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IRCT20250803066738N1 IRCT 2025-08-07 Kerman University of Medical Sciences 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 Studying the effect of low-dose atorvastatin (10 mg) on plasma fibrinogen levels and white blood cell counts in patients with traumatic brain injury 2025-08-23 anticipated 70 Complete https://irct.ir/trial/85305 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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 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. 3 traumatic brain injury. Intervention 1: 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). Intervention 2: Control group: They will only receive standard treatment care during their hospitalization. Yes - There is a plan to make this available What will be shared: 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: 2 to 6 months after the statistical analysis of the data To whom: Researchers in the field of research and health Conditions: In order to use the results and during the written request Where to obtain: Saeed Karamouzian-Email (karamouzian@gmail.com) How to obtain: 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 Comments:
public Amin Soleimani Mohammadi
Qaraney St, Kerman, Kerman Province, Iran
Kerman Iran (Islamic Republic of) 761791111 +98 34 3223 5011 Soleimanyamin70@gmail.com Kerman University of Medical Sciences scientific Saeed Karamoziyan
Bahonar Hospital, Gharni Street, Kerman, Iran
Kerman Iran (Islamic Republic of) 7613747181 +98 34 3223 5011 karamouzian@gmail.com Kerman University of Medical Sciences Iran (Islamic Republic of) 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). 18 years no limit Both 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 S06.2 Diffuse traumatic brain injury Treatment - Drugs N/A 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 only receive standard treatment care during their hospitalization. Fibrinogen level. Timepoint: At the beginning of the study and 14 days later. Method of measurement: Blood test. White blood cell count. Timepoint: At the beginning of the study and 14 days later. Method of measurement: Blood test. Kerman University of Medical Sciences Approved 2025-08-04 Research Ethics Committees of Afzalipour Hospital - Kerman University of Medical sciences Clinical Research Development Unit, Afzalipour Hospital, Kerman University of Medical Sciences, Kerman, Iran Kerman Kerman Iran (Islamic Republic of)