Evaluation of a Point-of-care Lateral Flow Assay in Glial Fibrillary Acidic Protein (GFAP) and D-dimer in Diagnosis of Large Vessel Occlusion Acute Ischemic Stroke in a Pediatric Hospital

March 12, 2026 updated by: Pok-meng See, Boston Children's Hospital

Evaluation of a Point-of-care Lateral Flow Assay in GFAP and D-dimer in Diagnosis of Large Vessel Occlusion Acute Ischemic Stroke in a Pediatric Hospital

The goal of this study is to test the efficacy of a rapid bedside blood test in determining if a stroke is happening in children who present to the emergency department with stroke symptoms. The main questions it aims to answer are:

  • To determine the sensitivity of detecting a large vessel occlusion (LVO) as the etiology of acute ischemic stroke (AIS) in a pediatric population using a point-of-care blood-based assay (LVOne).
  • To determine the positive predictive value (PPV) of LVOne in a pediatric population

Participants will:

  • Provide a small sample of blood to be used to test the accuracy of the device.
  • Participants will still receive all standard of care work-up for stroke, which could include computed tomography/magnetic resonance imaging (CT/MRI).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Neurologic emergencies, such as stroke, make up almost one-third of the most serious cases seen in pediatric emergency departments. Although stroke is less common in children than in adults, it is being diagnosed more often-especially in children under five years old-and it leads to much higher healthcare costs after the event. Despite how serious pediatric stroke can be, there is still no clear agreement on the best way to diagnose it quickly and safely.

One of the biggest challenges is that diagnosing stroke in children usually depends on advanced imaging tests like CT scans and MRI. CT scans expose children to radiation, which carries long-term risks, while MRI scans often require sedation and can be delayed due to limited availability. Even so, these tests are still needed to decide whether a child qualifies for treatments that can limit brain damage, such as clot-removal procedures. Any delay in diagnosis can significantly worsen outcomes. These problems are especially difficult in smaller or rural emergency departments, where children may need to be transferred to a specialized pediatric hospital-adding time, cost, and stress for families.

Because of these challenges, there is growing interest in simpler tests that could help doctors evaluate children more quickly. In particular, certain blood markers, such as GFAP and D-dimer, have been studied as possible indicators of stroke. While some blood tests for these markers have been approved for use in adults, they are often expensive and not widely available, and their usefulness in children is not well established. A newer option-called a lateral flow test, similar to a rapid pregnancy test-could offer a fast, low-cost, bedside alternative. Early studies in adults are encouraging. However, stroke is much less common in children: while most adults who arrive at the emergency department with sudden neurologic symptoms are having a stroke, only about 7% of children with similar symptoms actually are.

Although adult studies suggest that a rapid test using just a drop of blood from a finger prick may be able to detect certain types of stroke or rule out brain bleeding, this approach has not yet been properly studied in children. In this study, we aim to test whether a commercially available rapid bedside blood test can accurately help diagnose stroke in children who come to the emergency department with concerning symptoms.

Study Type

Observational

Enrollment (Estimated)

250

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Boston Children's Hospital
        • Sub-Investigator:
          • Rebekah Mannix, MD, MPH
        • Contact:
        • Sub-Investigator:
          • Laura Lehman, MD, MPH

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

  • Child
  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Participants will be included if they present to Boston Children's Hospital Emergency Department and present with justification of activating a code stroke, such as acute onset spontaneous focal neurologic deficit or altered consciousness.

Description

Inclusion Criteria:

  • Presenting with acute onset (<18 hours) spontaneous (no trauma) focal neurologic deficit or altered consciousness

Exclusion Criteria:

  • Participants with surgery in the past month
  • Participants with known trauma in the past month
  • Participants with known seizure history or anti-seizure medications
  • Participants who are adults with decisional impairment

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Stroke code patients in BCH ED
Any patient who presents to Boston Children's Hospital (BCH) Emergency Department (ED) and whose clinical evaluation justifies activation of a stroke code will be considered. Once identified, inclusion/exclusion criteria will be evaluated and if terms are satisfied, patient will be approached for consent.
Device: Point of Care Rapid Assay
In this study, participants will provide a small sample of blood to test the accuracy and efficacy of the Rapid Assay device. Standard of care for diagnosis will follow, regardless of Assay outcomes.
Other Names:
  • LVOne

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity of Device
Time Frame: From enrollment in study in the emergency department through completion of the diagnostic evaluation for stroke during the index ED visit (approximately up to 24 hours).
To determine the sensitivity of detecting an large vessel occlusion as the etiology of acute ischemic stroke.
From enrollment in study in the emergency department through completion of the diagnostic evaluation for stroke during the index ED visit (approximately up to 24 hours).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Positive Predictive Value
Time Frame: From enrollment in study in the emergency department through completion of the diagnostic evaluation for stroke during the index ED visit (approximately up to 24 hours).
To determine the Positive Predictive Value of LVOne for any imaging-confirmed acute ischemic stroke
From enrollment in study in the emergency department through completion of the diagnostic evaluation for stroke during the index ED visit (approximately up to 24 hours).
Positive Predictive Value of Large Vessel Occulusion
Time Frame: From enrollment in study in the emergency department through completion of the diagnostic evaluation for stroke during the index ED visit (approximately up to 24 hours).
To determine the Positive Predictive Value of LVOne for acute ischemic stroke with large vessel occlusion
From enrollment in study in the emergency department through completion of the diagnostic evaluation for stroke during the index ED visit (approximately up to 24 hours).
Specificity of device for stroke
Time Frame: From enrollment in study in the emergency department through completion of the diagnostic evaluation for stroke during the index ED visit (approximately up to 24 hours).
To determine the specificity of LVOne for any imaging-confirmed acute ischemic stroke
From enrollment in study in the emergency department through completion of the diagnostic evaluation for stroke during the index ED visit (approximately up to 24 hours).
Frequency of indeterminate results
Time Frame: From enrollment in study in the emergency department through completion of the diagnostic evaluation for stroke during the index ED visit (approximately up to 24 hours).
To identify the frequency of indeterminate readout on LVOne assay
From enrollment in study in the emergency department through completion of the diagnostic evaluation for stroke during the index ED visit (approximately up to 24 hours).

Collaborators and Investigators

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

Sponsor

Boston Children's Hospital

Investigators

  • Principal Investigator: Pok-meng See, MD, Boston Children's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Estimated)

March 1, 2026

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

July 1, 2028

Study Registration Dates

First Submitted

February 23, 2026

First Submitted That Met QC Criteria

March 12, 2026

First Posted (Actual)

March 16, 2026

Study Record Updates

Last Update Posted (Actual)

March 16, 2026

Last Update Submitted That Met QC Criteria

March 12, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P00051413

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

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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