Blood Test Traumatic Brain Injury Detection Changes Emergency Medicine
For the first time, a blood test traumatic brain injury detection tool is available to help emergency physicians determine whether a blow to the head has caused intracranial bleeding or bruising. The FDA approved the Banyan Brain Trauma Indicator in February 2018 through a fast track program designed to accelerate access to breakthrough technologies. The major clinical trial supporting the approval was subsequently published in The Lancet Neurology. According to the Mayo Clinic, traumatic brain injury affects millions of people annually and ranges from mild concussion to severe, life threatening injury.
Why Subjective Assessment Was No Longer Sufficient
Before the blood test traumatic brain injury tool existed, physicians relied entirely on subjective markers such as patient reported headaches, nausea, and light sensitivity to determine who needed a head CT scan. This approach is unreliable in many real world settings. Athletes in particular may conceal symptoms in order to remain in play, and patients may underreport or misremember the intensity of symptoms in a busy emergency department.
The new test provides an objective, biological indicator of injury that can be obtained quickly and easily, eliminating the guesswork that previously defined this clinical decision.
How the Banyan Brain Trauma Indicator Works
The blood test traumatic brain injury tool detects two brain proteins, UCH-L1 and GFAP, that are released into the bloodstream shortly after a head injury. These proteins are specific to brain trauma and are not elevated when someone sustains a hit to a non-head area of the body such as the shoulder or abdomen, making them reliable and precise indicators.
If the test is negative, meaning the brain proteins are not present at elevated levels, it is highly unlikely that a traumatic intracranial injury exists and 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 CT scan to assess the extent of damage and guide treatment. The test is approved for individuals aged 18 and older and is effective up to 12 hours following the injury.
3 Alarming Findings From the Clinical Trial
1. The Trial Enrolled Nearly 2,000 Patients Across 22 Emergency Departments
The clinical trial supporting FDA approval of the blood test traumatic brain injury tool included close to 2,000 individuals presenting with head injuries to 22 emergency departments. This scale provides a robust evidence base and reflects the diversity of real world emergency presentations across different patient populations and injury types.
2. Fewer Than 10% of Head CT Scans Show Any Injury
Research cited in the study found that less than 10% of CT scans performed for head injuries reveal any detectable damage. This means the vast majority of patients currently receiving radiation exposure and extended emergency department wait times are doing so unnecessarily. By limiting CT scans to patients with a positive blood test traumatic brain injury result, clinicians can eliminate needless radiation, reduce costs, and free up emergency department capacity.
3. Concussion Patients Often Avoid Emergency Care Entirely
As lead author Jeffrey Bazarian, professor of Emergency Medicine at the University of Rochester Medical Center, noted, many concussion patients do not seek care because they believe emergency departments have nothing to offer diagnostically. The blood test traumatic brain injury tool changes that perception by giving emergency physicians an objective biomarker based report on brain status, potentially drawing more patients into care who would otherwise go undiagnosed and untreated.
Why This Matters for Clinical Research and Public Health
The US Centers for Disease Control and Prevention estimates that traumatic brain injury results in more than 2.5 million emergency department visits annually, caused by falls, sports injuries, car accidents, assaults, and combat wounds. A validated blood test traumatic brain injury detection tool has the potential to transform triage protocols, reduce unnecessary imaging, and ensure more patients receive timely and accurate diagnoses.
FOMAT conducts Phase I through Phase IV clinical research across a national network of investigator sites throughout the United States. To learn more about active neurology studies, visit our patient active studies page.