NCT07474675

Brief 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).

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
24mo left

Started Mar 2026

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress12%
Mar 2026Jul 2028

First Submitted

Initial submission to the registry

February 23, 2026

Completed
6 days until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 16, 2026

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2028

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2028

Last Updated

March 16, 2026

Status Verified

March 1, 2026

Enrollment Period

1.8 years

First QC Date

February 23, 2026

Last Update Submit

March 12, 2026

Conditions

Stroke CodeLarge Vessel OcclusionAcute Ischemic Stroke

Keywords

Stroke

Outcome Measures

Primary Outcomes (1)

  • Sensitivity of Device

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

    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)

  • Positive Predictive Value

    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).

  • Positive Predictive Value of Large Vessel Occulusion

    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).

  • Specificity of device for stroke

    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).

  • Frequency of indeterminate results

    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).

Study Arms (1)

Stroke code patients in BCH ED

Any 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.

Device: Point of Care Rapid Assay

Interventions

Point of Care Rapid AssayDEVICE

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.

Also known as: LVOne
Stroke code patients in BCH ED

Eligibility Criteria

Age0 Years - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (4)

  • 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.

    PMID: 39122395BACKGROUND

  • 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.

    PMID: 33930055BACKGROUND

  • 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.

    PMID: 20022340BACKGROUND

  • 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.

    PMID: 23260102BACKGROUND

MeSH Terms

Conditions

Ischemic StrokeStroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Pok-meng See, MD

    Boston Children's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Adam Porter, MPH

CONTACT

617-919-6013adam.porter@childrens.harvard.edu

Thomas Stivers, MS

CONTACT

thomas.stivers@childrens.harvard.edu

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Neurosurgery, Harvard Medical School

Study Record Dates

First Submitted

February 23, 2026

First Posted

March 16, 2026

Study Start

March 1, 2026

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

July 1, 2028

Last Updated

March 16, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)