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IRCT20141116019971N6 IRCT 2022-06-26 Shahid Beheshti University of Medical Sciences Atorvastatin in acute intracerebral hemorrhage. The effect of Atorvastatin on the blood-brain barrier biomarkers in acute intracerebral hemorrhage, a pilot clinical trial. 2022-07-23 anticipated 92 Complete https://irct.ir/trial/63960 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block random sampling will be used. In the present study, there are two groups (intervention group and control group). Therefore, four blocks will be used. According to the sample size (92 people in total, 46 in each group), 23 blocks of four will be considered. The random allocation of individuals to the group's understudy will be done as follows: First, there will be 23 envelopes containing four cards with A, B, C, and D Latin letters, the letters A and B will be the intervention group, the letters C and D will be considered as the control group. According to the inclusion criteria, the patients would randomly choose one of the 23 sealed envelopes and select a random card from the inside, which is based on the card's label that determines the allocation of the individual to either of the two study groups, Blinding description: In this study, participants and the individual who evaluates the outcome are unaware of the allocation of drugs and placebo. Before starting a medication, it will be explained to each patient that ،they will be treated with a tablet orally. But the patients do not know what medicine they have received. The physician is a neurological assistant who is not involved in the study design, interventions, and specific objectives under study. 3 Intracerebral Hemorrhage. Intervention 1: Intervention group:Tab Atorvastatin 40 mg per day will be administered for 45 days. In addition, routine medical treatment including antihypertensive drugs will be given to the patients. Intervention 2: Control group: this group only will receive routine treatment for intracranial hemorrhage, including antihypertensive drugs. Yes - There is a plan to make this available What will be shared: upon completion of the study, Individual participant data (anonymous) comprising age, gender, pain intensity, and vital signs will be released. When: Access to the information starts in 2023. To whom: All researchers have the possibility to access the data regardless of the research field. Conditions: There is no specific criteria for data access. Where to obtain: To request data access, please contact to Dr Ehsan Karimi. E-mail: drkarimi86@gmail.com, Phone number: 00989122493628, Address: Sina hospital, Imam Khomeini Avenue. How to obtain: Upon contact, data will be sent by email. Comments:
public Ehsan Karimialavijeh
Sina Hospital, Imam Khomeini Avenue, Hasan Abad Square
Tehran Iran (Islamic Republic of) 1136746911 +98 21 6634 8500 drkarimi86@gmail.com Tehran University of Medical Sciences scientific Ehsan Karimialavijeh
Sina Hospital, Hasan abad Square, Imam Khomeini Avenue,
Tehran Iran (Islamic Republic of) 1136746911 +98 21 6634 8500 drkarimi86@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Age < 80 years. Intracerebral hemorrhage confirmed by ذrain CT scan without contrast. low-density lipoprotein (LDL) level >40 mg/dL. no limit 80 years Both Pregnancy. Coma at the time of admission. History of neurodegenerative disorders such as Alzheimer's disease, Multiple sclerosis, Parkinson's disease, previous stroke, and psychological problems. History of brain tumors. Intracerebral hemorrhage due to vascular malformation or coagulation disorders. Intracerebral hemorrhage which requires surgical evacuation. I61.2 Nontraumatic intracerebral hemorrhage in hemisphere, unspecified Treatment - Drugs Treatment - Drugs Intervention group:Tab Atorvastatin 40 mg per day will be administered for 45 days. In addition, routine medical treatment including antihypertensive drugs will be given to the patients. Control group: this group only will receive routine treatment for intracranial hemorrhage, including antihypertensive drugs. Serum level of Matrix metallopeptidase 9. Timepoint: At the time of admission (before intervention) and after 14 and 45 days of Atorvastatin consumption. Method of measurement: Blood Sample. Serum level of Vascular endothelial growth factor. Timepoint: At the time of admission (before intervention) and after 14 and 45 days of Atorvastatin consumption. Method of measurement: Blood Sample. Shahid Beheshti University of Medical Sciences Approved 2020-12-29 Ethics committee of Shahid Beheshti University of Medical Sciences Velenjak street, Shahid Chamran highway Tehran Tehran Iran (Islamic Republic of)