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Brain Injury | A Study to Evaluate Progesterone in Patients With Moderate to Severe Head Trauma

In the latest development, the National Institutes of Health are expected to begin funding a study evaluating the hormone in more than 1,100 emergency patients with moderate to severe head trauma.

This study will get under way at 17 hospitals in 15 states around the U.S. and is expected to last up to five years at a projected cost of up to $28 million. It will be the pivotal study of whether the naturally occurring hormone progesterone, injected into patients within hours of severe accidents, can lower deaths and reduce paralysis and cognitive damage. It will be the definitive test of earlier animal research conducted over a quarter century by Emory University brain researcher Donald G.Stein.

"The extensive laboratory science and preliminary clinical research is highly promising, but not definitive," said David Wright, the Emory emergency-medicine doctor who will be principal investigator of the research. "This study is the ultimate test."

In recent years, various potential neurological treatments for stroke and brain injury have failed, such as the use in ambulances of high-concentration saline to relieve cranial pressure in brain-injury patients, and cooling procedures, or hypothermia, in pediatric brain-injury patients. These are only some of the latest disappointments in finding potential "neuro-protective" agents.

As a result, the idea that progesterone might be beneficial is greeted with both skepticism and considerable hope.

"Progesterone is one of the most exciting things we have coming out," said Lori Shutter, director of neurocritical care at the University of Cincinnati Hospital, one of the 17 study sites. "You can't undo the initial injury, but you hope to reduce the secondary injury, and progesterone may have a role in reducing the inflammatory process."

By Thomas M. Burton
Wall Street Journal
June 23, 2009
Excerpt from Brain-Trauma Study

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