effectivness of amantadine hydrocholoride on functional recovery in sever traumatic brain injery
Design
This study was conducted in a randomized clinical trial on 60 patients with brain trauma.
Settings and conduct
This study will be carried out at Tabriz Imam Hospital in a three-blind manner, only the head nurse will be aware of it, and the researcher and the patient and Analzor will be unaware of it.
Participants/Inclusion and exclusion criteria
Criteria for entering the study:
1- Patients aged 18 to 65 years
2. People who have not had a known illness before head injury.
3. The subject matter of the dispute shall provide his written consent on his behalf
Exit criteria:
People with severe cardiovascular disease or congestive heart failure, myocardial infarction, persistent spinal cord injury, cancer, or any other severe disease that affects the evaluation of treatment.
People with chronic steroid therapy
Individuals received any other drug within 30 days of injury.
Significant TBI, brain tumor, cerebrovascular event, or other persistent brain illusions
Intervention groups
Patients aged 18 to 65 years with severe brain trauma will receive twice daily Amantadine 100 mg daily after an accident, and this dose will continue for 11 days. At week 3, the dose will be increased to 150 mg twice a week and at week 4 to 200 mg twice a week.
Main outcome variables
Mini-mental Status Test (MMSE) for patients with severe acute traumatic brain injury
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120527009878N7
Registration date:2019-05-16, 1398/02/26
Registration timing:prospective
Last update:2019-05-16, 1398/02/26
Update count:0
Registration date
2019-05-16, 1398/02/26
Registrant information
Name
Firooz Salehpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3334 0830
Email address
salehpourf@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-16, 1398/03/26
Expected recruitment end date
2019-09-01, 1398/06/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
effectivness of amantadine hydrocholoride on functional recovery in sever traumatic brain injery
Public title
effectivness of amantadine hydrocholoride on functional recovery in sever traumatic brain injery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1- Patients aged 18 to 65 years
2. Those who have not had a known disease prior to head injury.
3. The supervisor will provide his written consent on his behalf
Exclusion criteria:
1-People with severe cardiovascular disease or congestive heart failure, myocardial infarction, persistent spinal cord injury, cancer, or any other severe disease that affects the evaluation of treatment.
2-People with chronic steroid therapy
3-Individuals received any other drug within 30 days of injury.
4-Significant TBI, brain tumor, cerebrovascular event, or other persistent brain illusions
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
The accident will be the case with two boxes, each containing blue and red cards, one of which represents a placebo and the other representing Amantadine, and only the head nurse of Tabriz Imam Resa Hospital and the medical staff of This will be known and will place one of the colored stickers in the patient's case. Three months later, the examiner will examine the patient without notifying which treatment method has been chosen and will record the patient's radiological criteria.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The selected patients will be divided into two groups of placebo recipients and amantadine recipients based on the color of the card, which the head nurse will be informed of. The next month, the examiner examined the patient without knowing which treatment method was selected, and the radiological criteria It will be recorded for the patient, which is also a type of treatment methodology, and therefore on this basis, the study will be blinded to three parts, and after the analysis, the head and nurse will be asked the type of blue and red method.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tabriz Medical School
Street address
Azadi Ave , Golghast St , Imam Reza Hospital
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Approval date
2019-05-07, 1398/02/17
Ethics committee reference number
IR.TBZMED.REC.1398.121
Health conditions studied
1
Description of health condition studied
Level of consciousness and cognitive function in patients with trauma
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Mini-mental Status Test (MMSE) scoring for patients with severe acute trauma
Timepoint
During surgery and duration of hospitalization after surgery
Method of measurement
Check out the Mini-mental Status Test (MMSE) table.
2
Description
Disability Rating Scale (DRS) scoring for patients with severe acute traumatic brain injury
Timepoint
During surgery and duration of hospitalization after surgery
Method of measurement
Disability Rating Scale (DRS) Score
3
Description
Glasgow Outcome Scale Scoring (GOS) for patients with severe acute traumatic brain injury
Timepoint
During surgery and duration of hospitalization after surgery
Method of measurement
Check Glasgow Outcome Scale Table (GOS)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients aged 18 to 65 years with severe brain trauma will receive twice daily Amantadine 100 mg once a day, and this dose will continue for 11 days. At week 3, the dose will be increased to 150 mg twice a week and week 4 to 200 mg twice weekly.
Category
Treatment - Drugs
2
Description
Control group: Patients aged 18 to 65 years with severe brain trauma will receive placebo once a day after an accident at a dose of 100 mg of amantadine twice daily and will continue for 11 days. At week 3, the dose will be increased to 150 mg twice a week and at week 4 to 200 mg twice a week.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Ahsan Rahimi
Street address
Azadi St., Golghast St
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 44 1333 8507
Email
mshimiya@yahoo.com
Web page address
https://imamreza.tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mohammad Shimia
Street address
Azadi St., Golghast St
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 44 1446 9326
Email
Mshimia@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Moslem Shakeri
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
Golgasht ave
City
ُTabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 44 1333 8507
Email
shakerim@tbzmed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Ahsan Rahimi
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Neurosurgery
Street address
Golgasht ave
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 44 1343 8707
Email
Rahimiahsan@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Ahsan Rahimi
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Neurosurgery
Street address
Golgasht ave
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 44 1333 8507
Email
ahimiahsan@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available