New traumatic brain injury test is “game-changing,” experts say
The Centers for Disease Control and Prevention (CDC) estimates that there are approximately 2.5 million traumatic brain injury (TBI)-related emergency department (ED) visits annually. Recent media coverage has focused on the occurrence of TBI in professional sports, but the reality is that the impact of TBI-related morbidity extends beyond high-level athletics. Almost 1 million ED visits for TBI occur annually in pediatric populations, and accidents (including falls and motor vehicle collisions) are the primary cause of TBI-related medical encounters.
Victims of TBI may suffer a broad range of symptoms, including headaches, confusion, vision changes, memory difficulties and unexplained fatigue. Additionally, subtle changes in concentration and sleep patterns may be the only manifestation of TBI. This wide spectrum of nonspecific presentations has made the diagnosis and management of TBI quite challenging for providers. Down the line, this results in an overuse of expensive imaging tests in some patients, while others receive delayed treatment due to late recognition of the disease process. In the worst cases, some TBI patients never get diagnosed, ultimately suffering gradual declines in quality of life and productivity.
Fortunately, help is on the horizon for health care practitioners taking care of TBI patients. In January 2021, the Food and Drug Administration (FDA) granted 510(k) clearance to the first rapid handheld TBI blood test, which will help clinicians assess patients with suspected mild TBI, including concussion.
A prospective study led by UCSF, published in the Lancet Neurology, explored the correlation between blood levels of glial fibrillary acidic protein (GFAP) and visibility of intracranial injury on computed tomography (CT) and MRI imaging. The study included 450 patients at 18 level I trauma centers across the United States over the course of four years. Study results demonstrated a significant association between elevated blood concentrations of GFAP and TBI findings that are detectable on MRI but not on CT scan. When applied in clinical practice, this test will help clinicians decide which patients would benefit from advanced imaging to diagnose TBI.
Given the burden of disease from TBI, the potential impact of study findings and subsequent FDA clearance is quite significant. John Yue, MD, the first author on the study and a resident in the Department of Neurological Surgery at UC San Francisco (UCSF), says, “The blood test may help clinicians decide who can safely avoid a CT scan, with the advantage of not exposing patients to radiation from CT.”
He goes on to highlight how the test may help providers distinguish among etiologies of common symptoms, noting, “Patients with concussion may present as confused and disoriented, and may repeat themselves – symptoms that are similar in people with intoxication. With the blood test, we can discern whether their symptoms are primarily due to brain injury and treat accordingly.”
The impact of these findings is further emphasized by Geoffrey Manley, MD, PhD, professor and vice chair of the Department of Neurological Surgery at UCSF and senior author on the study. He notes, “These blood-based biomarkers are the next step in the evolution of diagnosing and treating TBI.… We are finding that not only are they more sensitive than CT in identifying TBI, but they may be more accurate than the current standard of MRI.” Dr. Manley is also the principal investigator in the Traumatic Brain Injury Network (TRACK-TBI) program, a federally funded clinical trials effort designed to improve the diagnosis and management of TBI nationally. He adds, “A blood test that can rule out the need for a CT scan has huge implications from both a time and cost perspective for patients. The sooner we can diagnose TBI, the sooner we can begin treatment, which is paramount in helping patients return to their normal lives.”
The GFAP test, along with the complementary ubiquitin carboxyl-terminal hydrolase L1 lab test, can be obtained rapidly on the Abbott i-STAT Alinity platform, which has received FDA clearance for use in potential TBI patients. Generating results as quickly as 15 minutes after blood is drawn, these tests stand to significantly improve the efficiency of care provided to TBI patients.
Department of Neurological Surgery at UCSF
The Department of Neurological Surgery at UCSF is home to leading physicians and scientists dedicated to treating patients with neurosurgical disorders and to the search for better therapies and cures. Our mission is to provide the best clinical care to our patients, investigate the most promising advances in neuroscience research, and train tomorrow's leaders in neurosurgery. Patient referrals to the various divisions within the department can be made here.
UC San Francisco (UCSF) is a leading university dedicated to promoting health worldwide through advanced biomedical research, graduate-level education in the life sciences and health professions, and excellence in patient care. It includes top-ranked graduate schools of dentistry, medicine, nursing and pharmacy; a graduate division with nationally renowned programs in basic, biomedical, translational and population sciences; and a preeminent biomedical research enterprise.
UCSF Health includes three top-ranked hospitals – UCSF Medical Center and UCSF Benioff Children’s Hospitals in San Francisco and Oakland – as well as Langley Porter Psychiatric Hospital and Clinics, UCSF Benioff Children’s Physicians and the UCSF Faculty Practice. UCSF Health has affiliations with hospitals and health organizations throughout the Bay Area. UCSF faculty also provide all physician care at the public Zuckerberg San Francisco General Hospital and Trauma Center, and at the San Francisco VA Medical Center. The UCSF Fresno Medical Education Program is a major branch of the UCSF School of Medicine.