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

February 20, 2017 updated by: Justin Fraser
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kentucky
      • Lexington, Kentucky, United States, 40536-0298
        • University of Kentucky Deparment of Neurosurgery, UK Chandler Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Device: Lateral Flow Device
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Within 8 hours of time of injury/onset of stroke symptoms.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Whole Blood Biomarker Results on the Visual Analog Scale
Time Frame: 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.
Within 48 ± 8 hours of time of injury/onset of stroke symptoms.
Serum 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 serum as indicated by the Lateral Flow Device's analog scale: negative / mild / moderate / severe.
Within 8 hours of time of injury/onset of stroke symptoms.
Serum Biomarker Results on the Visual Analog Scale
Time Frame: 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.
Within 48 ± 8 hours of time of injury/onset of stroke symptoms.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Justin Fraser

Collaborators

University of Kentucky

Investigators

  • Principal Investigator: Justin F. Fraser, MD, University of Kentucky Department of Neurological Surgery

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 25, 2015

Primary Completion (Actual)

December 16, 2016

Study Completion (Actual)

December 16, 2016

Study Registration Dates

First Submitted

July 29, 2015

First Submitted That Met QC Criteria

August 3, 2015

First Posted (Estimate)

August 4, 2015

Study Record Updates

Last Update Posted (Actual)

February 23, 2017

Last Update Submitted That Met QC Criteria

February 20, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-0166-F6A
  • NIH UL1TR000117 (Other Identifier: University of Kentucky CCTS High Impact Award)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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