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NCT Number: NCT07474675

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

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).

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Key information

Age range

0 year–21 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location contact

Adam Porter, MPH

CONTACT

[email protected]

617-919-6013

Laura Lehman, MD, MPH

SUB_INVESTIGATOR

Rebekah Mannix, MD, MPH

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Point of Care Rapid Assay

Device

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Adam Porter, MPH

CONTACT

[email protected]

617-919-6013

Thomas Stivers, MS

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Boston Children's Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Mar 16, 2026
Registry last updated
Mar 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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