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IRCT20180802040668N1 IRCT 2018-10-25 Mazandaran University of Medical Sciences The effect of oral simvastatin on the outcome of patients with severe traumatic brain injury The effect of oral simvastatin on the outcome of patients with severe traumatic brain injury 2018-10-08 anticipated 98 Complete https://irct.ir/trial/34256 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Single, Purpose: Treatment, Randomization description: In this study, the method of randomization and sequencing is simple and randomization software, and how it is sequenced in the same way, and the assigned group is not known before the assignment of the individual, Blinding description: In this plan, the main physician and the doctors of this article, as well as the patients involved in this project, health care units and nurses, data analyzers and authors of the article, the safety committee and data monitoring, are double blind. And the doctor who blinds and monitors and collects is aware of the subject. 3 Severe traumatic brain injury. Intervention 1: Intervention group: Intervention group: In addition to supportive therapies, daily treatment with simvastatin will be administered at a dose of 40 mg per day for 10 days. Intervention 2: Control group: In addition to the therapies that have been done so far, they will be placed under the placebo (lactose tablet). 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 No more information
public Sajad Shafiei
Imam Hospital, Razi Ave, Sari Town
Sari Iran (Islamic Republic of) 48166-33131 +98 113336700 sajad.shafiee@gmail.com Mazandaran University of Medical Sciences scientific Sajad Shafiei
Imam Hospital, Razi Ave, Sari Town
Sari Iran (Islamic Republic of) 48166-33131 +98 11 3336 1700 sajad.shafiee@gmail.com Mazandaran University of Medical Sciences Iran (Islamic Republic of) Patients with severe traumatic brain injury Non-use of corticosteroids and statins and NSAIDs Not having an allergy to statins Not having a history of autoimmune, cardio, respiratory, neuromuscular, liver or kidney disease 18 years 60 years Both Space-occupying lesion in the skull, including hematoma and ... GCS higher than 8 or GCS = 3 on admission Age> 60 and <18 years Syndrome organ trauma that requires surgical intervention. trauma of the limbs that requires surgical intervention. History of poisoning or drug use sepsis during the first 72 hours of admission Treatment - Drugs Treatment - Drugs Intervention group: Intervention group: In addition to supportive therapies, daily treatment with simvastatin will be administered at a dose of 40 mg per day for 10 days. Control group: In addition to the therapies that have been done so far, they will be placed under the placebo (lactose tablet). GCS, APACHEE2, ISS. Timepoint: The beginning of the study, Day 3 and Day 10 after starting treatment. Method of measurement: questionnaire. Mazandaran University of Medical Sciences Approved 2018-10-07 Ethic committee of Mazandaran University of Medical Sciences Imam Hospital, Razi Ave, Sari Town Sari Mazandaran Iran (Islamic Republic of)