[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100610725":3},{"organization":4,"outcomesModule":7,"designInfo":35,"detailedDescription":11,"studyPopulation":37,"armGroups":11,"interventions":38,"overallOfficials":11,"centralContacts":43,"locations":52,"responsibleParty":100,"collaborators":11,"id":102,"slug":11,"hasResults":103,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":107,"eligibilityCriteria":108,"healthyVolunteers":103,"sex":109,"minAge":110,"maxAge":11,"enrollmentInfo":111,"targetDuration":11,"studyType":114,"phases":11,"briefSummary":115,"conditions":116,"keywords":11,"overallStatus":118,"whyStopped":11,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":128},{"fullName":5,"class":6},"The George Institute","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":31},[9],{"measure":10,"description":11,"timeFrame":12},"Proportion of participants without ICH on hospital-based brain CT who are correctly identified as negative based on GFAP point-of-care measurement. (Specificity)",null,"From enrolment to initial CT scan up until 7 day assessment",[14,16,18,20,23,27,29],{"measure":15,"description":11,"timeFrame":12},"Proportion of participants with ICH on hospital-based brain CT who are correctly identified as positive based on GFAP point-of-care measurement.",{"measure":17,"description":11,"timeFrame":12},"Proportion of participants with a positive GFAP point-of-care measurement who are confirmed to have ICH on hospital-based brain CT.",{"measure":19,"description":11,"timeFrame":12},"Proportion of participants with a negative GFAP point-of-care measurement who are confirmed to not have an ICH on hospital-based brain CT.",{"measure":21,"description":11,"timeFrame":22},"Feasibility of recruitment, assessed by the proportion of enrolled participants over the number of stroke calls in the participating networks during the study period.","From enrollment to end of the study.",{"measure":24,"description":25,"timeFrame":26},"Feasibility of protocol delivery, assessed by the proportion of participants for whom all required study assessments in the ambulance were completed among those in whom assessments were initiated.","Study assesments include: participant screening, GFAP testing with the point-of-care device, and data entry","From enrolment to transfer to hospital at day 1",{"measure":28,"description":11,"timeFrame":26},"Feasibility of GFAP testing in the prehospital setting, defined as the proportion of enrolled participants in whom GFAP testing was successfully completed using the point-of-care device in the ambulance.",{"measure":30,"description":11,"timeFrame":26},"Correlation of GFAP measurement by the point-of-care device against a laboratory assay.",[32],{"measure":33,"description":34,"timeFrame":12},"Sensitivity, specificity, positive predictive value, and negative predictive value for identifying ICH using a (+) GFAP combined with a (-) D-dimer result on the point-of-care device, compared with hospital-based brain CT.","Exploratory outcome",{"allocation":11,"interventionModel":11,"interventionModelDescription":11,"primaryPurpose":11,"observationalModel":6,"timePerspective":36,"maskingInfo":11},"PROSPECTIVE","Patients with suspected acute stroke presenting to ambulance services",[39],{"type":40,"name":41,"description":42,"armGroupLabels":11,"otherNames":11},"DIAGNOSTIC_TEST","LVOne","LVOne is an in vitro diagnostic rapid lateral flow chromatographic immunoassay kit",[44,49],{"name":45,"role":46,"phone":47,"phoneExt":11,"email":48},"Craig Anderson, MD","CONTACT","+61 