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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:
Participants will:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Point of Care Rapid Assay | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Positive Predictive Value | To determine the Positive Predictive Value of LVOne for any imaging-confirmed 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). |
| Positive Predictive Value of Large Vessel Occulusion |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Adam Porter, MPH | Contact | 617-919-6013 | adam.porter@childrens.harvard.edu | |
| Thomas Stivers, MS | Contact | thomas.stivers@childrens.harvard.edu |
| Name | Affiliation | Role |
|---|---|---|
| Pok-meng See, MD | Boston Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston Children's Hospital | Boston | Massachusetts | 02115 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39122395 | Background | 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. | |
| 33930055 | Background | 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. |
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|
To determine the Positive Predictive Value of LVOne for acute ischemic stroke with large vessel occlusion |
| 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 | 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 | 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). |
| 20022340 | Background | 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. |
| 23260102 | Background | 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. |
| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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