Clinical Trial

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

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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).
Trial Details
NCT Number NCT07474675
Lead Sponsor Boston Children's Hospital
Conditions Stroke Code, Large Vessel Occlusion, Acute Ischemic Stroke
Enrollment 250 participants
Start Date 2026-03
Primary Completion 2028-01 (estimated)
Study Completion 2028-07 (estimated)
Updated on ClinicalTrials.gov 2026-03-16