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
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).
Description
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 sca…
Eligibility
- Age range
- 0–21 years
- Sex
- All
- Healthy volunteers
- No
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
Interventions
- DevicePoint 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.
Location
- Boston Children's HospitalBoston, Massachusetts