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

NCT02514902 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2017-02-23

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • University of Kentucky

    collaborator OTHER

  • Justin Fraser

    lead OTHER

Principal Investigators

  • Justin F. Fraser, MD · University of Kentucky Department of Neurological Surgery

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-03-25
Primary Completion
2016-12-16
Completion
2016-12-16

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02514902 on ClinicalTrials.gov