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Stroke CodeNCT07474675

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

An observational study of Stroke Code and Large Vessel Occlusion, run by Boston Children's Hospital at 1 site in United States.

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Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

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Official record

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Trial 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. Read more about this study

Who is it for?
Ages 0 to 21 years
What is being tested?
Point of Care Rapid Assay
Type of treatment
Medical device
How many people
250 participants
Where
1 siteUnited States
Study dates
Mar 2026to Jul 2028
Phase
Observational

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 0 to 21 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Study population: Participants will be included if they present to Boston Children's Hospital Emergency Department and present with justification of activating a code stroke, such as acute onset spontaneous focal neurologic deficit or altered consciousness.

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site
  • Boston Children's Hospital

    Boston, Massachusetts, 02115

    Adam Porter, MPH, 617-919-6013, adam.porter@childrens.harvard.edu

    Rebekah Mannix, MD, MPH

Other trials in United States

About this study

Official title: 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
Read more

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).
Read the detailed 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 scans expose children to radiation, which carries long-term risks, while MRI scans often require sedation and can be delayed due to limited availability. Even so, these tests are still needed to decide whether a child qualifies for treatments that can limit brain damage, such as clot-removal procedures. Any delay in diagnosis can significantly worsen outcomes. These problems are especially difficult in smaller or rural emergency departments, where children may need to be transferred to a specialized pediatric hospital-adding time, cost, and stress for families.

Because of these challenges, there is growing interest in simpler tests that could help doctors evaluate children more quickly. In particular, certain blood markers, such as GFAP and D-dimer, have been studied as possible indicators of stroke. While some blood tests for these markers have been approved for use in adults, they are often expensive and not widely available, and their usefulness in children is not well established. A newer option-called a lateral flow test, similar to a rapid pregnancy test-could offer a fast, low-cost, bedside alternative. Early studies in adults are encouraging. However, stroke is much less common in children: while most adults who arrive at the emergency department with sudden neurologic symptoms are having a stroke, only about 7% of children with similar symptoms actually are.

Although adult studies suggest that a rapid test using just a drop of blood from a finger prick may be able to detect certain types of stroke or rule out brain bleeding, this approach has not yet been properly studied in children. In this study, we aim to test whether a commercially available rapid bedside blood test can accurately help diagnose stroke in children who come to the emergency department with concerning symptoms.

Being tested
Point of Care Rapid Assay
Keywords
Stroke
Medical subject headings
Ischemic Stroke, Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Point of Care Rapid AssayDevice

    Also called LVOne

    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.

Study groups in NCT07474675
Study groupRoleWhat they receive
Stroke code patients in BCH EDAny patient who presents to Boston Children's Hospital (BCH) Emergency Department (ED) and whose clinical evaluation justifies activation of a stroke code will be considered. Once identified, inclusion/exclusion criteria will be evaluated and if terms are satisfied, patient will be approached for consent.
Receives: Device: Point of Care Rapid Assay

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Sensitivity of Device

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

    Measured: 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).

Secondary outcomes (4)
  1. Positive Predictive Value

    To determine the Positive Predictive Value of LVOne for any imaging-confirmed acute ischemic stroke

    Measured: 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).

  2. Positive Predictive Value of Large Vessel Occulusion

    To determine the Positive Predictive Value of LVOne for acute ischemic stroke with large vessel occlusion

    Measured: 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).

  3. Specificity of device for stroke

    To determine the specificity of LVOne for any imaging-confirmed acute ischemic stroke

    Measured: 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).

  4. Frequency of indeterminate results

    To identify the frequency of indeterminate readout on LVOne assay

    Measured: 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).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Mar 2026
  2. Study startMar 2026 (estimated)
  3. Primary completionJan 2028 (estimated)
  4. Study completionJul 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
250 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07474675
Sponsor's protocol ID
P00051413
Status last verified
Mar 2026
First submitted
23 Feb 2026
Last updated
16 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Shaw L, Burgess D, Dixit A, Gaude E, Lendrem C, McClelland G, White P, Williams C, Zhu G, Price C. Rapid Assay Diagnostic for Acute Stroke Recognition (RADAR): study protocol for a diagnostic accuracy study. BMJ Open. 2024 Aug 9;14(8):e087130. doi: 10.1136/bmjopen-2024-087130.

    PubMed 39122395
  • Manyelo CM, Chegou NN, Seddon JA, Snyders CI, Mutavhatsindi H, Manngo PM, Walzl G, Stanley K, Solomons RS. Serum and cerebrospinal fluid host proteins indicate stroke in children with tuberculous meningitis. PLoS One. 2021 Apr 30;16(4):e0250944. doi: 10.1371/journal.pone.0250944. eCollection 2021.

    PubMed 33930055
  • Bernard TJ, Fenton LZ, Apkon SD, Boada R, Wilkening GN, Wilkinson CC, Soep JB, Miyamoto SD, Tripputi M, Armstrong-Wells J, Benke TA, Manco-Johnson MJ, Goldenberg NA. Biomarkers of hypercoagulability and inflammation in childhood-onset arterial ischemic stroke. J Pediatr. 2010 Apr;156(4):651-6. doi: 10.1016/j.jpeds.2009.10.034. Epub 2009 Dec 21.

    PubMed 20022340
  • Goldenberg NA, Jenkins S, Jack J, Armstrong-Wells J, Fenton LZ, Stence NV, Oleszek J, Boada R, Wilkening GN, Wilkinson C, Soep JB, Miyamoto SD, Bajaj L, Mourani PM, Manco-Johnson MJ, Bernard TJ. Arteriopathy, D-dimer, and risk of poor neurologic outcome in childhood-onset arterial ischemic stroke. J Pediatr. 2013 May;162(5):1041-6.e1. doi: 10.1016/j.jpeds.2012.11.035. Epub 2012 Dec 20.

    PubMed 23260102

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