
Kermanshah,
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah Medical Science University
Full name of responsible person
Dr. Farid Najafi, Research Deputy of University
Street address
University building no.2, Shahid Beheshti Blvd.,
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah Medical Science University
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
Kermanshah Medical Science University
Full name of responsible person
Darabi, Ali
Position
Anethesia Residebt/Performance Correspondent
Other areas of specialty/work
Street address
Building No.2, Shahid Beheshti Blvd.,
City
Kermanshah
Postal code
6714673159
Phone
+98 83 1838 4185
Fax
+98 83 1838 6835
Email
darabi1354@gmail.com
Web page address
kums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah Medical Science University
Full name of responsible person
Roshani, Bahman
Position
Assistant Professor
Other areas of specialty/work
Street address
Building N0.2, Shahid bbeheshti Blvd.,
City
Kermanshah
Postal code
6714673159
Phone
+98 83 1838 4185
Fax
+98 83 1838 6835
Email
broshani@yahoo.com
Web page address
kums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah Medical Science University
Full name of responsible person
Darabi, Ali
Position
Anethesia Resident
Other areas of specialty/work
Street address
Emam Reza Clinical Center
City
Kermanshah
Postal code
6714673159
Phone
+98 83 1427 6331
Fax
+98 83 1835 1257
Email
darabi1354@gmail.com
Web page address
kums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)