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ProTECT III study targets treatment for traumatic brain injury

  • Published
  • By Sue Campbell
  • 59th Medical Wing Public Affairs
FORT SAM HOUSTON, Texas --  Air Force doctors at Brooke Army Medical Center will soon begin a research study to see if progesterone can decrease damage from a traumatic brain injury (TBI).

Traumatic brain injury is sudden damage to the brain caused by an outside force such as a car crash, a fall, or something hitting the head. Every 15 seconds someone in the U.S. suffers a major TBI and every 5 minutes someone is forever disabled as a result of a TBI.

TBI is expensive to families and the society. The lifetime cost to care for a survivor of a severe TBI can be greater than $4 million and the total yearly cost of TBI in the U.S. was almost $60 billion in 2000.

"Even though it is a huge problem, scientists have not been able to come up with a drug treatment that works for TBI," said Air Force Colonel (Dr.) Randall McCafferty, Chief of Neurosurgery at BAMC and lead researcher on the TBI study there. "In fact, no medication has been helpful in treating TBI in over 30 years."

Since there is no specific drug treatment for TBI, currently physicians try to control blood pressure and oxygen levels to limit the amount of damage to the brain. However, recent studies have shown that progesterone may be effective to decrease brain damage from a TBI.

"Small studies in humans have shown that progesterone is safe and might decrease brain injury. A large study is now ongoing to find out whether it is helpful in treating TBI," said Dr. McCafferty. "There are 17 medical centers across the U.S. that are already participating in the study and BAMC was recently chosen as an additional research participant."

"Considering the number of military members who suffer TBI on the battlefield, it's exciting to be part of this research," he said.

Progesterone is a hormone found in the human body and is a Food and Drug Administration-approved medication that has been used for decades, but not for treatment of TBI. Many animal studies show that giving progesterone soon after a TBI may reduce brain swelling and damage.

"There are possible side effects as progesterone can increase liver enzymes and the risk of blood clots and infection, but since we do not have a treatment that is best for TBI, a person entered into this study has a chance to benefit significantly by participating," said Dr. McCafferty.

The ProTECT III study will involve individuals who have suffered a TBI and are brought to the BAMC emergency department for care. If an individual meets the research criteria, they will be included in the study unless they have indicated they do not wish to participate in advance.

"Normally people have ample time to decide whether they want to participate in a research study, but individuals who have just suffered a TBI are not alert enough to understand the study or to consent," said Dr. McCafferty. "The study medicine has to be given quickly, so there may not be enough time to reach their legal guardian who can give permission."

Therefore, this study will fall under very specific federal rules called Exception from Informed Consent, or EFIC.

EFIC guidelines require the BAMC emergency department to attempt to locate a legally authorized representative, or LAR, for one hour to get permission to enter a patient into the study. If a LAR cannot be located in that time, the patient will be started on the study medicine without consent, but the treatment can be stopped if a LAR is located and objects to the study.

If a person does not want to be in the study they will be able to log on to the ProTECT III website at www.protectiii.com to sign up for the opt-out registry.

EFIC rules also require the researchers to inform the community about the study. Dr. McCafferty and members of his team will be scheduling town hall meetings with various organizations in the San Antonio area to explain the study and assess public opinion.

"The study has not been officially approved or started here yet and we are eager to hear comments from anyone in the San Antonio area who has a concern or wishes to voice their support," said Dr. McCafferty. "We are excited to proceed and be part of something that may benefit future TBI patients at home and at war."

For more information about ProTECT III, contact the study team at 916-1827 or access the research web site at www.protectiii.com.