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IRCT20210113050023N1 IRCT 2021-05-31 Ahvaz University of Medical Sciences The effect of atorvastatin administration on the outcome of patients with traumatic brain injury The effect of Atorvastatin administration on the outcome of patients with traumatic brain injury 2021-04-03 anticipated 60 Complete https://irct.ir/trial/53878 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, 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 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. 3 Brain Injury. Intervention 1: 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. Intervention 2: 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. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information.
public Esmaeil Alipour
Ahvaz Jundishapur University of Medical Sciences, GolestanBLvd
Ahvaz Iran (Islamic Republic of) 6135715794 +98 61 3373 8383 Dr.alipour37@gmail.com Ahvaz University of Medical Sciences scientific Esmaeil Alipour
Ahvaz Jundishapur University of Medical Sciences, GolestanBLvd
Ahvaz Iran (Islamic Republic of) 6135715794 +98 61 3373 8383 Dr.alipour37@gmail.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) 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 18 years 75 years Both 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) P11.2 Unspecified brain damage due to birth injury Prevention Prevention 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. 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. 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. 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. Ahvaz University of Medical Sciences Approved 2021-01-11 Ethics Committee of Ahwaz Jondishapour University Of Medical Sciences Ethics Committee of Ahwaz Jondishapour University Of Medical Sciences, Golestan Blvd., Ahwaz Ahvaz Khouzestan Iran (Islamic Republic of)