The aim of this study is evaluation of effect of cerebrolysin on prognosis of patients with head trauma and DAI patients older than 18 yrs admitted to hospital in 48 hours after trauma .52 patients are divided to 2 subgroups randomly.Patients in control group recieve 10cc of cerebrolysin intravenously for 10 days and GCS of patients on admission,24 and 48 hours later,one week later and at the time of discharge and GOS are compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014040312888N2
Registration date:2014-05-20, 1393/02/30
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-05-20, 1393/02/30
Registrant information
Name
Mohammad Asghari
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1334 0830
Email address
asgharim@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2014-05-09, 1393/02/19
Expected recruitment end date
2014-08-21, 1393/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of cerebrolysin on patients with head trauma and diffuse axonal injury
Public title
The effect of cerebrolysin on patients with head trauma and brain injury
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients with age between 18 to 80 and traumatic brain injury and DAI,admitted to hospital before 48 hours from trauma.
Exclusion criteria:
Severe renal,liver,respiratory or heart disease,loss of conciousness because of drug or alcohol,history of CVA,pregnancy,patients with multi trauma which are life threatening,evidences of malfunction of brainstem,evidences of status epilepticus or epilepsy
Age
From 18 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
52
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
Research Deputy of Faculty Medicine
Street address
3rd floor of 2nd central bulding of Tabriz university of Medical Sciences, Daneshghah Ave. Tabriz
City
Tabriz
Postal code
3357310112
Approval date
2014-02-21, 1392/12/02
Ethics committee reference number
92211
2
Ethics committee
Name of ethics committee
Research Deputy of Faculty Medicine
Street address
3rd floor of 2nd central bulding of Tabriz university of Medical Sciences, Daneshghah Ave. Tabriz
City
Tabriz
Postal code
3357310112
Approval date
2014-02-21, 1392/12/02
Ethics committee reference number
92211
Health conditions studied
1
Description of health condition studied
Diffuse brain injury
ICD-10 code
s06.2
ICD-10 code description
Primary outcomes
1
Description
prognosis of patients
Timepoint
discharge time
Method of measurement
Questionnaire
2
Description
prognosis of patients
Timepoint
discharge time
Method of measurement
Questionnaire
Secondary outcomes
1
Description
GCS,GOS
Timepoint
Admission,24 and 48 hours later,discharge
Method of measurement
Questionnaire
2
Description
GCS,GOS
Timepoint
Admission,24 and 48 hours later,discharge
Method of measurement
Questionnaire
Intervention groups
1
Description
Placebo,Sterile water,10 cc,IV,10 days
Category
Treatment - Drugs
2
Description
Cerebrolysin,10 cc,IV,10 days
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza Educational and Training Hospital
Full name of responsible person
Nayyer Ebrahimi
Street address
Emam Reza Hospital, Golgasht St Tabriz East Azarbijan
City
tabriz
2
Recruitment center
Name of recruitment center
Emam Reza Educational and Training Hospital
Full name of responsible person
Nayyer Ebrahimi
Street address
Emam Reza Hospital, Golgasht St Tabriz East Azarbijan
City
tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Asgari Mohammad
Street address
Tabriz University of Medical Sciences,Golgasht
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
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
2
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Asgari Mohammad
Street address
Tabriz University of Medical Sciences,Golgasht
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
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
Tabriz University of Medical Sciences
Full name of responsible person
Nayyer Ebrahimi
Position
Resident of Neurosurgery
Other areas of specialty/work
Street address
Emam Reza Hospital
City
Tabriz
Postal code
Phone
+98 41 1334 0830
Fax
Email
nayyer.ebrahimi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mohammad Asghari
Position
Associate professor of neurosurgery
Other areas of specialty/work
Street address
Emam Reza Hospital
City
Tabriz
Postal code
5165678000
Phone
+98 41 1334 0830
Fax
+98 41 1334 0830
Email
asgharim@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Nayyer Ebrahimi
Position
Resident of neurosurgery
Other areas of specialty/work
Street address
Emam Reza Hospital
City
Tabriz
Postal code
Phone
+98 41 1334 0830
Fax
Email
nayyer.ebrahimi@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)