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The CDC estimates that the aggregate lifetime cost of traumatic brain injury in the U.S. is $56 billion per year. Evidence from animal studies suggests that progesterone has some neuroprotective qualities, including reducing cerebral edema and preventing neuronal loss, and that it improves functional outcomes. In a phase II randomized, double-blind, placebo-controlled trial, 100 adult patients who presented to an urban academic trauma center with head injury and Glasgow Coma Scale (GCS) scores of 4 to 12 were randomized in a 4:1 ratio to receive infusion of either progesterone or placebo for 3 days. Initiation of drug or placebo was delayed by a mean of 6 hours in both groups because of the time required to reach proxies for study consent.
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