TRACK-TBI study shows i-STAT Alinity device identifies brain injury even if a CT scan is normal

Abbott announced that a new study, published in Lancet Neurology, found that elevated levels of a protein measured with the company's blood test under development could help detect mild traumatic brain injuries (TBIs), even when a CT scan did not detect it. Findings from the Transforming Research and Clinical Knowledge in Traumatic Brain Injury (TRACK-TBI) study – one of the largest TBI efforts of its kind – show this new technology could help fill a gap in emergency rooms today by identifying patients who might otherwise have gone undiagnosed.

Researchers from TRACK-TBI evaluated 450 patients admitted to the emergency department of 18 U.S. Level 1 trauma centers with a suspected TBI, who also received a negative CT scan, to determine if the brain-specific glial fibrillary acidic protein (GFAP) could be a biomarker, or indication, that helps physicians detect TBIs. The study used Abbott's i-STAT Alinity device – a handheld, portable blood analyzer that produces test results in minutes right by a person's side – and its blood test under development to measure a patient's GFAP protein level.The i-STAT Alinity device is available outside of the U.S with a CE Mark. and is not yet commercially available in the U.S.

Among these 450 participants with a negative CT scan, researchers evaluated GFAP levels in their blood and then reviewed their MRI scans taken up to two weeks later to confirm the TBI. When looking at the people who had detectable levels of this protein, the study found that among the 90 people with the highest levels of GFAP detected, 64% were confirmed to have a TBI by the MRI scan. By contrast, for the 90 people with the lowest levels of GFAP, 8% were confirmed to have a TBI. The research showed that GFAP could be used to determine which group of people should be screened further or referred for an MRI to confirm their TBI.

Researchers found that GFAP levels: Were significantly higher in patients who had a positive MRI but a negative CT scan, compared to people with both negative CT and MRI scans.. Could potentially be used to predict the type of damage, as well as the extent of injury. Were not significantly elevated in the control groups of healthy individuals as well as those who had only orthopedic injuries.

The study also looked at three additional brain biomarkers to assess any association between elevated levels of those proteins and brain injury: S100 calcium-binding protein B (S100B); ubiquitin C-terminal hydrolase L1 (UCH-L1); and neuron-specific enolase (NSE) protein. Researchers found that elevated GFAP levels were more sensitive for detecting brain injury in patients with a negative CT scan than were elevated levels of UCH-L1, S100B or NSE..

About the study : The research, published online August 23, 2019 in Lancet Neurology, is part of TRACK-TBI, a prospective, multi-center observational study. The study enrolled TBI patients receiving a head CT within 24 hours of injury at 18 U.S. Level 1 trauma centers. As part of this sub-analysis, researchers evaluated 450 participants who each received a CT scan that was read by a radiologist as negative for TBI, a blood draw within 24 hours, and an MRI within seven to 18 days post injury. Of these 450 participants with a negative CT scan, nearly all cases (99.1%) were classified as mild TBIs, and mainly resulted from traffic accident (67%) or incidental fall (20%).

About TRACK-TBI : The Transforming Research and Clinical Knowledge in Traumatic Brain Injury Network (TRACK-TBI NET) is a collaborative research effort of observational and interventional studies funded by the National Institute of Neurological Disorders and Stroke (NINDS), the U.S. Department of Defense (DoD) through U.S. Army Medical Research and Development Command (USAMRDC) and U.S. Army Medical Materiel Development Activity (USAMMDA), with support from private and philanthropic partners. TRACK-TBI NET evolved from the TRACK-TBI study, the largest and most comprehensive precision natural history study of TBI ever conducted in the U.S. The foundational observational study enrolled more than 3,000 participants across age (0-100 years old) and injury spectra from concussion to coma, including those with TBI, and orthopedic and healthy control comparison groups, at 18 U.S. Level 1 trauma center study sites.

See- Yue JK, Yuh EL, Korley FK, et al. Lancet Neurol 2019; published online Aug 23. http://dx.doi.org/10.1016/S1474-4422(19)30282-0.