Biomarkers in the Brain Oxygen Optimization in Severe TBI Trial (Bio-BOOST)
Abstract
Traumatic brain injury (TBI) remains a major cause of death and disability, with an estimated cost of $45 billion per year in the United States alone. Patients with severe TBI, defined as those who are unconscious or only minimally responsive to external stimulation, have an especially poor prognosis. Approximately 35% of patients with severe TBI die within 6 months of injury, and among those who survive, approximately 80% have lifelong disabilities, representing a large unmet medical need. One of the critical barriers to progress in discovering new treatments for severe TBI is the lack of blood tests that can guide the personalization of TBI treatments so that the right treatment is administered to the right type of TBI patient. Additionally, there are no blood tests for monitoring ongoing brain injury and individual patient response to treatment. The recently funded BOOST-3 (Brain Oxygen Optimization in Severe TBI Phase 3) trial offers a unique opportunity to study and validate new blood tests for TBI. BOOST-3 will enroll 1094 participants with severe TBI from 2018 to 2023, across 45 clinical sites in the United States, and represents a $32.5 million federal investment. BOOST-3 will examine whether severe TBI treatment based on brain tissue oxygen and intracranial pressure values obtained from probes inserted into the brain will improve neurologic outcome at 6 months after injury, compared to treatment based on intracranial pressure monitoring only. Capitalizing on the infrastructure and the rich study population for BOOST-3, we propose conducting an ancillary biomarker study, Bio-BOOST. The main goal of Bio-BOOST is to determine how the lack of oxygen to brain tissues affects the levels of blood tests for brain injury. Bio-BOOST will enroll 300 patients already enrolled in the BOOST-3 study. We will collect blood samples, cerebrospinal fluid samples, DNA and RNA samples from eligible subjects from the day of enrollment up to 6 months after injury. This study will provide the scientific evidence that is needed to proceed with using blood tests to monitor ongoing brain injury and individual patient response to TBI treatment. Military Service members are at particular risk for severe TBI, arising from combat injuries, but also as a consequence of training accidents and living in harsh environments.
Document Details
- Document Type
- DoD Grant Award
- Publication Date
- Nov 19, 2019
- Source ID
- W81XWH1910829
Entities
People
- Ramon Diaz-Arrastia
Organizations
- United States Army
- University of Pennsylvania