Progesterone shows promise as treatment for traumatic brai...( reatment of TBI. Their three-year pilot...),Health

reatment of TBI. Their three-year pilot study, called ProTECT (which stands for "Progesterone for Traumatic brain injury--Experimental Clinical Treatment"), enrolled 100 participants. Their phase II study was primarily designed to evaluate whether progesterone can be administered intravenously in a reliable way, and whether the treatment is safe to use in humans with TBI. The researchers also hoped to find preliminary evidence that the treatment might be effective.

Although it is widely considered a "sex steroid," progesterone is also a neurosteroid that exerts protective effects on human tissue. It is naturally present in small but measurable amounts in the brains of males and females. Laboratory studies suggest that progesterone is critical for the normal development of neurons in the brain and exerts protective effects on damaged brain tissue.

Study participants were enrolled at Grady Memorial Hospital (the site of the study because it is Atlanta's only Level 1 Trauma Center). To be a candidate for the study, patients had to reach the hospital within 11 hours of injury. People enrolled in the study had a "blunt" traumatic brain injury, which typically occurs from a car accident, motorcycle crash or a fall. Enrolled patients had an initial Glasgow Coma Scale (GCS) score ranging between 4 and 12. The GCS is a widely used scale that quantifies the initial level of impairment from a TBI. A score of 4-8 signals severe TBI, usually accompanied by coma, while a score of 8-12 signals a moderate TBI.

Because study candidates were cognitively impaired, their family members or other legal representatives were asked to give proxy consent for enrollment in the study. Four out of every five patients (80 percent) enrolled received intravenous progesterone, and one of every five (20 percent) received placebo. Patients, family members, doctors nor study staff knew which participants received progesterone or placebo until the study was completed. Thi
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Contact: Janet Christenbury
jmchris@emory.edu
404-727-8599
Emory University Health Sciences Center
2-Oct-2006

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