Researchers are investigating whether monitoring brain tissue oxygen levels in patients with severe traumatic brain injury (TBI) results in higher rates of survival and functionality. The trial at The University of Texas Health Science Center at Houston (UTHealth) is part of a nationwide study that is funded by the National Institutes of Health.
TBI is sudden damage to the brain caused by an outside force to the head – such as a car crash, fall, or blow to the head. An estimated 2.5 million Americans sustain a TBI each year, according to the Centers for Disease Control and Prevention.
The BOOST-3 trial, Brain Oxygen Optimization in Severe TBI, is a Phase III comparative effectiveness trial designed to assess the safety and efficacy of measuring both intracranial pressure (ICP) and brain tissue oxygen (PbtO2), as compared to ICP monitoring alone. Currently, to measure pressure, an ICP monitor is inserted into the brain through a hole in the skull. To measure oxygen levels, an additional device, a PbtO2 monitor, is inserted into the brain through a second hole.
“It is standard practice to monitor ICP to prevent complications from swelling that can be deadly, such as bleeding and herniation,” said Elizabeth Jones, MD, associate professor in the Department of Emergency Medicine at McGovern Medical School at UTHealth and the head of three trial sites in Texas. “However, if the brain is not getting enough oxygen, that can also be fatal and cause other complications due to further loss of brain cells.”
Only about 25 percent of severe TBI patients make a good recovery, and many are left with lifelong disabilities and medical needs, Jones said.
Many hospitals are equipped with Food and Drug Administration-approved PbtO2 monitors to measure oxygen levels, but not all doctors choose to use them.
“Some of the neurosurgeons who work with the oxygen monitors really believe in them. Others don’t use them because there is limited data on whether incorporating their data into treatment strategies can actually improve mortality and quality of life,” Jones said.
A preliminary version of the BOOST trial found that monitoring both ICP and PbtO2 reduced brain tissue oxygen deficiency with a trend toward more favorable outcomes than ICP monitoring alone.
“If measuring oxygen levels is going to positively affect a patient’s outcome, we certainly want to make sure that’s being done in intensive care units across the country,” Jones said. “However, we also want to be sure that using the PbtO2 monitor is going to help the patient before we routinely use the device. The monitors are expensive, so we hope this study can provide more insight on their effectiveness so we can make informed decisions on their use moving forward.”
BOOST-3 will begin in the spring of 2019 at 45 clinical sites across the country and will continue for five years. The sites in South Texas include Memorial Hermann – Texas Medical Center, Harris Health Ben Taub Hospital, and UT Health San Antonio. All enrolled patients will have PbtO2 monitors and ICP monitors placed within six hours of arrival at the hospital, and will then be randomized to treatment based on ICP alone or treatment based on both ICP and PbtO2 in the first five days after injury.
Because unconsciousness is a requirement to enroll in the study, informed consent is not feasible. Researchers will contact family members and legally authorized representatives to obtain permission, and if neither can be located, the patient will be enrolled. For those enrolled without consent, consent will be sought from family members at the earliest opportunity.
In order to inform the community of the proposed study, Jones and other members of the research team presented the study and answered questions at a series of meetings with groups in and around Houston. Researchers are also running a social media campaign to inform the public.
If you do not wish to participate in this proposed research study, please email firstname.lastname@example.org to obtain an “opt-out” bracelet that must be worn for the five-year duration of the study.
For more information about this research study, please visit https://www.uth.edu/ctrc/participants/efic/boost-3.
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