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Evaluating a Rapid Blood Test for Pediatric Stroke

This study is testing a new, rapid blood test called a Point of Care Rapid Assay (LVOne) to see how well it can help doctors quickly diagnose a type of stroke called large vessel occlusion acute ischemic stroke (LVO AIS) in children. This test aims to provide faster answers than traditional imaging like CT or MRI, which can be slow and have risks for children. The study wants to see how accurate this blood test is at finding LVO AIS in children who come to the emergency department with stroke symptoms. You could participate if you are between 0 and 21 years old, have new stroke-like symptoms, and haven't had recent surgery, trauma, or a history of seizures. The study plans to enroll 250 participants.

Study design
This is an observational study involving 250 participants. It is not specified if it is randomized or blinded.
What's involved
You would provide a small blood sample for the Rapid Assay device. You will still receive all standard medical care for stroke diagnosis, including CT or MRI scans.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, sensitivity of the device, is measured from enrollment in the emergency department through the completion of the diagnostic evaluation for stroke during that visit (approximately up to 24 hours).

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07474675

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

Not Yet Recruiting
Not specifiedAges 0–21Observational
Boston Children's Hospital
~250 participants
Updated 2026-03-16 on ClinicalTrials.gov
What's tested:Point of Care Rapid Assay

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Sensitivity of Device
Measured over From enrollment in study in the emergency department through completion of the diagnostic evaluation for stroke during the index ED visit (approximately up to 24 hours).

Conditions

Stroke Code
Large Vessel Occlusion
Acute Ischemic Stroke

Explore related trials

Acute Ischemic StrokeLarge Vessel Occlusion

NCT07474675

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Boston Children's Hospital

    Boston, Massachusettsstudy coordinator listed

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Pok-meng See, MD · PRINCIPAL_INVESTIGATOR · Boston Children's Hospital

Who to contact

Adam Porter, MPH
[email protected]
617-919-6013
Email the study team

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Eligibility criteria

Inclusion

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

Exclusion

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

What this trial measures

  • Sensitivity of DeviceFrom enrollment in study in the emergency department through completion of the diagnostic evaluation for stroke during the index ED visit (approximately up to 24 hours).

    To determine the sensitivity of detecting an large vessel occlusion as the etiology of acute ischemic stroke.