Stroke and Traumatic Acute Brain Injury Line Indicator System for Emergent Recognition (STABILISER-I)

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).

Inclusion Criteria:

1. Patients 21-85 years old, male or female.

2. Suspected TBI, acute ischemic stroke, or nontraumatic/nonlesional ICH based on
clinical and radiographic evidence as determined and documented by the appropriate
service (Trauma Service or Neurosurgery Service for TBI; Neurology or Neurosurgery
Service for Stroke) at University of Kentucky.

3. Patients with impaired capacity may be included; as the pathology to be studied
(stroke or TBI) may impair their capacity (please see attached required documentation
regarding impaired capacity).

Exclusion Criteria:

1. Pregnant women as the effect of pregnancy on the biomarker testing result is as yet
unknown.

2. While patients may be included with the above listed diagnoses, they may be excluded
later if an alternate unlisted diagnosis is found to be the root cause of their
presentation. An example would be a patient initially thought to have a stroke, who
is discovered to be suffering from a seizure instead.