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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
Sponsor: Boston Children's Hospital
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).
Official 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
Key Details
Gender
All
Age Range
0 Years - 21 Years
Study Type
OBSERVATIONAL
Enrollment
250
Start Date
2026-03
Completion Date
2028-07
Last Updated
2026-03-16
Healthy Volunteers
No
Interventions
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.
Locations (1)
Boston Children's Hospital
Boston, Massachusetts, United States