Stroke and Traumatic Acute Brain Injury Line Indicator System for Emergent Recognition (STABILISER-I)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Ischemic Stroke
- Sponsor
- Justin Fraser
- Enrollment
- 48
- Locations
- 1
- Primary Endpoint
- Whole Blood Biomarker Results on the Visual Analog Scale
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
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.
Detailed Description
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).
Investigators
Justin Fraser
Asst Professor of Cerebrovascular, Endovascular, and Skull Base Surgery
University of Kentucky
Eligibility Criteria
Inclusion Criteria
- •Patients 21-85 years old, male or female.
- •Suspected TBI, acute ischemic stroke, or nontraumatic/nonlesional intracerebral hemorrhage (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.
- •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
- •Pregnant women as the effect of pregnancy on the biomarker testing result is as yet unknown.
- •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.
Outcomes
Primary Outcomes
Whole Blood Biomarker Results on the Visual Analog Scale
Time Frame: Within 8 hours of time of injury/onset of stroke symptoms.
Degree of response to a protein specific biomarker in whole blood as indicated by the Lateral Flow Device's analog scale: negative / mild / moderate / severe.
Secondary Outcomes
- Whole Blood Biomarker Results on the Visual Analog Scale(Within 48 ± 8 hours of time of injury/onset of stroke symptoms.)
- Serum Biomarker Results on the Visual Analog Scale(Within 48 ± 8 hours of time of injury/onset of stroke symptoms.)