96 patients who have inclusion criteria;The patients who suffered from severe traumatic brain injury that reffered to emergency departemant; They have Glasscow coma scale 4 to 8; They were not undergo surgery for any reason; They were not suffered from cardiopulmonary arrest will be selected then primary demographic information of patients include age, sex and time of trauma was questioned and recorded. Patient will be subgrouped in placebo and treatment group incidentally. In treatment group progestron will be administrated intravenously with 1 milligram per kilogram per 12 hours for 5 days. The information about level of conscious at arrival, sixth day,third week, third mounth was evaluated. Then the time of admision in intensive care unit, Glasscow coma scale and Glasscow outcome scale in control and treatment group will be compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014123020487N1
Registration date:2015-06-10, 1394/03/20
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-06-10, 1394/03/20
Registrant information
Name
Mohamad Ardeshiri
Name of organization / entity
Ahvaz Jundi Shapour University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 61 3374 3032
Email address
ardeshiri.m@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2014-11-22, 1393/09/01
Expected recruitment end date
2015-06-21, 1394/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of neuroprotective effect of progestron in moderate to severe traumatic brain injury
Public title
Progestron in treatment traumatic brain injury
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: The patients who suffered from sever traumatic brain injury that reffered to emergency departemant; They have Glasscow coma scale 4 to 8; They were not undergo surgery for any reason; They were not suffered from cardiopulmonary arrest
Exclusion criteria: The patient who that undergo surgery for any reason; females who are pregnant
Age
From 18 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
96
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 Ahvaz University of Medical Sciences
Street address
Ahvaz Jundi Shapour University of Medical Science, Golestan area, Ahvaz, Khuzestan, Iran
City
Ahvaz
Postal code
15794 - 61357
Approval date
2015-03-07, 1393/12/16
Ethics committee reference number
ajums.REC.1393.416
Health conditions studied
1
Description of health condition studied
Diffuse Brain Injury
ICD-10 code
S06.2
ICD-10 code description
Diffuse Brain Injury
Primary outcomes
1
Description
Average Glosscow coma scale
Timepoint
preaddmition, 6 th day, 3 month after addmition
Method of measurement
Glosscow coma scale
Secondary outcomes
1
Description
Average Glosscow outcome scale
Timepoint
At discharge time, 3 month later
Method of measurement
Glasscow outcome scale
2
Description
Duration of admission in intensive care unit before and after treatment in control and treatment group
Timepoint
In admission period
Method of measurement
Number of admission days
Intervention groups
1
Description
Intervention group:
patients in treatment group was given intravenous progestron 1 milligram per kilogam per 12 hours for 5 days.
Category
Treatment - Drugs
2
Description
Control group:Then patients in Control group will give intravenous injectionable serum every 12 hour for 5 day
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Golestan hospital of Ahvaz
Full name of responsible person
Dr mohamad ardeshiri
Street address
Golestan hospital,University of Medical Science, Golestan area, Ahvaz, Khuzestan, Iran
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz Jundi Shapour University of Medical Science
Full name of responsible person
Dr . nader saki
Street address
Vice of reasearch and technology, Ahvaz Jundi Shapour University of Medical Science, Golestan area, Ahvaz, Khuzestan, Iran
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz Jundi Shapour 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
Ahvaz Jundi Shapour University of Medical Science
Full name of responsible person
Dr mohamad ardeshiri
Position
Resident of neurosurgery-MD
Other areas of specialty/work
Street address
Ahvaz Jundi Shapour University of Medical Science, Golestan area, Ahvaz, Khuzestan, Iran
City
Ahvaz
Postal code
Phone
+98 61 3374 3032
Fax
+98 61 3374 3032
Email
ardeshiri.m@ajums.,ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz Jundi Shapour University of Medical Science
Full name of responsible person
Dr mohamad ardeshiri
Position
Resident of neurosurgey-MD
Other areas of specialty/work
Street address
Ahvaz Jundi Shapour University of Medical Science, Golestan area, Ahvaz, Khuzestan, Iran
City
Ahvaz
Postal code
Phone
+98 61 3374 3032
Fax
+98 61 3374 3032
Email
ardeshiri.m@ajums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz Jundi Shapour University of Medical Science
Full name of responsible person
Dr mohamad ardeshiri
Position
Resident of neurosurgery-MD
Other areas of specialty/work
Street address
Ahvaz Jundi Shapour University of Medical Science, Golestan area, Ahvaz, Khuzestan, Iran
City
Ahvaz
Postal code
Phone
+98 61 3374 3032
Fax
+98 61 3374 3032
Email
ardeshiri.m@ajums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)