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

Recruiting

Phase 1 Results N/A

Trial Description

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).

Conditions

Interventions

  • Lateral Flow Device Device
    Intervention Desc: A drop of whole blood from a finger stick is placed on the lateral flow device at two different time points to indicate the presence of a neuronal specific biomarker. The results will also be correlated to severity of clinical and radiographic injury. Separate drops are evaluated similarly for serum levels. The objective is to determine feasibility of a diagnostic tool for stroke (ischemic and hemorrhagic and traumatic brain injury (TBI). No diagnostic results or resulting treatments will be applied to any subject.
    ARM 1: Kind: Experimental
    Label: Lateral Flow Device
    Description: Determine the feasibility of testing whole blood samples from 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. No diagnostic or treatment decisions will be based on the results for any patient and the patient will not be told of the results.

Trial Design

  • Masking: Open Label
  • Purpose: Basic Science
  • Intervention: Single Group Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Whole Blood Biomarker Results on the Visual Analog Scale Within 8 hours of time of injury/onset of stroke symptoms. No
Primary Serum Biomarker Results on the Visual Analog Scale Within 8 hours of time of injury/onset of stroke symptoms. No

Sponsors