Clinical trial NCT02514902: Stroke and Traumatic Acute Brain Injury Line Indicator System for Emergent Recognition (STABILISER-I)
Official title: Stroke and Traumatic Acute Brain Injury Line Indicator System for Emergent Recognition (STABILISER-I)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ischemic Stroke
Hemorrhagic Stroke
Traumatic Brain Injury
Keywords: Lateral Flow Device (LFD)
Acute Stroke
Traumatic Brain Injury (TBI)
Point of Care (POC)
Biomarker
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: University of Kentucky
First posted: 2015-08-04
Enrollment: 48
Sex: ALL
Minimum age (years): 21
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

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).

Eligibility criteria: Inclusion Criteria:

1. Patients 21-85 years old, male or female.
2. 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.
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.

Primary outcomes:
measure: Whole Blood Biomarker Results on the Visual Analog Scale
timeFrame: Within 8 hours of time of injury/onset of stroke symptoms.
Secondary outcomes:
measure: Whole Blood Biomarker Results on the Visual Analog Scale
timeFrame: Within 48 ± 8 hours of time of injury/onset of stroke symptoms.
measure: Serum Biomarker Results on the Visual Analog Scale
timeFrame: Within 8 hours of time of injury/onset of stroke symptoms.
measure: Serum Biomarker Results on the Visual Analog Scale
timeFrame: Within 48 ± 8 hours of time of injury/onset of stroke symptoms.
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky Deparment of Neurosurgery, UK Chandler Hospital
state: Kentucky
Study officials:
affiliation: University of Kentucky Department of Neurological Surgery
name: Justin F. Fraser, MD
role: PRINCIPAL_INVESTIGATOR
References: