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.
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
- Conditions the study is for
- Stroke Code, Large Vessel Occlusion, Acute Ischemic Stroke
- 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.
Thomas Stivers, MS contact
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
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.
- Conditions
- Stroke Code, Large Vessel Occlusion, Acute Ischemic Stroke
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Point of Care Rapid Assay |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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).
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).
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).
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.
- First posted16 Mar 2026
- Study startMar 2026 (estimated)
- Primary completionJan 2028 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Stroke CodeStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pok-meng See, Boston Children's Hospital
- Investigators
- Pok-meng See, MD, Principal investigator, Boston Children's Hospital
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 39122395Manyelo 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 33930055Bernard 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 20022340Goldenberg 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