Brain research sought for trauma center

AUSTIN (KXAN) - Emergency room doctors at University Medical Center Brackenridge are pushing groups like the Austin City Council to endorse new research on traumatic brain injuries for patients who cannot consent to treatment.

If approved by the council and other groups, it would put the burden on Austin residents to opt out of the clinical research trial if they do not want to be a part of the studies, which are known as ProTECT and EPO .

The research would allow doctors to use clinical treatments to help reduce the amount of brain damage and swelling after a traumatic injury to the brain.

A vote of approval from Austin's City Council would help satisfy a federal requirement for "community consent," which is a federal requirement to initiate an experimental study in patients that cannot give informed consent prior to treatment. A memo in this week's Council agenda also notes the project will have no fiscal impact on the city budget.

Doctors would ultimately have to get approval from an Institutional Research Board for the research.

UMC Brackenridge's Emergency Department is looking implement two research studies designed to see if progesterone or erythropetin, natural hormones, can reduce brain swelling and damage.

Early studies with progesterone have shown promise to save lives.

"The government wouldn't have approved this study if the benefits didn't far outweigh the risks," said Dr. Alex Valadka, who would help conduct the research at UMC Brackenridge. 

Doctors from Seton Family of Hospitals presented facts to a city council council subcommittee last week that said traumatic brain injury takes place 1.5 million times in the United States, resulting in 50,000 deaths every year.

"As far as pharmaceutical intervention, we really haven't found the magic bullet," Dr. Truman Milling, director of clinical research of Emergency Departments at UMC Brackenridge and Dell Children's

The treatment would help treat what doctors at UMC Brackenridge call a silent epidemic.

"People who have brain injuries deserve to have research done to make the management of head injuries go better in the future," said Dr. Christopher Ziebell, head of the UMC Brackenridge Emergency Department. "We think the benefit is likely to be there, but of course, we'll be watching very closely."

The community consent process is required for the experimental research by the Food and Drug Administration.

Ziebell and Valadka said doctors will talk to various groups in the community like the Austin City Council, Travis County Commissioners Court and various other civic organizations to get community endorsements and consent.

"There are number of ways that you can alert us that I'd really rather not be a part of this study," said Ziebell.

Those in Travis County can opt out by calling the UMC Brackenridge Emergency Department, at (512)610-0370 or email protect@researchhpcr.com.