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 something hitting the head. An estimated 2.5 million Americans sustain TBI each year, according to the Centers for Disease Control and Prevention. Severe TBI contributes to 30% of all injury-related deaths, and many who survive are left permanently disabled.
Cooper University Health Care is participating in a clinical trial— the Brain Oxygen Optimization in Severe TBI, Phase 3 (BOOST-3)— with a goal of improving outcomes of those victims of severe TBI. As a leading trauma center and among the busiest in the United States, Cooper was accepted into this National Institutes of Health-sponsored study as a participating site because of its experience in treating severe traumatic brain-injured patients. Other prestigious universities participating in the study include Baylor, Columbia, Duke, Emory, Stanford, and Georgetown, along with the Universities of Washington, Massachusetts, Texas, Maryland, Pittsburgh, and Pennsylvania among others.
“Of the nearly 300,000 hospital admissions in the United States annually for TBI, about 40% are classified as severe,” said Rachel L. Sensenig, MD, a trauma surgeon at Cooper and co-principal investigator for the study at Cooper. “As a leading academic tertiary hospital and South Jersey’s only Level 1 Trauma Center and Level 2 Pediatric Trauma Center, we see a large number of these types of head injuries on regular basis.”
“Unfortunately, less than 20% of patients with a severe TBI make a good recovery—and many are left with lifelong disabilities and medical needs,” added Tapan R. Kavi, MD, a neuro intensive care specialist at Cooper and co-principal investigator. “TBI can affect a person’s ability to think and remember things, cause problems with balance and coordination, prevent a person from functioning independently, or cause permanent brain damage or even death.
The BOOST-3 study is a randomized clinical trial to determine the comparative effectiveness of two strategies for monitoring and treating patients with traumatic brain injury (TBI) in the intensive care unit (ICU). One involves interventions to prevent high ICP (intracranial pressure) caused by a swollen brain. In the other strategy, doctors try to prevent high ICP and also try to prevent low oxygen levels to the brain. Both of these strategies are currently used in standard care, but it is unknown if measuring and treating low brain oxygen is more effective, less effective, or the same as monitoring and treating high brain pressure alone.
The BOOST-3 study is part of the Strategies to Innovate Emergency Care Clinical Trails Network (SIREN). SIREN is funded by the National Institutes of Health and seeks to improve the outcomes of patients with neurologic, cardiac, respiratory, hematologic, and trauma emergencies by identifying effective treatments administered in the earliest stages of critical care.
The five-year BOOST-3 trial has a goal of enrolling 1,094 participants with severe TBI across 45 National Institutes of Health-funded sites which includes Cooper. Cooper hopes to enroll 25 patients in the study. All subjects will be randomized within six hours upon arriving at a participating hospital and no more than 12 hours from injury-diagnosis. They will be followed for six months to measure functional outcomes and neurological function.
Because head injury is a life threatening condition requiring immediate treatment, some patients will be enrolled without consent if a family member or representative is not rapidly available.
Boost3trial.org contains more information about the study, including details about how community members can decline participation.
Wendy A. Marano
Public Relations Manager