The aim of this study was to evaluate the effect of atorvastatin administration on the outcome of patients with traumatic brain injury.
Design
Sixty patients with brain injury will be included in the study and will be divided into two groups of intervention and control (including 30 patients in each group) in parallel and randomized groups through a table of random numbers. The blinding in this study will be that the nurse prescribing the drug and evaluating the outcome and analyzing the statistical data will not know which group the patients fall into.
Settings and conduct
This double-blind clinical trial study will be performed in Ahvaz Golestan Hospital. In the intervention group, atorvastatin was administered at a daily dose of 20 mg for 10 days. In the control group, the patient will receive a 20 mg placebo tablet every 12 hours for ten days. The blinding in this study will be that the nurse prescribing the drug and evaluating the outcome and analyzing the statistical data will not know which group the patients fall into.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Patients with moderate severity GCS = 9-13 and severe GCS = 5-8, Patients with size of brain contusions less than 30 CC according to the initial CT-scan of the brain, No history of taking statins
Exclusion criteria: Patients with a score of 4 and GCS 3, Grade IV on primary brain CT scan or brain lesions, Patients with severe damage to other internal organs, or spinal cord injury, History of anticoagulants
Intervention groups
In the intervention group, atorvastatin with a daily dose of 20 mg (manufactured by RAHA Iran) will be prescribed for 10 days. The intervention will begin less than 10 hours after the injury. In the control group, the patient will receive a 20 mg placebo tablet every 12 hours for ten days.
Main outcome variables
Patients' functional recovery rate using GOS and DRS criteria
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210113050023N1
Registration date:2021-05-31, 1400/03/10
Registration timing:registered_while_recruiting
Last update:2021-05-31, 1400/03/10
Update count:0
Registration date
2021-05-31, 1400/03/10
Registrant information
Name
Esmaeil Alipour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3571 5794
Email address
dr.alipour37@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-03, 1400/01/14
Expected recruitment end date
2021-07-05, 1400/04/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Atorvastatin administration on the outcome of patients with traumatic brain injury
Public title
The effect of atorvastatin administration on the outcome of patients with traumatic brain injury
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with moderate (GCS = 9.13) and severe (GCS = 8.5) brain trauma injuries based on GCS score
Patients with size of brain contusions less than 30 CC according to the initial CT-scan of the brain
No history of statins
Patients who arrived at the hospital less than 10 hours after the injury
their legal representative (guardian or trustee) will be present to receive the consent
Exclusion criteria:
Patients with GCS scores of 4 and 3
Patients with Grade IV on primary brain scan or CT scan
Patients with severe damage to other internal organs or spinal cord injury
History of kidney or liver disease
Creatine>2.5 mg/dl
History of brain tumor, stroke
History of infection
Previous craniotomy
Pregnant and lactating women
Patients with systolic blood pressure less than 90 mm Hg
History of taking low-molecular-weight anticoagulants such as aspirin, wafarin, or heparin (7 days before hospitalization)
Age
From 18 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Patients with brain injury will be selected by census according to the inclusion criteria and randomly divided into two groups A and B using a table of random numbers so that by moving the researcher's hand up and down in the table of random numbers, Even numbers will be assigned to group A (Atorvastatin group) and odd numbers to group B (placebo group).
Blinding (investigator's opinion)
Double blinded
Blinding description
Due to the double-blindness of the study, the nurse did not know whether the pill he was giving the patient was a placebo or an Atorvastatin pill (due to the similarity of the two pills), and the nurse who recorded the results was unaware that the patients were in the study or control group. The statistical analyzer was also unaware of the type of grouping and prescriptive judgment. The researcher selected the drug and divided it into containers A and B, respectively, and gave it to the nurse for gavage, so the nurse did not know whether the drug was a placebo or not.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Ahwaz Jondishapour University Of Medical Sciences
Street address
Ethics Committee of Ahwaz Jondishapour University Of Medical Sciences, Golestan Blvd., Ahwaz
City
Ahvaz
Province
Khouzestan
Postal code
61357157941
Approval date
2021-01-11, 1399/10/22
Ethics committee reference number
IR.AJUMS.REC.1399.826
Health conditions studied
1
Description of health condition studied
Brain Injury
ICD-10 code
P11.2
ICD-10 code description
Unspecified brain damage due to birth injury
Primary outcomes
1
Description
The score calculated from the GOS benchmark in relation to the patient's life condition
Timepoint
Daily until 3 months later
Method of measurement
GOS criteria
2
Description
The score calculated from the DRS measurement criterion in relation to the patient's state of consciousness and function
Timepoint
Daily until 3 months later
Method of measurement
DRS criteria
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the intervention group, in addition to receiving routine care (daily intake of vitamins C and D and E and regulation of sodium, calcium and potassium electrolytes and daily gavage nutrition) of atorvastatin tablets with a daily dose of 20 mg (made by RAHA Iran) every 12 hours to It will be prescribed for 10 days. The intervention will begin less than 10 hours after the injury.
Category
Prevention
2
Description
Control group: In the control group, in addition to receiving routine care (daily intake of vitamins C and D and E and regulation of sodium, calcium and potassium electrolytes and daily gavage nutrition) placebo 20 mg tablet (administered by the Department of Pharmacy of Ahvaz Jundishapur University of Medical Sciences in the same way Atorvastatin tablets will be taken every 12 hours for ten days.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Golestan hospital
Full name of responsible person
Esmaeil Alipour
Street address
Ahvaz., Golestan Blvd., Golestan hospital., Intensive Care Unit
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8383
Email
dr.alipor37@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mehdi Ahmadi Moghadam
Street address
Vice Chancellor For Research of Ahvaz Jundishapour University of Medical Sciences, Ground Floor, Central Library, Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8383
Email
ahmadi-m@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Esmaeil Alipour
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Ahvaz Jundishapur University of Medical Sciences, GolestanBLvd
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8383
Email
Dr.alipour37@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Esmaeil Alipour
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Ahvaz Jundishapur University of Medical Sciences, GolestanBLvd
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8383
Email
Dr.alipour37@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Esmaeil Alipour
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Ahvaz Jundishapur University of Medical Sciences, GolestanBLvd
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8383
Email
Dr.alipour37@gmail.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