1) Objective: To evaluate the efficacy of Cyclosporine-A(CsA) in improvement of consciousness and cognitive dysfunction of patients with diffuse axonal injury(DAI) after Traumatic Brain Injury(TBI).
2) Design: This study is designed as a randomized double-blind placebo-controlled with 100 patients suffered from DAI after TBI.
3) Setting and conduct:100 patients that suffered from DAI after Traumatic Brain Injury are underwent the study if consent form is completed by first relatives and all of them had inclusion criteria of the study.
4) Participants including major eligibility criteria
Inclusion criteria are:
Age between 16 and 75 years; Glasgow coma scale(GCS) score less than 10 in 24 hours of admission; Complete consent form; βHCG is negative and no pregnant patients.
Exclusion criteria are:
Negative brain stem reflex response; Patients with immune deficiency; Liver and kidney diseases; Penetrative brain injury; Multiple trauma; Past medical history of cancer; And patients that need emergency surgery; Pregnant women
5) Intervention: 100 patients that included to this study are divided to 2 groups, Cyclosporine group and Placebo group, by randomized double blinded fashion. In first 8 hours of admission, Cyclosporine A was administered to the Cyclosporine group (n=50) as 5 mg/kg/24h via 250 ml dextrose water 5% solution(DW5%) during the first eight hours after trauma. The control group (n=50) received only DW5% in the same course.
6) Main outcome measures(variables): GCS, GOS-E and MMSE tests that are evaluated in both groups on discharge time, 3 and 6 months after trauma.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013011712164N1
Registration date:2013-02-16, 1391/11/28
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-02-16, 1391/11/28
Registrant information
Name
Salman Abbasifard
Name of organization / entity
Neurosurgery Department, Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1669 0226
Email address
abbasi_fard@resident.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research Isfahan University of Medical Sciences
Expected recruitment start date
2012-03-19, 1390/12/29
Expected recruitment end date
2013-03-20, 1391/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of cyclosporine-A on neuro-recovery of diffuse axonal injury in comparison with placebo.
Public title
The Effect of Cyclosporine on Head Trauma
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria are:
Age between 16 and 75 years; GCS score less than 10 in 24 hours of admission; Complete consent form; βHCG is negative and no pregnant patients.
Exclusion criteria are:
Negative brain stem reflex response; Patients with immune deficiency; Liver and kidney diseases; Penetrative brain injury; Multiple trauma; Past medical history of cancer; And patients that need emergency surgery; Pregnant women
Age
From 16 years old to 75 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
100
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
The Ethics Committee of Isfahan University of Medical Sciences
Street address
The Ethics Committee Department, Library builiding, Isfahan University of Medical Scieces, Hezar Jareeb Ave
Cyclosporine-A, vial solution, 5mg/kg in 250 mili liter dextrose water 5% solution(DW5%) during the first 24hour of admission, one dose is administrated in all periods of the study.
Category
Treatment - Drugs
2
Description
Intravenous, slow infusion of 250 mili liter of dextrose water 5% solution(DW5%) during the first 24hour of admission, that this solution is administrated one time in all periods of the study.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-Zahra Hospital
Full name of responsible person
Dr.Mehdi Mahmoudkhani
Street address
Soffeh bolvar
City
Isfahan
2
Recruitment center
Name of recruitment center
Ayatolah Kashani Hospital
Full name of responsible person
Dr.Mohammad Motahari
Street address
Kashani St
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Isfahan University of Medical Science
Full name of responsible person
Akram Mazaheri
Street address
No.4 building, Isfahan University of Medical Sciences, Hezar Jareeb St
City
Isfahan
Grant name
Grant code / Reference number
390356
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Isfahan University of Medical Science
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
Neurosurgery Department, Isfahan University of Medical Sciences
Full name of responsible person
Dr.Salman Abbasifard
Position
Neurosurgery Resident
Other areas of specialty/work
Street address
Neurosurgery Department, Al Zahra Hospital, Soffeh St
City
Isfahan
Postal code
8174675731
Phone
+98 31 1668 5555
Fax
Email
abbasi_fard@resident.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Neurosurgery Department, Isfahan University of Medical Sciences
Full name of responsible person
Dr.Bahram Aminmansour
Position
Neurosurgery Associated Professor
Other areas of specialty/work
Street address
Neurosurgery Department, Al-Zahra Hospital, Soffeh St
City
Isfahan
Postal code
8174675731
Phone
+98 31 1668 5555
Fax
Email
aminmansour@med.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Neurosurgery Department, Isfahan University of Medical Sciences
Full name of responsible person
Salman Abbasifard
Position
Neurosurgery Resident
Other areas of specialty/work
Street address
Neurosurgery Department, Al Zahra Hospita, Soffeh St
City
Isfahan
Postal code
8174675731
Phone
+98 31 1668 5555
Fax
Email
Abbasi_fard@resident.mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)