4039448107","canderson@georgeinstitute.org.au",{"name":50,"role":46,"phone":11,"phoneExt":11,"email":51},"Cheryl Carcel, MD","ccarcel@georgeinsitute.org.au",[53,73,82,91],{"facility":54,"status":11,"city":55,"state":56,"zip":11,"country":57,"countryCode":58,"cosmosGeoPoint":59,"geoPoint":64,"contacts":65},"Liverpool Hospital","Sydney","New South Wales","Australia","AU",{"type":60,"coordinates":61},"Point",[62,63],151.20732,-33.86785,{"lat":63,"lon":62},[66,70],{"name":67,"role":46,"phone":68,"phoneExt":11,"email":69},"Cheryl Carcel","+61 2 8052 4508","ccarcel@georgeinstitute.org.au",{"name":71,"role":72,"phone":11,"phoneExt":11,"email":11},"Dennis Cordato","PRINCIPAL_INVESTIGATOR",{"facility":74,"status":11,"city":55,"state":56,"zip":11,"country":57,"countryCode":58,"cosmosGeoPoint":75,"geoPoint":77,"contacts":78},"Nepean Hospital",{"type":60,"coordinates":76},[62,63],{"lat":63,"lon":62},[79,80],{"name":67,"role":46,"phone":68,"phoneExt":11,"email":69},{"name":81,"role":72,"phone":11,"phoneExt":11,"email":11},"Sameen Haque",{"facility":83,"status":11,"city":55,"state":56,"zip":11,"country":57,"countryCode":58,"cosmosGeoPoint":84,"geoPoint":86,"contacts":87},"New South Wales Ambulance",{"type":60,"coordinates":85},[62,63],{"lat":63,"lon":62},[88,89],{"name":67,"role":46,"phone":68,"phoneExt":11,"email":69},{"name":90,"role":72,"phone":11,"phoneExt":11,"email":11},"David Patterson",{"facility":92,"status":11,"city":55,"state":56,"zip":11,"country":57,"countryCode":58,"cosmosGeoPoint":93,"geoPoint":95,"contacts":96},"Royal North Shore Hospital",{"type":60,"coordinates":94},[62,63],{"lat":63,"lon":62},[97,98],{"name":67,"role":46,"phone":68,"phoneExt":11,"email":69},{"name":99,"role":72,"phone":11,"phoneExt":11,"email":11},"Christopher Partyka",{"type":101,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100610725",false,"NCT07231315","INTERACT4 Expansion - Validation Study","INTEnsive Ambulance-delivered Blood Pressure Reduction in Biomarker-identified Hyper-ACute Intracerebral Haemorrhage Trial - Validation Study","INTERACT4 Exp","Inclusion Criteria:\n\n1. Adults (age ≥18 years);\n2. Acute syndrome that is due to presumed acute stroke, defined as FAST (Face, Arm, Speech, Time) scores of ≥2 with an arm motor deficit;\n3. Time ≤3 hours from last seen well;\n4. Systolic BP (SBP) ≥150mmHg.\n\nExclusion Criteria:\n\n1. Participants in coma (no response to tactile\u002Fverbal stimulation); or\u002Fand do not respond to \"P\" or \"U\" on the alert\u002Fverbal\u002Fpainful\u002Funresponsive (APVU) responsiveness scale;\n2. Severe known co-morbid disease (e.g. cancer, chronic airflow disease, severe dementia, severe heart failure, pre-existing disability \\[needing help\\]);\n3. Known history of epilepsy or seizure at onset;\n4. Recent head injury (where there is potential for another type of intracranial haemorrhage or head trauma);\n5. Hypoglycaemia (glucose\\\u003C4.0 mmol\u002FL) as measured in the ambulance.","ALL","18 Years",{"count":112,"type":113},465,"ESTIMATED","OBSERVATIONAL","As an investigator-initiated and conducted, multi-centre, open-label, single-arm prospective observational trial, INTERACT4 Expansion aims to evaluate the diagnostic accuracy of GFAP measured using a point-of-care device, for identifying ICH in participants presenting with acute stroke-like symptoms in the pre-hospital setting compared with imaging-confirmed ICH.",[117],"Intracerebral Hemorrhage","NOT_YET_RECRUITING","2025-11-17",{"date":121,"type":122},"2025-11-19","ACTUAL",{"date":124,"type":113},"2026-02-01",{"date":126,"type":113},"2027-06-01",{"name":5,"class":6},4]