This study is carried out as a randomized clinical trial (Prospective randomized clinical trial).
People who are eligible for inclusion, in the first 8 hours after traumatic brain injury, are classified accidentally In to intervention group and the control group.
For patients in the intervention group administrated 1 mg / kg every 12 hours for up to 3 days of progesterone as IM injection and not be prescribed any drug for patient in the control group
GOS and MFIM levels in patients, one and three months after it, is reviewed and compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012080810536N1
Registration date:2012-12-01, 1391/09/11
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-12-01, 1391/09/11
Registrant information
Name
Majid Kalbasi
Name of organization / entity
Islamic azad university najaf abad
Country
Iran (Islamic Republic of)
Phone
+98 31 2521 6952
Email address
dr-kalbasi@smd.iaun.ac.ir
Recruitment status
Recruitment complete
Funding source
Islamic Azad University Najaf Abad
Expected recruitment start date
2012-10-22, 1391/08/01
Expected recruitment end date
2012-12-21, 1391/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of improved outcomes from the administration of progesterone after severe traumatic brain injury
Public title
Effect of progestrone on head injury
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: all male and female patients 18 years and more with admission GCS 8-4 during the first 8 hours on a voluntary and informed consent
Exclusion criteria: injuries incompatible with life; bilateral dilated and no response to light pupils; spinal cord injury with neurological deficit; cardiopulmonary arrest; status epilepticus on arrival; initial systolic blood pressure less than 90; initial oxygen saturation less than 90%; pregnant women; any known previous or current cancer; known sensitivity to progesterone; known Coagulation disorders and lack of desire to continue research.
Age
From 18 years old to 100 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
48
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
clinicaltrial.gov
Secondary trial Id
NCT01143064
Registration date
2010-06-10, 1389/03/20
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahan University of Medical Sciences
Street address
Isfahan, Azadi sq , Isfahan University of Medical Sciences
City
Isfahan
Postal code
Approval date
2012-10-22, 1391/08/01
Ethics committee reference number
491007
Health conditions studied
1
Description of health condition studied
Head injury
ICD-10 code
S06
ICD-10 code description
Intracranial injury
Primary outcomes
1
Description
Glasgow Outcome Score
Timepoint
One and three mounths after intervention
Method of measurement
GOS
2
Description
Functional Independence Measure
Timepoint
One and three mounts after intervention
Method of measurement
FIM
Secondary outcomes
empty
Intervention groups
1
Description
For patients in the intervention group administrated 1 mg / kg every 12 hours for up to 3 days of progesterone as IM injection.
Category
Treatment - Drugs
2
Description
For patients in control group, progestrone not will be administratedAssesment of patients carry out according to GOS and FIM, one and three months after third day after admidet in hospital.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali Sharaiti hospital
Full name of responsible person
Majid Kalbasi
Street address
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University Najaf Abad
Full name of responsible person
Kamran Tavakol
Street address
Islamic azad university najaf ababd-medicine faculty
City
Najaf abad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University Najaf Abad
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
Islamic Azad University Najaf Abad
Full name of responsible person
Majid Kalbasi
Position
Student of Medicine, Internship
Other areas of specialty/work
Street address
Chaharbagh bala ave- shariati hospital
City
Isfahan
Postal code
Phone
+98 31 1626 5002
Fax
Email
kalbasimajid@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University Najaf Abad
Full name of responsible person
Farid Zolfaghari
Position
Assistant Professor of Neurosurgery
Other areas of specialty/work
Street address
Chahar bagh bala ave-shariati hospital
City
Isfahan
Postal code
Phone
+98 31 1626 5033
Fax
Email
faridzol47@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University of Najaf Abad
Full name of responsible person
Majid Kalbasi
Position
Student of Medicine, Internship
Other areas of specialty/work
Street address
City
Isfahan
Postal code
Phone
+98 31 1626 5002
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)