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Study aim
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The effect of high dose of vitamin C on acute phase biomarker of cerebral S100B protein in patients with diffuse axonal brain injury
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Design
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Clinical trial with control group ,with parallel groups , double-blind ,randomised ,phase 3 on 90 patients.Patients are randomly divided into two groups based on RANDOM software.
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Settings and conduct
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Information of T.B.I patients referred to Poursina Medical Center in 1401 is registered.Drug and Placebo group recieve Vitamin C and Normal Salin respectively by continious infusion from C.V.C .
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Participants/Inclusion and exclusion criteria
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Adult patients aged 16 years and <60 years and moderate and severe head injury on the Glasgow Coma score of 4 to 12 (23) and acceptance with diagnosis of diffuse brain injury and S06.2 in the ICD-10 classification within the first 24 hours of injury and radiological diagnosis of diffuse axonal injury.
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Intervention groups
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Drug group will receive vitamin C in a dose of 10 g / 100 ml daily as a continuous infusion (4.166 ml per hour) for 7 days intravenously.Control group will receive normal salin in a dose of (100 ml daily with the same color and shape as the drug ) as a continuous infusion (4.166 ml per hour) for 7 days intravenously by central venous catether.
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Main outcome variables
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To evaluate the main consequence, The S100B protein level of blood samples was taken on the first, third and eighth day of hospitalization and after separating the serum in a freezer at -80 ° C and will be stored by the commercial kit until the S100B protein is measured. Treatment outcomes and complications including acute oxalate nephropathy (death, plant life, severe lower disability, upper severe disability, lower moderate disability, upper moderate disability, inferior good recovery, good upper functional recovery) were also present in the study groups at zero ,one and three months intervals and will be registered based on GOS score.