Emergency physicians to test new treatment for traumatic brain injuries
The statistics are grim. Every 15 seconds, someone in the United States suffers a major traumatic brain injury. Every five minutes, someone is forever disabled as a result of a TBI. Some 52,000 deaths per year are caused by these injuries. TBIs are the leading cause of death in people aged 1 to 44.
As a physician in the Emergency Department of Stanford Hospital & Clinics, James Quinn, MD, has treated some of the broken bodies that comprise those numbers. Quinn and his team want to help improve the outcomes for future TBI victims, who often sustain their injuries in car accidents or beatings.
The Stanford team and physicians at 16 other U.S. sites want to test the efficacy of a new drug treatment. In a phase-3 clinical trial that has been approved by the U.S. Food and Drug Administration, patients with traumatic brain injuries would receive progesterone, a hormone normally found in our bodies, to determine if it helps lessen brain swelling and damage.
Animal studies and two small clinical studies have indicated that progesterone may be beneficial in treating TBI patients. Quinn, who is an associate professor of emergency medicine at the Stanford University School of Medicine, also noted that progesterone “has been around a long time, and it’s a substance we know a lot about” because it has been used for birth control and for hormone therapy.
In the trial, TBI patients who are brought to Stanford, Santa Clara Valley Medical Center and the other participating medical centers would be separated randomly into two groups. One group would get an IV mixture that has progesterone, and the other group would get an IV drip without progesterone. Everyone enrolled in the study would receive standard medical care for a brain injury — maintaining blood pressure and providing oxygen — and all patients would be contacted by telephone every month for five months, to check on their progress before returning at six months for final neurological testing.
The proposed trial is unusual because the IV treatment would have to begin within four hours of the onset of an injury — at a time when most TBI patients aren’t alert enough to give consent, and their families can’t get to the emergency department fast enough to give consent. “The people we see in the ED often come in unconscious, and we know from experience that finding family members to give consent for treatment in the emergency setting can be difficult,” Quinn said.
Thanks to federal rules detailing exceptions from informed consent, however, physicians can enroll patients in such studies without getting permission. That’s one of the messages Quinn is spotlighting as he talks about the upcoming clinical trial with focus groups of people who’ve experienced a TBI. “We asked them, ‘Would you have wanted to be in this trial? How would you have felt if someone had put you in this trial without your consent?’”
The response? Quinn said patients overwhelmingly indicated they would have opted to participate in a study of progesterone.
In addition to meeting with focus groups, Quinn and organizers of the clinical trial have published ads in newspapers in recent weeks that explain the benefits and risks of the progesterone trial, known as ProTECT III, to educate local communities about the initiative. It is scheduled to start in late spring and would run for four years, enrolling 1,100 patients nationwide — about eight per year at Stanford.
Area residents who wish to opt out of possibly being included in the clinical trial can do so by calling Stephanie Casal, RN, CSN, at (650) 721-2645. They will be given a bracelet they can wear to alert emergency medical personnel that they have declined to participate in the trial.
“There are people who will never agree with this policy, who don’t think any research should ever be done without consent,” Quinn said. “I, too, believe a person’s autonomy and consent is a vital part of research, but this research is unique because it often is impossible to get consent, and if we didn’t have this federal law to allow this type of research, we would never have been able to develop treatments for emergency conditions.”
Quinn’s collaborators for the trial at Stanford and Santa Clara Valley Medical Center include trauma surgeons David Spain, MD,and John Sherck, MD; neurosurgeons Roland Torres, MD, and Odette Harris, MD; and neurointensivist Christine Wijman, MD.
The ProTECT study is being funded by the National Institutes of Health.
Stanford Medicine integrates research, medical education and health care at its three institutions - Stanford University School of Medicine, Stanford Health Care (formerly Stanford Hospital & Clinics), and Lucile Packard Children's Hospital Stanford. For more information, please visit the Office of Communication & Public Affairs site at http://mednews.stanford.edu.