A new blood test will help doctors determine if someone has a traumatic brain injury after suffering a blow to the head.
Until now, physicians have had to rely on subjective markers—mainly patient-reported symptoms such as headaches, nausea, or light sensitivity—to make an educated “guess” on the possibility of brain trauma and the need for a head CT scan.
Particularly among athletes who may hide symptoms in order to keep playing, a subjective assessment isn’t always reliable, researchers say. The new test provides an objective indicator of injury that can potentially be obtained quickly and easily in busy emergency departments.
In February 2018, the US Food and Drug Administration approved the test as part of a fast track program to get breakthrough technologies to patients more quickly. Called the Banyan Brain Trauma Indicator, the test helps evaluate patients with a suspected traumatic brain injury, or concussion, also known as a mild traumatic brain injury.
As reported in The Lancet Neurology, the clinical trial that led to approval of the test, included close to 2,000 people presenting with a head injury to 22 emergency departments in the US and Europe.
“Many concussion patients don’t seek medical care for their injury, a decision due in part to the perception that emergency departments have nothing to offer in terms of diagnosis, says lead author Jeffrey J. Bazarian, professor of emergency medicine at the University of Rochester Medical Center.
“The results of this study show that we now have something to offer—a brain biomarker blood test. The ability of this test to predict traumatic injuries on head CT scan will soon allow emergency physicians to provide patients with an unbiased report on the status of their brain.”
Fewer CT scans
Bazarian, who’s conducted research on concussions and traumatic brain injury for more than 20 years, says he believes the tool will be valuable for emergency room physicians and reassuring for concerned patients and families.
The test detects two brain proteins that are present in the blood soon after a hit to the head. The study shows that if the test is negative—meaning the brain proteins aren’t present—it’s highly unlikely that a traumatic intracranial injury exists and that a head CT scan can be safely avoided.
If the test is positive, a brain injury may be present and the patient should receive a head CT scan to further assess the damage and guide treatment.
Approved for use in people 18 years and older, the test has the potential to reduce CT scans and the radiation exposure that comes with them. CT scans are a common way to evaluate brain injuries, but research shows that less than 10 percent of them show any injury.
Limiting scans to patients with a positive blood test could eliminate needless radiation; allow people to get in and out of the emergency room faster; and lower health care costs.
The blood test is effective up to 12 hours following injury and picks up the presence of the brain proteins UCH-L1 and GFAP. Bazarian says these are useful markers because they aren’t elevated when someone gets hit outside the head, such as the shoulder or abdomen.
The US Centers for Disease Control and Prevention estimates that traumatic brain injury results in more than 2.5 million emergency department visits annually in the US. Falls, sports-related injuries, car accidents, assaults, and combat wounds for members of the military are common causes of brain injury.
Testing of the Banyan Brain Trauma Indicator took place in the UR Medicine Strong Memorial Hospital emergency department on approximately 200 people who presented with a head injury.
Additional coauthors are from the Technical University of Munich, Mount Sinai Health System, and Wayne State University School of Medicine.
Funding for the study was provided by Banyan Biomarkers, Inc. and the US Army Medical Research and Materiel Command. Bazarian received research support from Banyan Biomakers, Inc. to cover all activities related to the study. Banyan Biomarkers, Inc. is working with its commercial partners to make the test available in hospitals and emergency departments.
Source: University of Rochester