Very Early Administration of Progesterone for Acute Traumatic Brain Injury

In this phase 3 trial, progesterone had no benefit as a neuroprotective agent in patients with blunt traumatic brain injury. Together with a second negative clinical trial of progesterone for acute TBI (SYNAPSE), the findings provide no support for this therapeutic approach. More than 2.4 million emergency department visits, hospitalizations, or deaths are related to traumatic brain injury (TBI) annually, and approximately 5.3 million Americans are living with disability from TBI. The aggregate annual cost of TBI in the United States now approaches $76.5 billion. 1 Survivors of severe TBI typically require 5 to 10 years of intensive therapy and are often left with substantial disability. 2 Despite decades of research, no pharmacologic agent has been shown to improve outcomes after TBI. Progesterone is a potent neurosteroid synthesized in the central nervous system. Preclinical studies in laboratory animals indicated that the early administration of . . .