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

Not Applicable

Completed

• Conditions: Ischemic Stroke; Hemorrhagic Stroke; Traumatic Brain Injury
• Interventions: Device: Lateral Flow Device

• Registration Number: NCT02514902
• Lead Sponsor: Justin Fraser

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).

Study Timeline

• Study Start: 2015-03-25
• Study First Submitted: 2015-07-29
• Study First Submitted QC: 2015-08-03
• Study First Posted: 2015-08-04
• Primary Completion: 2016-12-16
• Study Completion: 2016-12-16
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-20
• Last Update Posted: 2017-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lateral Flow Device	Lateral Flow Device	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.

Primary Outcome Measures

Name	Time	Method
Whole Blood Biomarker Results on the Visual Analog Scale	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 Outcome Measures

Name	Time	Method
Whole Blood Biomarker Results on the Visual Analog Scale	Within 48 ± 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.
Serum Biomarker Results on the Visual Analog Scale	Within 48 ± 8 hours of time of injury/onset of stroke symptoms.	Degree of response to a protein specific biomarker in serum as indicated by the Lateral Flow Device's analog scale: negative / mild / moderate / severe.

Trial Locations

Locations (1)

University of Kentucky Deparment of Neurosurgery, UK Chandler Hospital; 🇺🇸 Lexington, Kentucky, United States