Traumatic brain injury (TBI) is the leading cause of death and disability in children and adults up to 44 years of age. Every 15 seconds someone in the US suffers a major traumatic brain injury, and every five minutes someone is forever disabled from traumatic brain injury.
Temple University Hospital is participating in a National Institutes of Health-funded, clinical research study that seeks to improve outcomes after TBI. The Brain Oxygen Optimization in Severe TBI, or BOOST-3 trial is a nationwide, phase-3 clinical trial being led by the University of Michigan that aims to learn if either of two strategies for monitoring and treating patients with severe TBI in the intensive care unit (ICU) is more likely to help them get better. Both of these alternative strategies are used in standard care. It is unknown if one is more effective than the other.
“In one strategy, doctors concentrate on preventing high intracranial pressure caused by a swollen brain. In the other strategy, doctors try to prevent high intracranial pressure and also try to prevent low brain oxygen levels,” said Michael Weaver, MD, Chair and Professor in the Department of Neurosurgery at the Lewis Katz School of Medicine at Temple University, and Temple’s primary investigator for the study. “The results of this study will help doctors discover if one of these methods is more safe and effective.”
The study will include adults and children older than 14 years with severe brain injury requiring admission to the ICU with brain monitoring. Patients who meet the entry criteria will be randomly assigned to one of the two study groups.
Because head injury is a life threatening condition requiring immediate treatment, some patients will be enrolled without consent if a family member or other representative is not rapidly available. Every attempt will be made to locate family prior to enrollment to allow them to decide about the patient’s participation in the study. Before the study starts, meetings will be held in the community to provide information, answer questions and get community members’ thoughts and feelings about the study.
For more information or to decline participation in the study, the public can visit boost3trial.org, or contact Temple’s study staff at 215-707-5483.
The BOOST-3 study is part of The Strategies to Innovate Emergency Care Clinical Trials Network (SIREN). SIREN is funded by the National Institutes of Health. The network 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 SIREN Network funds 13 institutions across the country, including Temple, to coordinate and enroll subjects at many additional hospitals. About 45 hospitals will participate in BOOST-3. Four of those hospitals are in the Philadelphia-area, including Temple, Cooper University Hospital, Penn Presbyterian Medical Center and Thomas Jefferson University Hospital.