University of California, San Francisco
The purpose of this study is to determine if experimental drug treatment improves recovery after TBI as compared to a control (placebo) group. Changes in recovery will be measured throughout the study. The study drug listed below is approved by the U.S. Food and Drug Administration (FDA) but is being used "off-label" in this study. This means that the drug is not currently approved to treat TBI.
Inclusion Criteria: 1. Adults (18-65 years of age, inclusive) 2. Head injury warranting clinical evaluation with a non-contrast cranial CT based on American College of Emergency Physicians (ACEP) Centers for Disease Control and Prevention (CDC) clinical policy for TBI imaging. 3. Able to receive investigational product within 24 hours of head injury. 4. Closest, prior to randomization GCS score of 3 to 12 (motor score \< 6) 5. Evidence of TBI on imaging, confirmed by: * Evidence of contusion and/or * Evidence of traumatic axonal microvascular injury (TAMVI) 6. Initial Glial Fibrillary…
Intravenous (IV) injection, loading dose of 2.5 mg/kg (diluted in 0.9% NaCl to a final volume of 50 ml) given over 2 hours, immediately followed by a continuous IV infusion of of 5 mg/kg/day (diluted in 0.9% NaCl to a final volume of 250 ml) for 3 days (72-hour).
Intravenous (IV) injection of 0.9% NaCl with the same dosing strategy as CsA: "loading dose" given over 2 hours, immediately followed by a continuous IV infusion for 3 days (72-hour).
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