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NCT07474675Not yet recruiting

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

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

Source: ClinicalTrials.gov · Last updated 16 Mar 2026

Brief summary (registry, in English)

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).

Status (registry)
Not yet recruiting
Study type
Observational
Enrollment
250 (estimated)
First submitted
23 Feb 2026
Start date
Mar 2026
Primary completion date
Jan 2028
Lead sponsor
Boston Children's Hospital
Diseases
Stroke
NCT number
NCT07474675

What you commit to

  • Study type: Observational
  • Planned participants: 250
  • From Mar 2026 to the primary completion date, Jan 2028
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Participants with surgery in the past month

Other illness

  • Participants with known seizure history or anti-seizure medications
  • Participants who are adults with decisional impairment

Other

  • Participants with known trauma in the past month

Who the study is looking for

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

Age in the registry: 0 years to 21 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Boston Children's Hospital
Coordinator of this site? Confirm its status
BostonUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.