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

Starting soon

Conditions studied: Stroke Code, Large Vessel Occlusion, Acute Ischemic Stroke

In brief

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).

Key facts

Study ID

NCT07474675

Run by

Boston Children's Hospital

People needed

250

Starts

2026-03-01

Expected to finish

2028-07-01

Last updated by the study team

2026-03-16

Who can join

Age: any, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• Boston Children's Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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