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Testing a quick bedside blood test for stroke in children at a children's hospital

Tests a quick blood test to spot stroke in children with stroke symptoms.

Plain-language title generated from the registry record
Registry title: 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

Key facts

Where
Boston, United StatesSee the site

Could this be for you?

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 0 and 21 years old?

Source: NCT07474675, who can take part

Where in United States

  • Boston Children's HospitalBoston, United StatesNo longer taking part

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
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Trial details

Who runs it
Boston Children's Hospital
Trial code
NCT07474675
Record updated
16 March 2026
Original description
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:Read full original descriptionShow less

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

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).

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 seizure history or anti-seizure medications; Participants who are adults with decisional impairment; Participants with known trauma in the past month.

ClinicalTrials.gov NCT07474675