In this study we will investigate the effect low dose oral Atrovastatin on inflammatory factors in patients with traumatic brain injury
Design
Randomised controlled trial, parallel group design of 60 patients, double blind, single center
Settings and conduct
In this study, patients with traumatic brain injury admitted to intensive care unit of Golestan hospital of Ahvaz will be treated with oral atrovstatin. For blinding, patients and the individual who will select the envelopes and the data recorder will not be aware of the type of envelope grouping.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients age between 18 to 50 years with traumatic brain injury. Exclusion criteria: no consent to participate in the study; allergic reaction to Atrovastatin.
Intervention groups
The treatment group : Patients will receive a tablet of Atorvastatin 20mg daily in 2 week period
The control group : Patients will receive a tablet of Placebo daily in 2 week period
Main outcome variables
Patients are evaluated for leukocytosis, Leukocytopenia, duration of mechanical ventilation and hospitalization and level of inflammatory factors in intensive care units.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191016045127N1
Registration date:2020-01-12, 1398/10/22
Registration timing:prospective
Last update:2020-01-12, 1398/10/22
Update count:0
Registration date
2020-01-12, 1398/10/22
Registrant information
Name
Hamid Zarezadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3222 0168
Email address
zarezadeh.h@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-29, 1398/11/09
Expected recruitment end date
2020-03-09, 1398/12/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of low dose oral Atrovastatin on inflammatory factors in patients with Traumatic Brain Injury (TBI)
Public title
Effect of oral Atrovastatin on inflammatory factors in patients with traumatic brain injury
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18 to 50 years old
Patents with traumatic brain injury
Exclusion criteria:
patient’s lack of consent
Having allergy to Atrovastatin
Age
From 18 years old to 50 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, a simple randomization method is used. Randomization unit is individual and the tool used to randomize is the closed envelope. Inside each envelope is the English letter A or B. Patients fall into the intervention or placebo group according to the word that came out of the envelop.
Blinding (investigator's opinion)
Double blinded
Blinding description
None of the patients and the individual who will select the envelopes, know the type of envelope grouping.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz Jondishapour University of Medical Sciences
Street address
No. 5, Ahvaz Jondishapour University of Medical Sciences Ave., University Blvd., Ahvaz Town,
City
Ahvaz
Province
Khouzestan
Postal code
6401356874
Approval date
2019-11-08, 1398/08/17
Ethics committee reference number
IR.AJUMS.REC.1398.589
Health conditions studied
1
Description of health condition studied
Traumatic Brain Injury
ICD-10 code
S06.1
ICD-10 code description
Traumatic cerebral edema
Primary outcomes
1
Description
leukocytosis
Timepoint
Days 1, 7, 10 and 15 after treatment
Method of measurement
Blood samples will be taken from patients and the values of White Blood Cells will be recorded in the checklist.
2
Description
Leukocytopenia
Timepoint
Days 1, 7, 10 and 15 after treatment
Method of measurement
Blood samples will be taken from patients and the values of White Blood Cells will be recorded in the checklist.
3
Description
Duration of Mechanical Ventilation
Timepoint
During Intervention
Method of measurement
Day
4
Description
hospitalization
Timepoint
During Intervention
Method of measurement
Day
5
Description
Inflammatory Factors
Timepoint
15 days after treatment
Method of measurement
Blood samples are taken from patients and the amount of inflammatory factors determined in the laboratory and will be recorded in the checklist.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients will receive a tablet of Atorvastatin 20mg daily in 2 week period.
Category
Treatment - Drugs
2
Description
Control group: Patients will receive a tablet of placebo daily in 2 week period.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Golestan Hospital
Full name of responsible person
Hamid Zareh Zadeh
Street address
No 5, Farvardin blvd, Golestan highway, Ahvaz Town,
City
Ahvaz
Province
Khouzestan
Postal code
610435896
Phone
+98 61 3374 3018
Email
zarezadeh.h@ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Saeid Ahmad Hosseini
Street address
No. 5, Ahvaz Jondishapour University of Medical Sciences Ave., University Blvd., Ahvaz Town,
City
Ahvaz
Province
Khouzestan
Postal code
610435896
Phone
+98 61 3374 3018
Email
hosseini.a@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Vice chancellor for research of Ahwaz Jundishapour university of medical science
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Foreign
Category of foreign source of funding
Sponsor: country of origin
Country of origin
IR
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
Hamid Zareh Zadeh
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
No 5, Farvardin blvd, Golestan highway, Ahvaz Town,
City
Ahvaz
Province
Khouzestan
Postal code
610435896
Phone
+98 61 3374 3018
Email
zarezadeh.h@ajums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Hamid Zareh Zadeh
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
No 5, Farvardin blvd, Golestan highway, Ahvaz Town,
City
Ahvaz
Province
Khouzestan
Postal code
610435896
Phone
+98 61 3374 3018
Email
zarezadeh.h@ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Hamid Zareh Zadeh
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
No 5, Farvardin blvd, Golestan highway, Ahvaz Town,
City
Ahvaz
Province
Khouzestan
Postal code
610435896
Phone
+98 61 3374 3018
Email
zarezadeh.h@ajums.ac.ir
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
The information of the patients studied in our study is completely private and cannot be published