Oregon Health & Science University is among 46 trauma centers across the country to participate in a new clinical trial that aims to improve outcomes for people with severe traumatic brain injuries.
Traumatic brain injuries involve sudden damage to the brain, for example during a motor vehicle crash or falling from a tree or building. Traumatic brain injuries affect an estimated 3.5 million Americans annually, with 300,000 who end up in the hospital.
The clinical trial will compare two strategies for monitoring and treating patients with brain injuries in intensive care units.
The five-year study will enroll OHSU patients beginning in January. The study is known as Brain Oxygen Optimization in Severe TBI Phase 3, or BOOST 3.
Notably, because these patients are typically not in a position to provide written consent, the study is being conducted under an exception from informed consent allowed by the U.S. Food and Drug Administration.
The FDA allows certain studies to be done without written consent in emergency settings, provided the patient has a high risk of dying without treatment, cannot talk because of their illness, does not have family available to speak for them, and community members have the ability to opt out ahead of time. In addition, researchers have consulted about the study with community members and at-risk groups. If enrolled, researchers will inform the patient’s legally authorized representatives as soon as feasible so that they can determine if the patient should continue in the study.
BOOST 3 will compare clinical outcomes among patients grouped into two treatment protocols:
- Treatment goals based on monitoring of intracranial pressure alone.
- Treatment goals based on monitoring both intracranial pressure and oxygen in brain tissue.
“We’re evaluating whether this additional information improves the patient’s outcome six months after injury,” said principal investigator David Zonies, M.D., M.P.H., professor of surgery (trauma, critical care and acute care surgery) in the OHSU School of Medicine.
In each strategy, the treatment protocol helps clinicians adjust treatments in the intensive care unit. That could include adjustments to ventilator settings, medications to reduce brain swelling, variations in the amount of intravenous fluids given, and considering whether to do a blood transfusion.
Both protocols are considered acceptable, but the new study will determine whether one or the other should become the preferred standard of care across the medical profession.
The nationwide study will enroll a total of 1,094 patients over the next five years.
Each participant will be followed six months after the initial injury to determine their objective measure of recovery through use of an assessment tool known as the Glasgow Outcome Scale. Patients are measured on a 1 to 8 scale on measures such as motor function, cognition and wakefulness.
Participants will be enrolled within six to 12 hours of their initial injury.
Holly Hinson, M.D., M.C.R., an associate professor of neurology in the OHSU School of Medicine and a neurointensivist who specializes in caring for patients with brain injuries, said clinicians will verify the patient wants to continue in the study as soon as a family member or other legally authorized representative is located at the hospital. Then, following discharge, the patient’s recovery will be assessed over the next six months.
OHSU handles about 50 severe traumatic brain injuries each year requiring this invasive monitoring, Zonies said, which may make it one of the higher-enrolling centers in the new study.
“Our hope is that this helps us guide decision-making about treatments, including when to escalate to decide whether somebody needs surgery or not,” said Seunggu Jude Han, M.D., assistant professor of neurological surgery in the OHSU School of Medicine.
The study is run through SIREN, or Strategies to Innovate Emergency Care Clinical Trials Network. In 2017, the National Institutes of Health designated OHSU as one of 11 nationwide hubs for the network. The large scale and wide geographic distribution allows doctors to draw conclusions about uncertain medical interventions that are currently assumed to be of equal benefit.
If you want to opt out of the study, contact 503-494-4315 or firstname.lastname@example.org