NCT02514902

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 25, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 29, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 4, 2015

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 16, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 16, 2016

Completed
Last Updated

February 23, 2017

Status Verified

February 1, 2017

Enrollment Period

1.7 years

First QC Date

July 29, 2015

Last Update Submit

February 20, 2017

Conditions

Ischemic StrokeHemorrhagic StrokeTraumatic Brain Injury

Keywords

Lateral Flow Device (LFD)Acute StrokeTraumatic Brain Injury (TBI)Point of Care (POC)Biomarker

Outcome Measures

Primary Outcomes (1)

  • Whole Blood Biomarker Results on the Visual Analog Scale

    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 Outcomes (3)

  • Whole Blood Biomarker Results on the Visual Analog Scale

    Within 48 ± 8 hours of time of injury/onset of stroke symptoms.

  • Serum Biomarker Results on the Visual Analog Scale

    Within 8 hours of time of injury/onset of stroke symptoms.

  • Serum Biomarker Results on the Visual Analog Scale

    Within 48 ± 8 hours of time of injury/onset of stroke symptoms.

Study Arms (1)

Lateral Flow Device

EXPERIMENTAL

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

Interventions

Lateral Flow DeviceDEVICE

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.

Lateral Flow Device

Eligibility Criteria

Age21 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients 21-85 years old, male or female.
  • 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.
  • 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).

You may not qualify if:

  • Pregnant women as the effect of pregnancy on the biomarker testing result is as yet unknown.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kentucky Deparment of Neurosurgery, UK Chandler Hospital

Lexington, Kentucky, 40536-0298, United States

Location

MeSH Terms

Conditions

Ischemic StrokeHemorrhagic StrokeBrain Injuries, TraumaticStroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesBrain InjuriesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Justin F. Fraser, MD

    University of Kentucky Department of Neurological Surgery

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Asst Professor of Cerebrovascular, Endovascular, and Skull Base Surgery

Study Record Dates

First Submitted

July 29, 2015

First Posted

August 4, 2015

Study Start

March 25, 2015

Primary Completion

December 16, 2016

Study Completion

December 16, 2016

Last Updated

February 23, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)