Tri-State Study Offers TBI Patients Promising Treatment
MEMPHIS— At a medical meeting last year, Jay E. Mattingly, MD, an anesthesiologist at the University of Tennessee Health Science Center (UTHSC), was intrigued when an Emory professor shared information about a unique study offering promising treatment for victims of traumatic brain injury (TBI). Knowing the Memphis area represents a substantial TBI population, Mattingly made a connection with the speaker and shared the conversation with Martin A. Croce, MD, upon his return to Memphis.
Croce, professor of surgery and chief of the trauma and critical care division at UTHSC, and medical director of the Presley Regional Trauma Center, was enthusiastic about the news. Concurrently, he had been perusing information about earlier National Institutes of Health-funded ProTECT studies.
“A new national study, ProTECT III, was getting underway and didn’t include a participant in our region, so we contacted Emory and got ourselves involved,” said Croce, pointing out that TBI is the leading cause of death and disability in children and adults ages 1 to 44.
The ProTECT III study, which began in the first quarter of 2011, involves the UTHSC and adults with TBI who enter the Elvis Presley Memorial Trauma Center at the Regional Medical Center (The MED), the only Level 1 Trauma Center serving patients in the Mid-South within a 150-mile radius of Memphis.
Because no specific drug treatment is given for new TBI patients, the research study is designed to see if progesterone, given within four hours of a TBI, works better than standard medical care alone in reducing brain damage caused from a TBI.
“Physicians in the region have been excellent about transferring appropriately injured patients to the trauma center,” said Croce. “We’re looking at patients that have moderate to severe brain injury to see if we can help them with this study. Those patients, for the most part, all get transferred to us anyway so if physicians can just keep doing what they’re doing, and not give those patients any steroids or the like before transferring them, they can be involved in the study.”
Of the two study groups in which TBI patients will randomly be entered, one study group will receive a fluid mixture that contains progesterone infused into a vein while the other group will receive a placebo fluid mixture. All study participants will also receive standard medical treatment for brain injury. Possible risks of receiving the study drug progesterone include increased risk of blood clots in the body, increased liver enzymes, possible increased risk for infections, and pain or bruising at the site where the drug is administered. The IV fluid mixture used in the study contains an egg product that may cause an allergic reaction in people with egg allergies.
“Two things stand out about this study,” said Croce. “Quite frankly, the standard of care, although it’s what we all do in trying to take care of TBI patients, isn’t very good. A substantial number of TBI patients don’t have a very good functional recovery from their TBI. Ideally, our goal would be to get these patients over their brain injury and back into roles where they can continue to contribute to society. Unfortunately, a good number of those patients are unable to do that and become consumers of societal resources to the tune of about $60 billion a year in the United States. It’s a serious problem.”
Secondly, in pre-clinical trials, the use of progesterone, when given early, has shown to be very beneficial, said Croce.
“Nothing’s 100 percent, but it’s shown to increase functional survival following TBI,” he said. “Clearly, this needs to be tested more rigorously before it’s used in a widespread fashion, and that’s the purpose of this particular trial.”
An obstacle that study administrators face in the ProTECT III trial is gaining consent before a TBI patient may be included in the study because that patient may not be able to give permission at the time of the injury. Since TBI must be treated quickly, and emergency personnel may lack sufficient time to locate and speak with the person’s legal guardian about the study, the patient may be enrolled in the study without consent via “Exception from Informed Consent” (EFIC). The legal guardian, when located, will be provided study information and will be asked to either give permission allowing the injured person to continue in the study or to end study participation.
There are two methods that patients may opt-out of the TBI study in advance. They may add their names to a national online registry, a list that’s checked prior to a TBI patient being considered for enrollment into the study if identification is available, or they may contact UTHSC to request an “opt-out” bracelet labeled “ProTECT III declined.”
“It’s important for physicians to have the public understand they may be enrolled in the study prior to consent,” said Croce. “That doesn’t mean that we’ll just willy-nilly put people in the study without informing them. Because of the nature of this study, we’re very aggressive in identifying the next of kin to the patient. Then we explain the study to them and get their consent to continue. This is the fourth or fifth study that we’ve done with the waiver-of-consent issue, and I can count on one hand—and have fingers left over—of the number of people who’ve opted out of a study. In general, people understand that we have to act quickly, and this is one way that will allow us to get a little bit smarter and be able to take better care of TBI patients. That’s really what it’s all about.”
For more information about the ProTECT III study, visit www.protectiii.com, call (901) 448-4488, or email firstname.lastname@example.org.