The purpose of this study is evaluation of neuroprotective effects of memantine in adult patients with traumatic brain injury. In this randomized clinical trial,40 patients will be recruited from department of neurosurgery and intensive care unit , Imam Hussein hospital, Tehran, Iran. After randomization of the subject,20 subjects in group A will receive memantine 30mg twice daily for 7days and 20 subjects in group B will be followed as control group. Outcome measures include: Change in neuron specific enolase (NSE) from baseline to days 3 and 5 (time frame: baseline, 3 days and 5 days after intervention) Secondary outcome measures: 1- Change in Glasgow Coma scale (GCS) from baseline to day 5 (time frame: baseline and 5 days after intervention) 2-Comparison of mortality rate 3 months after intervention in two groups 3-Evaluation of relationship between neuron specific enolase level and mortality rate 4- Evaluation of relationship between neuron specific enolase level and GCS
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013022610178N4
Registration date:2013-05-07, 1392/02/17
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-05-07, 1392/02/17
Registrant information
Name
Mohammad Sistanizad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8820 0087
Email address
sistanizadm@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2013-05-05, 1392/02/15
Expected recruitment end date
2014-03-06, 1392/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Neuroprotective effects of memanthine in patients with traumatic brain injury
Public title
Effects of memanthine in traumatic brain injury
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: all patients with traumatic brain injury exclusion criteria: hemorrhagic stroke; sensitivity to memantine; acute or chronic renal failure; acute or chronic hepatic disease; acute MI (<48 hours); autoimmune diseases; administration of memantine during 6 months before stroke
Age
From 18 years old to 149 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahid Beheshti University of Medical Sciences
Street address
Velenjak Street, Shahid Chamran High Way
City
Tehran
Postal code
Approval date
2012-04-03, 1391/01/15
Ethics committee reference number
90-1-94-8104
Health conditions studied
1
Description of health condition studied
traumatic brain injury
ICD-10 code
S06
ICD-10 code description
intracranial injury
Primary outcomes
1
Description
neuron specific enolase
Timepoint
Day 1,3,5
Method of measurement
Elisa kits
Secondary outcomes
1
Description
Glasgow Coma scale
Timepoint
fraom day 1 for 7days
Method of measurement
Examination
2
Description
mortality
Timepoint
90 days after trauma
Method of measurement
Will be checked by phone
Intervention groups
1
Description
Memantine 20 mg three times per day for 7 days
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Neurosurgery, Imam Hussein medical center
Full name of responsible person
Mohammad Sistanizad
Street address
Shahid Madani Street
City
Tehran
2
Recruitment center
Name of recruitment center
Intensive care unit, Imam Hussein medical center
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Tahereh Shams
Street address
Velenjak Street, Shahid Chamran High Way
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Faculty of Pharmacy, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohammad Sistanizad
Position
Assistant Professor / Clinical Pharmacy Specialist
Other areas of specialty/work
Street address
Department of Clinical Pharmacy, Faculty of Pharmacy, Niayesh Highway
City
Tehran
Postal code
Phone
+98 21 8820 0087
Fax
Email
sistanizadm@sbmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty of Pharmacy, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohammad Sistanizad
Position
Assistant Professor / Clinical Pharmacy Specialist
Other areas of specialty/work
Street address
Department of Clinical Pharmacy, Faculty of Pharmacy, Niayesh Highway
City
Tehran
Postal code
Phone
+98 21 8820 0087
Fax
Email
sistanizadm@sbmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Faculty of Pharmacy, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Sina Akhavan salamat
Position
Other areas of specialty/work
Street address
Department of Clinical Pharmacy, Faculty of Pharmacy, Niayesh Highway
City
Tehran
Postal code
Phone
+98 21 8820 0087
Fax
Email
sina.akhavan@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)