This study will examine the effects of estrogen in the prognosis of men 15 to 70 years old with diffuse axonal injury due to severe brain trauma. This is a randomized; single-blind; without placebo-controlled; single center study. Two parallel groups consist of 20 as case and 20 as control group randomly (crossed intricately) with diffuse axonal injury due to severe brain trauma with equal and less than 8 GCS whom admitted less than 8 hours after trauma in Tabriz emam reza hospital were taken. Patients with refractory seizure; history of deep vein thrombosis; any history of head trauma; cerebrovascular procedures; ischemic and hemorrhagic lesions in the brain; people prone to pulmonary thromboembolism and deep vein thrombosis were excluded. Patients in case group have been under medical treatment after the time of admission with conjugated estrogen (8 micrograms per kilogram for 3 days). Patients in the control group wouldn't receive another drug. Two groups will be compared of GCS at admission and discharge; GCS of discharge and 3 months later using a questionnaire.
General information
Acronym
-
IRCT registration information
IRCT registration number:IRCT2014091919227N1
Registration date:2016-01-17, 1394/10/27
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-01-17, 1394/10/27
Registrant information
Name
keyvan Aalizadeh
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1331 6956
Email address
mreza@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tabriz University of Medical Sciences
Expected recruitment start date
2014-08-23, 1393/06/01
Expected recruitment end date
2015-11-22, 1394/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of estrogen on recovery of prognosis in patient with diffuse axonal injury due to severe traumatic brain injury in men 15 to 70 years old
Public title
Effects of estrogen on prognosis of patient with diffuse axonal injury due to severe traumatic brain injury
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Men 15 to 70 years; Diffuse axonal injury diagnosis; GCS less than or equal to 8; Hospitalization in less than 8 hours of after trauma; Having informed consent to participate in the study; Lack of talent to thromboembolism.
Exclusion criteria:
Sex woman; Patients with refractory seizure; History of deep vein thrombosis or infection; Any history of head trauma; Any history of brain procedure; History of ischemic lesions and hemorrhagic stroke; People prone to pulmonary thromboembolism and deep vein thrombosis; (a) smoking; (b) a family history of deep vein thrombosis and pulmonary thromboembolism; (c) heart failure; (d) inflammatory bowel disease (ulcerative colitis); (e) a history of cancer; (f) hereditary disorders are prone to blood clots
Age
From 14 years old to 69 years old
Gender
Male
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Classification of patients will be crossed intricately.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Neurosurgery department office, Imam Reza Hospital, Daneshgah Avenue, Tabriz, East Azarbayejan, Iran
City
Tabriz
Postal code
5166614756
Approval date
2014-04-28, 1393/02/08
Ethics committee reference number
9357
Health conditions studied
1
Description of health condition studied
Diffuse axonal injury
ICD-10 code
S06.2
ICD-10 code description
Diffuse brain injury
Primary outcomes
1
Description
level of consciousness
Timepoint
Admission time, discharge time and three months after discharge
Method of measurement
Glasgow coma scale
Secondary outcomes
empty
Intervention groups
1
Description
8 micrograms of oral conjugated estrogen tablets per kg body weight, once a day until 3 days for the intervention group
Category
Treatment - Drugs
2
Description
Not prescribed any medication for control group.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Education, research and treatment center of Imam Reza (AS)
Full name of responsible person
Keyvan Aalizadeh,MD
Street address
Imam Reza Hospital, Daneshgah Avenue, Tabriz, East Azarbayejan, Iran
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chanscellor for research, Tabriz University of Medical Sciences
Full name of responsible person
Hassan Soleimanpour
Street address
Vice chanscellor for research, Tabriz University of Medical Sciences, Tabriz University of Medical Sciences, , Daneshgah Avenue, Tabriz, East Azarbayjan, Iran
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chanscellor for research, Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Keyvan Aalizadeh, MD
Position
Resident of Neurosurgery
Other areas of specialty/work
Street address
Neurosurgery Department Office, Imam Reza Hospital, Daneshgah Avenue, Tabriz, East Azarbayejan, Iran
City
Tabriz
Postal code
5166614756
Phone
+98 41 3334 0830
Fax
+98 41 3334 0830
Email
aalizadehkeyvan@ymail.com; mreza@tbzmed.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Javad Agazadeh, MD
Position
Associate Professor of Neurosurgery
Other areas of specialty/work
Street address
Neurosurgery Department Office, Imam Reza Hospital, Daneshgah Avenue, Tabriz, East Azarbayejan, Iran
City
Tabriz
Postal code
5166614756
Phone
+98 41 3334 0830
Fax
+98 41 3334 0830
Email
Javadagazadeh@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Keyvan Aalizadeh, MD
Position
Resident of Neurosurgery
Other areas of specialty/work
Street address
Neurosurgery Department Office, Imam Reza Hospital, Daneshgah Avenue, Tabriz, East Azarbayejan, Iran
City
Tabriz
Postal code
5166614756
Phone
+98 41 3334 0830
Fax
+98 41 3334 0830
Email
aalizadehkeyvan@ymail.com; mreza@tbzmed.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)