TUCSON, Ariz. – A new clinical trial affecting the treatment of Southern Arizona patients with traumatic head injuries is under way in the University Medical Center Trauma Center.
UMC is one of 17 major trauma centers around the country participating in the ProTECT III study (www.protectIII.com), a five-year, $14.5 million research project funded by the National Institutes of Health.
The Progesterone for the Treatment of Traumatic Brain Injury (ProTECT III) study will determine if the hormone progesterone is useful in improving outcomes following severe head injury, as suggested in small preliminary studies by Atlanta’s Emory University, which is leading the nationwide clinical trial.
In Tucson, the study is being coordinated through the Arizona Emergency Medicine Research Center, a center of excellence within the University of Arizona College of Medicine. Kurt Denninghoff, MD, professor in the UA Department of Emergency Medicine and a member of the BIO5 Institute at the UA, and Randall S. Friese, MD, associate professor in the UA Department of Surgery, are the principal investigators.
Traumatic Brain Injury (TBI) is sudden damage to the brain caused by an outside force to the head, such as a car crash, a fall or any blow to the skull. The UMC Trauma Center, the only Level 1 Trauma Center in Southern Arizona, treats approximately 500 patients with moderate to severe TBI each year, said Dr. Friese, a trauma surgeon.
For those who survive, TBI can affect a person’s ability to concentrate and remember as well as cause problems with balance and coordination, he said. Many survivors of traumatic brain injury are severely disabled. TBI is the leading cause of death and disability in children and adults 1 to 44 years of age in the United States, causing some 50,000 deaths and 80,000 new cases of long-term disability each year.
Preliminary studies in the United States and China have shown that progesterone, when given immediately after TBI, may reduce brain swelling and damage. One study showed a 50 percent decrease in mortality. Progesterone is naturally present in small amounts in the brains of both males and females. Progesterone is critical for the normal development of neurons in the brain and seems to have a protective effect on damaged brain tissues.
As part of the ProTECT III clinical trial, brain-injured adults treated in the UMC Trauma Center may receive progesterone if they are 18 or older, have a moderate to severe brain injury and can start the medication within four hours of the injury. Patients who meet these and other criteria will be entered randomly – like flipping a coin – into one of two study groups: one that receives an IV mixture with progesterone and one that receives an IV mixture with placebo.
Everyone in the study will be given the standard medical care for brain injury. This is a double-blind study, meaning that neither the patient nor doctors, nurses or researchers will know if any particular patient received the progesterone or placebo.
Normally, researchers get permission or consent before a person participates in a clinical study. But a person with a severe head injury is not able to give consent at the time of treatment, because he or she is unconscious. Since TBI must be treated quickly, there might not be enough time to locate and talk to the person’s family or legal guardian about the study, so it’s possible that a person might be enrolled in the study without consent. Once the family or legal guardian is located, they will be asked for permission for the patient to continue in the study.
The U.S. Food and Drug Administration permits research studies in certain emergency situations to be conducted without consent, but requires researchers to provide information about the study to the community and get their feedback. The Arizona Emergency Medicine Research Center has been running ads in local media since January explaining the study, inviting public comment and offering Southern Arizonans an opportunity to opt out of the study if they wish.
To date, no one has called requesting the opt-out bracelet showing they do not wish to participate, said Ginny Rizzo, RN, study research coordinator.
“This is an exciting trial, and if the study actually demonstrates improvement in those treated with progesterone, it would be a medical landmark in emergency medicine,” Dr. Denninghoff said.
“None of us believes we’ll ever be a victim of head injury, but the reality is that lots of people are getting head injuries all the time, and the human costs are just tremendous,” he said.