Traumatic Brain Injury Clinical Trial
Official title:
Stroke and Traumatic Acute Brain Injury Line Indicator System for Emergent Recognition (STABILISER-I)
In the search for a novel marker of stroke that could be rapidly assessed in blood, the investigators developed a point-of-care (POC) lateral flow device (LFD) that rapidly (< 15 min) detects levels of a biomarker that is released into blood following neuronal injury associated with stroke and traumatic brain injury. The protein's expression in human brain should serve as a useful biomarker of neuronal injury in stroke and traumatic brain injury.
The use of a lateral flow device (LFD) to indicate the presence of a blood biomarker is
feasible and may provide an important diagnostic tool for stroke and traumatic brain injury
(TBI).
Primary Objectives:
1. Determine the first-in-humans feasibility using the investigators' biomarker lateral
flow device on whole blood samples to diagnose patients with acute stroke (both
ischemic and hemorrhagic) and traumatic brain injury being evaluated in the Emergency
Department and Inpatient Services at University of Kentucky. Provide initial pilot data
for estimating sensitivity and specificity of the assay.
2. Establish a visual ordinal grading scale that is easy to use clinically to judge the
severity of injury, from the Lateral Flow Device result. Verify that the visual scale
has inter-rater reliability, and evaluate it against a digital detection assay.
3. Examine the correlation between clinical and radiographic parameters of injury severity
and blood levels of the biomarker. The investigators will correlate the results of the
test with NIH Stroke Scale and with MRI infarct volume for ischemic stroke, with
hemorrhage volume on CT for hemorrhagic stroke, and with Glasgow Coma Scale for
Traumatic Brain Injury (TBI).
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