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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

NCT07474675 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 250

Last updated 2026-03-16

No results posted yet for this study

Summary

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).

Conditions

  • Stroke Code
  • Large Vessel Occlusion
  • Acute Ischemic Stroke

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Pok-meng See, MD · Boston Children's Hospital

Eligibility

Min Age
0 Years
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-31
Primary Completion
2028-01-31
Completion
2028-07-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT07474675 on ClinicalTrials.gov