A new rapid test produces lab quality results using whole blood to identify biomarkers associated with mild traumatic brain injury, otherwise known as concussion.
The results could help forward-deployed medics and health care providers at battalion aid stations and field hospitals decide which wounded service members they need to treat first and who needs to be evacuated from the field.
Having a simple and fieldable test for mild TBI is critical to providing timelier high-quality care for the Military Health System. More than 492,000 U.S. service members worldwide sustained a TBI resulting from military training, deployment, or day-to-day activities—such as sporting events—from November 2000–2023, according to statistics compiled by the Defense Health Agency Traumatic Brain Injury Center of Excellence and reported in the TBICoE 2023 annual report released on March 29, 2024.
Improving TBI Testing in Future Conflicts
The test, cleared for use by the U.S. Food and Drug Administration in March 2024, is one of the most significant steps forward in the care of TBI patients in the past 20 years, according to neuroscientist U.S. Army Lt. Col. (Dr.) Bradley Dengler, director of the Military Traumatic Brain Injury Initiative at the Uniformed Services University in Bethesda, Maryland.
Previous tests to help diagnose concussion or more severe TBI were cleared by FDA in early 2021 only for use with blood plasma or serum. This required samples to be sent to a laboratory for processing and results.
The new test, which takes only 15 minutes for results and is run on a portable device, also can be used to evaluate patients up to 24 hours after injury, a significant improvement from previously available tests. The device therefore could aid in decisions on priority evacuations from forward deployments in a future conflict where rapid evacuation (the “golden hour”) is not possible.
“Given the large numbers of expected casualties with all severities of traumatic brain injury in future large-scale combat operations, this test can help maintain combat power far forward by helping to eliminate unnecessary evacuations,” Dengler said.
“Additionally, and just as important, given the limited number of neurosurgeons available in-theater, ongoing research demonstrates that a future version of this test could be used to triage more severely injured patients, as the blood biomarker elevations correlate with the severity of their intracranial injuries,” Dengler commented. “This can help get the most severely injured service members to neurosurgeons faster and ultimately save lives.”
MTBI2 is the only military health organization that conducts clinical trials and translational research spanning all TBIs—mild to severe—and focuses on acute and subacute phases. Dengler also serves as the neurosurgical consultant to the U.S. Army surgeon general.
U.S. Army Plays Key Development Role
The U.S. Army Medical Research and Development Command, headquartered at Fort Detrick in Frederick, Maryland, has been dedicated to developing a solution for detecting and evaluating TBIs for more than two decades.
The new diagnostic method will prevent unnecessary medical evacuations and improve TBI case management in the field since not all patients will require head CT scans, said U.S. Army Col. Andy Nuce, commander of the U.S. Army Medical Materiel Development Activity, part of USAMRDC.
In July 2023, the technology was tested in simulated battle conditions during a soldier “touchpoint” as part of the Global Medic combat support training exercise at the U.S. Army’s Fort Hunter Liggett, California, which is known as the military's premier total force training center.
Program experts from USAMMDA’s Warfighter Brain Health Project Management Office and Warfighter Deployed Medical Systems Project Management Office joined leaders with USAMRDC and the Medical Capability Development Integration Directorate to participate in the field trial. Subject matter experts from USAMMDA, the Combat Casualty Care Research Program, and the Walter Reed Army Institute of Research also participated in the program’s development.
"TBIs are a major concern for warfighter health, readiness, and resiliency,” said U.S. Army Brig. Gen. (Dr.) Edward H. Bailey, commanding general of USAMRDC. “This milestone demonstrates how Army medical developers can partner with industry to deliver solutions for frontline medical personnel caring for our injured service members.”
U.S. Army officials, in partnership with medical device manufacturer Abbott, jointly announced April 1, 2024, that the company’s i-STAT® TBI whole blood cartridge had received FDA marketing clearance. Abbott developed the blood test in collaboration with USAMMDA.
The Transforming Research and Clinical Knowledge in Traumatic Brain Injury (TRACK-TBI) research team was the first to demonstrate how the TBI blood test could be used to benefit TBI patients in clinical care. Spanning the USAMRDC and broader Department of Defense community, these multifaceted teams were unified by the common goal of developing a TBI product that meets the needs of the warfighter.
“During future large-scale combat operations, enemy weapons and exposure to blast or concussive events will present challenges to frontline medical providers,” USAMMDA’s Nuce said. “We are constantly working to investigate, develop, and field modern medical solutions to protect the warfighters of 2030, 2040, and beyond.”
USAMMDA takes promising medical technology from DHA, industry, and academia to U.S. forces. It develops critical drugs, vaccines, biologics, devices, and medical support equipment, from the testing required for FDA approval or licensing to field trials and sustainment of the finished product.