The aim is Studying the effect of low-dose atorvastatin (10 mg) on plasma fibrinogen levels and white blood cell counts in patients with traumatic brain injury.
Design
A 2-arm, parallel-group clinical trial (including groups: A- Atorvastatin 10 mg orally, B- Control receiving standard treatments), double-blind, randomized, phase 3 on 70 patients. Random number generation software is used to assign patients to the two groups.
Settings and conduct
Place of conduct: ICU ward of Bahonar Hospital, Kerman. The drugs will be given orally or via NGT. This study is double-blind, in which both the patient's guardian or legal guardian and the researchers who are responsible for recording the data and evaluating the outcomes are unaware of the type of treatment.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Diagnosis of mild to severe traumatic brain injury.
Admission to the ICU for at least 72 hours.
No use of atorvastatin in the 3 months prior to admission.
No history of liver disease or elevated liver enzymes (ALT/AST > 3 times normal).
Exclusion criteria: Concomitant use of drugs that interact with atorvastatin .
Patients with GCS ≤ 3
History of hypersensitivity to atorvastatin.
History of statin-induced myopathy or rhabdomyolysis.
TBI due to suicide or non-accidental injuries.
Need for emergency surgery other than craniotomy (e.g., abdominal or thoracic surgery).
Receiving potent anti-inflammatory drugs in the 7 days prior to the study.
Intervention groups
Intervention group: they will receive standard care for treatment during the hospitalization period, as well as atorvastatin 10 mg orally or via NG tube from the first day of hospitalization until discharge from the ICU (or a maximum of 14 days).
Control group: they will receive only standard care for treatment during the hospitalization period.
Main outcome variables
Fibrinogen levels, white blood cell count
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20250803066738N1
Registration date:2025-08-07, 1404/05/16
Registration timing:prospective
Last update:2025-08-07, 1404/05/16
Update count:0
Registration date
2025-08-07, 1404/05/16
Registrant information
Name
amin Soleimani Mohammadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3223 5011
Email address
soleimanyamin70@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-08-23, 1404/06/01
Expected recruitment end date
2026-03-20, 1404/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Studying the effect of low-dose atorvastatin (10 mg) on plasma fibrinogen levels and white blood cell counts in patients with traumatic brain injury
Public title
Studying the effect of low-dose (10 mg) lipid-lowering drug administration on plasma levels of coagulation factors and white blood cells in patients with traumatic brain injury
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of traumatic brain injury (TBI) of mild to severe severity (based on GCS).
ICU admission for at least 72 hours (to ensure adequate monitoring).
No use of atorvastatin in the 3 months prior to hospitalization.
No history of liver disease or elevated liver enzymes (ALT/AST > 3 times normal).
Exclusion criteria:
Concomitant use of drugs that interact with atorvastatin (such as some antibiotics, antifungals).
Patients with GCS ≤ 3
History of allergy to atorvastatin or any statin.
History of statin-induced myopathy or rhabdomyolysis.
TBI caused by suicide or non-accidental injuries (for moral and psychological reasons).
Need for emergency surgery other than craniotomy (e.g., abdominal or thoracic surgery).
Receiving strong anti-inflammatory medications (such as high-dose corticosteroids) within 7 days prior to the study
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
For this purpose, a block randomization method with blocks of 4 and an allocation ratio of 1:1 is used to maintain balance between groups. Patient allocation is performed using random number generation software (such as R or SPSS) and recorded in sealed envelopes to ensure allocation concealment. All randomization steps are recorded and reported in accordance with CONSORT guidelines.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study was double-blind, meaning that both the patient's legal guardian and the researchers responsible for recording data and evaluating outcomes were unaware of the type of treatment the patients received and the details of the treatment, such as the type of medication used. It is worth noting that the consenter is not aware of the group in which his or her patient is placed, and only the neurosurgeon will be aware of the type of medication and treatment so that he or she can provide appropriate care and respond appropriately in the event of complications or problems.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Afzalipour Hospital - Kerman University of Medical sciences
Street address
Clinical Research Development Unit, Afzalipour Hospital, Kerman University of Medical Sciences, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616913911
Approval date
2025-08-04, 1404/05/13
Ethics committee reference number
IR.KMU.AH.REC.1404.094
Health conditions studied
1
Description of health condition studied
traumatic brain injury
ICD-10 code
S06.2
ICD-10 code description
Diffuse traumatic brain injury
Primary outcomes
1
Description
Fibrinogen level
Timepoint
At the beginning of the study and 14 days later
Method of measurement
Blood test
2
Description
White blood cell count
Timepoint
At the beginning of the study and 14 days later
Method of measurement
Blood test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: they will receive standard care for treatment during the hospitalization period, as well as atorvastatin 10 mg orally or via NG tube from the first day of hospitalization until discharge from the ICU (or a maximum of 14 days).
Category
Treatment - Drugs
2
Description
Control group: They will only receive standard treatment care during their hospitalization.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Bahonar Hospital, Kerman
Full name of responsible person
Shahab Ilka
Street address
Shahid Bahonar Hospital, Qarni Street , Kerman,
City
Kerman
Province
Kerman
Postal code
7613747181
Phone
+98 34 3223 5011
Email
bahonarh@kmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Abedin Iranpour
Street address
Deputy for Research and Technology, Beginning of Ibn Sina Street,Somayeh Crossroads (Tahmaseb Abad), Iran, Kerman,
City
Kerman
Province
Kerman
Postal code
7619813159
Phone
+98 34 3226 3719
Email
VCR@KMU.AC.IR
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Amin Soleimani Mohammadi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Neurosurgery
Street address
Qaraney St, Kerman, Kerman Province, Iran
City
Kerman
Province
Kerman
Postal code
761791111
Phone
+98 34 3223 5011
Fax
Email
Soleimanyamin70@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Saeed Karamoziyan
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
Bahonar Hospital, Gharni Street, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7613747181
Phone
+98 34 3223 5011
Fax
Email
karamouzian@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Amin Soleimani Mohammadi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Neurosurgery
Street address
Qaraney St, Kerman, Kerman Province, Iran
City
Kerman
Province
Kerman
Postal code
761791111
Phone
+98 34 3223 5011
Fax
Email
Soleimanyamin70@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
At the end of the study, some of the information, including the effect of low-dose atorvastatin (10 mg) administration on plasma fibrinogen levels and white blood cell counts in patients with traumatic brain injury, will be shared with healthcare professionals after de-identification.
When the data will become available and for how long
2 to 6 months after the statistical analysis of the data
To whom data/document is available
Researchers in the field of research and health
Under which criteria data/document could be used
In order to use the results and during the written request
From where data/document is obtainable
Saeed Karamouzian-Email (karamouzian@gmail.com)
What processes are involved for a request to access data/document
Purpose of access and use of data, request to e-mail E-mail to the author, second e-mail in case of no response as a reminder, confirmation of the applicant's identity by the general respondent, sending the documentation file