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

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ClinicalTrials.gov Identifier: NCT02514902
Recruitment Status : Completed
First Posted : August 4, 2015
Last Update Posted : February 23, 2017
Sponsor:
Collaborator:
University of Kentucky
Information provided by (Responsible Party):
Justin Fraser, University of Kentucky

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.

Condition or disease Intervention/treatment Phase
Ischemic Stroke Hemorrhagic Stroke Traumatic Brain Injury Device: Lateral Flow Device Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Stroke and Traumatic Acute Brain Injury Line Indicator System for Emergent Recognition (STABILISER-I)
Actual Study Start Date : March 25, 2015
Actual Primary Completion Date : December 16, 2016
Actual Study Completion Date : December 16, 2016

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



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Ages Eligible for Study:   21 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02514902


Locations
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United States, Kentucky
University of Kentucky Deparment of Neurosurgery, UK Chandler Hospital
Lexington, Kentucky, United States, 40536-0298
Sponsors and Collaborators
Justin Fraser
University of Kentucky
Investigators
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Principal Investigator: Justin F. Fraser, MD University of Kentucky Department of Neurological Surgery

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Responsible Party: Justin Fraser, Asst Professor of Cerebrovascular, Endovascular, and Skull Base Surgery, University of Kentucky
ClinicalTrials.gov Identifier: NCT02514902    
Other Study ID Numbers: 15-0166-F6A
NIH UL1TR000117 ( Other Identifier: University of Kentucky CCTS High Impact Award )
First Posted: August 4, 2015    Key Record Dates
Last Update Posted: February 23, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Justin Fraser, University of Kentucky:
Lateral Flow Device (LFD)
Acute Stroke
Traumatic Brain Injury (TBI)
Point of Care (POC)
Biomarker
Additional relevant MeSH terms:
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Stroke
Brain Injuries
Brain Injuries, Traumatic
Wounds and Injuries
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Craniocerebral Trauma
Trauma, Nervous System