Clinical Trial Evaluates Point-of-Care Blood Test for Concussion

The US Department of Defense (DoD) and the Transforming Research and Clinical Knowledge in Traumatic Brain Injury (TRACK-TBI) Network have announced a joint clinical trial in order to evaluate the effectiveness of Abbott’s point-of-care blood test technology, designed to assess brain injuries within minutes using a few drops of a patient’s blood.

According to a press release, more than 380,000 military members have sustained traumatic brain injuries (TBIs) over the past 20 years. The new point-of-care, portable blood test is set to assist in the assessment of brain injury right by the patient’s side with objectivity and speed.

"Traumatic brain injury is a significant health issue affecting both active service members and veterans, and we are committed to developing solutions for those impacted by brain injury," said Krista Caudle, Ph.D., project manager, Neurotrauma and Psychological Health Project Management Office, US Army Medical Materiel Development Activity (USAMMDA), in a prepared statement. "Having a portable biomarker technology will give clinicians an objective measure of a soldier's brain injury in a matter of minutes and could potentially impact the care they receive when they are evaluated and treated."

The blood test would potentially measure 2 types of proteins, GFAP and UCH-L1, that are released into the blood from the brain when it is injured. These blood biomarkers have been researched for more than a decade for their ability to help assess TBI in both the military and the general public.

The clinical trial will analyze the effectiveness of blood-biomarkers through data collected from patients in trauma centers across the country and an FDA-approved blood test that detects brain injury within 12 hours of a traumatic event. As part of this clinical trial, researchers will evaluate people with suspected TBI within 24 hours of injury and compare their blood test results against traditional clinical assessments, computerized tomography (CT) scans, magnetic resonance imaging (MRI) scans and clinical outcomes.

"Whether on the battlefield or in the emergency room, we need quick and accurate information to help assess a person who may have sustained brain injury," said Geoffrey T. Manley, MD, PhD, principal investigator of TRACK-TBI, neurosurgeon and professor of neurosurgery, University of California, San Francisco (UCSF). "Our goal with this partnership is to validate the scientific rigor behind new technologies, like this blood test, and how they can help ensure the best care for our troops and patients."

Reference

Abbott, the US Department of Defense and TRACK-TBI Partner to Study Point-of-Care Blood Test for Concussions [news release]. Abbott website. Published 30, 2019.https://abbott.mediaroom.com/2019-04-30-Abbott-the-U-S-Department-of-Defense-and-TRACK-TBI-Partner-to-Study-Point-of-Care-Blood-Test-for-Concussions. Accessed May 1, 2019.