[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100629438":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":26,"locations":35,"responsibleParty":55,"collaborators":10,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":10,"eligibilityCriteria":64,"healthyVolunteers":60,"sex":65,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":10,"studyType":71,"phases":10,"briefSummary":72,"conditions":73,"keywords":77,"overallStatus":79,"whyStopped":10,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"Boston Children's Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Stroke code patients in BCH ED",null,"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\u002Fexclusion criteria will be evaluated and if terms are satisfied, patient will be approached for consent.",[13],"Device: Point of Care Rapid Assay",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","Point of Care Rapid Assay","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.",[9],[21],"LVOne",[23],{"name":24,"affiliation":5,"role":25},"Pok-meng See, MD","PRINCIPAL_INVESTIGATOR",[27,32],{"name":28,"role":29,"phone":30,"phoneExt":10,"email":31},"Adam Porter, MPH","CONTACT","617-919-6013","adam.porter@childrens.harvard.edu",{"name":33,"role":29,"phone":10,"phoneExt":10,"email":34},"Thomas Stivers, MS","thomas.stivers@childrens.harvard.edu",[36],{"facility":5,"status":10,"city":37,"state":38,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Boston","Massachusetts","02115","United States","US",{"type":43,"coordinates":44},"Point",[45,46],-71.05977,42.35843,{"lat":46,"lon":45},[49,50,53],{"name":28,"role":29,"phone":30,"phoneExt":10,"email":31},{"name":51,"role":52,"phone":10,"phoneExt":10,"email":10},"Rebekah Mannix, MD, MPH","SUB_INVESTIGATOR",{"name":54,"role":52,"phone":10,"phoneExt":10,"email":10},"Laura Lehman, MD, MPH",{"type":25,"investigatorFullName":56,"investigatorTitle":57,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Pok-meng See","Assistant Professor of Neurosurgery, Harvard Medical School","100629438","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-100629438",false,"NCT07474675","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","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","Inclusion Criteria:\n\n* Presenting with acute onset (\\\u003C18 hours) spontaneous (no trauma) focal neurologic deficit or altered consciousness\n\nExclusion Criteria:\n\n* Participants with surgery in the past month\n* Participants with known trauma in the past month\n* Participants with known seizure history or anti-seizure medications\n* Participants who are adults with decisional impairment","ALL","0 Years","21 Years",{"count":69,"type":70},250,"ESTIMATED","OBSERVATIONAL","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:\n\n* 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).\n* To determine the positive predictive value (PPV) of LVOne in a pediatric population\n\nParticipants will:\n\n* Provide a small sample of blood to be used to test the accuracy of the device.\n* Participants will still receive all standard of care work-up for stroke, which could include computed tomography\u002Fmagnetic resonance imaging (CT\u002FMRI).",[74,75,76],"Stroke Code","Large Vessel Occlusion","Acute Ischemic Stroke",[78],"Stroke","NOT_YET_RECRUITING","2026-03-12",{"date":82,"type":83},"2026-03-16","ACTUAL",{"date":85,"type":70},"2026-03",{"date":87,"type":70},"2028-07",{"name":5,"class":6},1]