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A study at the University of Tennessee Health Science Center may be the first step toward reclaiming a functional, lengthy life for patients suffering from traumatic brain injuries.

Known as ProTECT III, the study focuses on the hormone progesterone, a naturally occurring neural protectant in humans that has been shown in pre-clinical trials to reduce brain swelling and damage if administered immediately following an injury.

No medication for effective treatment of such trauma is currently approved by the Food and Drug Administration.

Dr. Martin Croce, local leader of the national study, is a UTHSC professor of surgery and chief of the school’s College of Medicine Division of Trauma and Critical Care. He says preliminary results from ProTECT III appear to show a “promising” departure from the traditional treatments of traumatic brain injuries.

“What we do now is basically try to support patients until they get better or they don’t,” Croce says of standard brain trauma treatment. “If they have something that… (needs) to be operated on, that’s one thing. But most patients don’t, and (in those cases) we try to maximize their supportive care as best we can.”

Work on the ProTECT III comes as UTHSC marks its 100-year history, a period over which the institution’s medical research has become a “guidepost not only for (UTHSC), but for everyone else in the state of Tennessee,” says Richard Nollan, director of the Health Sciences Library and leader of the UTHSC Centennial Committee. To celebrate, the center will host a gala for students and faculty in September, establish a website commemorating its centennial and publish a 159-page book on its history.

“We’ve been here as the state’s only health care program for 100 years,” Nollan says. “The investment by the state of Tennessee into the work that we do has more than bore fruit over that period of time.”

As the centennial is marked, efforts such as the ProTECT III study underway on campus underscore how the university’s research efforts can have national implications. Nearly 2 million people suffer traumatic brain injuries annually in America, resulting in almost a quarter-million hospitalizations and approximately 50,000 deaths. About 80,000 become physically disabled following brain trauma, a large portion of whom is no longer able to care for themselves, Croce says.

In ProTECT III pre-clinical trials, patients treated with progesterone saw lower mortality rates and an improved ability to carry out what Croce calls “the activities of daily living.”

Though the likelihood of patients’ returning to their full, pre-injury lives has yet to be determined, Croce said the long-term, incremental benefits of progesterone treatment could be “huge.”

“The progesterone is prolonging life,” Croce says. “It’s a baby step forward for (some) patients. But for all we know, it might be giant step forward for some of the others.”

Risks associated with treating brain trauma with the hormone appear to be “amazingly minimal,” he says. In controlled studies, reactions related to food allergies were the only side effect of treatment. Such reactions are “very easily treated” by simply stopping administration of the study drug, he says.

“In this particular trial, I think it’s pretty safe to say that because of the fact that we’re giving a naturally occurring hormone, there’s really no more than minimal risk for the patients,” Croce says.

As treatment for brain injuries must begin quickly, study administrators established a four-hour window between the time of the injury and the beginning of treatment. With patients suffering from brain trauma unable to give consent for their participation in the study, doctors have begun treating some patients with progesterone under the FDA’s Exception to Informed Consent measure until a spouse, guardian or blood relative of the patient is located.

Jay Mattingley, UTHSC clinical director of anesthesiology, says that, following injury, the “inflammatory surge” of damaging cellular reactions the brain suffers makes immediate treatment vital.

“The sooner you can do that – prevent that brain edema and swelling from occurring – the better,” he says.

With approximately 200 patients currently enrolled, consent for the ProTECT III study has been very high, Croce says.

“I can’t think of one family that has opted out of the study,” he says. “Once we explain it to them, in general, the families are very accepting.”

ProTECT III researchers also have their sights set on enrolling 1,000 patients in the program.

If current trends in the study continue, researchers may reach their mark in the same fashion they administer progesterone to trauma patients – sooner, rather than later.

“It’s exciting that we may have something here in progesterone that may dramatically improve functional outcomes,” Mattingley says.