Improved outcomes from the administration of progesterone for patients with acute severe traumatic brain injury: a randomized controlled trial

BACKGROUND Severe traumatic brain injury (TBI) has been increasing with greater incidence of injuries from traffic or sporting accidents. Although there are a number of animal models of TBI using progesterone for head injury, the effects of progesterone on neurologic outcome of acute TBI patients remain unclear. The aim of the present clinical study was to assess the longer-term efficacy of progesterone on the improvement in neurologic outcome of patients with acute severe TBI. METHODS A total of 159 patients who arrived within 8 hours of injury with a Glasgow Coma Score 0.05). Instances of complications and adverse events associated with the administration of progesterone were not found. CONCLUSION Our data suggest that acute severe TBI patients with administration of progesterone hold improved neurologic outcomes for up to 6 months. These results provide information important for further large and multicenter clinical trials on progesterone as a promising neuroprotective drug. TRIAL REGISTRATION ACTRN12607000545460.