Determining the effect of amantadine on the recovery of patients with traumatic brain injury
Design
clinical trial with an intervention group, with a parallel group; Three-blind, phase 3, sample size 102, randomized using block method
Settings and conduct
This study is conducted in Imam Reza Birjand Hospital, South Khorasan Province. 102 patients are divided into two intervention groups one or two (A-B) in a simple random manner. Glasgow Coma Criteria will be evaluated before the intervention and 3 and 7 days after the intervention.
Participants/Inclusion and exclusion criteria
Our study population will be patients with traumatic brain injury whose GCS ≤ 8 admitted to the Neurosurgery ICU of Imam Reza (AS) Birjand Hospital in 1401.
Inclusion criteria
1) Age more than 16 years
2) Glasgow coma criteria less than 8
3) The possibility of receiving medicine through NG or OG tube
4) Obtaining consent from the patient to enter the study after he regains consciousness and recovers
Exclusion criteria
1. Pregnancy
2. Diabetes disease,
blood fat
3. Cancer
4. Congenital, ischemic and atherosclerotic heart disease
5. Kidney failure
6. Patients with unknown identity
7. Kidney disease
8. Use of dopanergic agents by the patient
9. Amantadine is a contraindication.
Intervention groups
Intervention groups: Group A will receive amantadine 100 mg twice a day (at 8 am 8 pm) for 6 weeks and control group B will receive a placebo containing fructose for 6 weeks.
Main outcome variables
Glasgow Coma Scale
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190618043934N18
Registration date:2023-07-14, 1402/04/23
Registration timing:prospective
Last update:2023-07-14, 1402/04/23
Update count:0
Registration date
2023-07-14, 1402/04/23
Registrant information
Name
Zabihullah Mohaghegh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 56 3232 3232
Email address
oabstudent@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-22, 1402/05/31
Expected recruitment end date
2024-02-19, 1402/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of amantadine on the recovery of patients with severe brain injury: a randomized controlled clinical trial
Public title
The effect of amantadine on the recovery of patients with traumatic brain injury
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age more than 16 years
GCS≤8
Possibility of receiving medicine through NG or OG tube
Obtaining consent from the patient to enter the study after she regains consciousness and recovers(مؤنث)
Exclusion criteria:
Pregnancy
Diabetes disease
Dyslipidemia
Cancer
Congenital, ischemic and atherosclerotic heart disease
Kidney failure
Patients with unknown identity
Kidney disease
Use of dopanergic agents by the patient
Contraindications for the use of amantadine
Age
From 16 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
51
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are divided into two groups by simple randomization and block method: 1. Amantadine recipient (A) and 2. Placebo recipient (B). The selection and placement of patients in two groups will be simple random and blocked in a closed and sealed envelope. In this way, various quadruple blocks are created first (AABB, BBAA, ABAB, BABA, ABBA and BABA). One of these blocks will be randomly selected and the patients will be divided into one of two groups A or B. Then randomization is done for other patients as well.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Participant in the study: due to the fact that the patients are not conscious, they will not know about the prescribed medicine for them.
Outcome evaluator: The study administrator, without knowing the type of drug received, asks questions from the patients and records them in the relevant checklist.
Analyst: The person who is responsible for data analysis will not know about the placement of patients in each group and the data will be analyzed blindly.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Birjand University of Medical Sciences
Street address
Vice Chancellor for Research and Technology, Birjand University of Medical Sciences, Ghaffari Blvd, Birjand Town
City
Birjand
Province
South Khorasan
Postal code
9717811674
Approval date
2022-07-24, 1401/05/02
Ethics committee reference number
IR.BUMS.REC.1401.179
Health conditions studied
1
Description of health condition studied
brain injury
ICD-10 code
S06.2
ICD-10 code description
Diffuse traumatic brain injury
Primary outcomes
1
Description
Glasgow Coma Scale
Timepoint
First and before the intervention, the third day of the intervention and the seventh day of the intervention
Method of measurement
Using the Glasgow coma criteria table and clinical examination by a neurosurgery assistant
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The first intervention group: Group A receiving amantadine 100 mg twice a day (8:00 a.m. to 8:00 p.m.) for 6 weeks.
Category
Treatment - Drugs
2
Description
Control group: The first control group: Group B receiving placebo containing fructose for 6 weeks.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Birjand Hospital
Full name of responsible person
Zabihullah Mohaqiq
Street address
School of Medicine, Birjand University of medical sciences, Ghahhari Blvd,
City
Birjand
Province
South Khorasan
Postal code
9717934888
Phone
+98 915 104 6738
Email
zabihullahmohaghegh@gmail.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Dr Mohammadreza Miri
Street address
Vice Chancellor for Research and Technology, Birjand University of Medical Sciences, Ghaffari Blvd, Birjand Town
City
Birjand
Province
South Khorasan
Postal code
9717811674
Phone
+98 915 104 6738
Email
research@bums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Birjand 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
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Zabihullah Mohaqiq
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
General Practitioner
Street address
School of Medicine, Birjand University of medical sciences, Ghahhari Blvd, Birjand Town
City
Birjand
Province
South Khorasan
Postal code
9717934888
Phone
+98 56 3232 3232
Email
oabstudent@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Dr Kazem Ghaemi
Position
Member of the Faculty
Latest degree
Subspecialist
Other areas of specialty/work
Neurosurgery
Street address
School of Medicine, Birjand University of medical sciences, Ghahhari Blvd, Birjand Town
City
Birjand
Province
South Khorasan
Postal code
9717811674
Phone
+98 56 3232 3232
Email
oabstudent@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Zabihullah Mohaqiq
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
General Practitioner
Street address
School of Medicine, Birjand University of medical sciences, Ghahhari Blvd,
City
Birjand
Province
South Khorasan
Postal code
9717934888
Phone
+98 56 3232 3232
Email
zabihullahmohaghegh@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no need to publish individual patient information
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