[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100559480":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":27,"locations":35,"responsibleParty":110,"collaborators":114,"id":126,"slug":127,"hasResults":128,"nctId":129,"briefTitle":130,"officialTitle":130,"acronym":131,"eligibilityCriteria":132,"healthyVolunteers":128,"sex":133,"minAge":134,"maxAge":135,"enrollmentInfo":136,"targetDuration":10,"studyType":139,"phases":10,"briefSummary":140,"conditions":141,"keywords":10,"overallStatus":38,"whyStopped":10,"lastUpdateSubmitDate":143,"lastUpdatePostDateStruct":144,"startDateStruct":147,"completionDateStruct":149,"leadSponsor":151,"locationsCount":152},{"fullName":5,"class":6},"University of Helsinki","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"OHCA patients",null,"OHCA patients, randomized to STEPCARE Trial. The patients are recruiten to this substudy in selected centers with access to the Brainstatus device for recording of cEEG.\n\nAdult patients who remain comatose after sustained ROSC after OHCA are eligible to the STEPCARE Trial. Exclusion criteria are pregnancy, previous randomization to STEPCARE, trauma or hemorrhage as reasons for arrest, suspected or confirmed intracranial hemorrhage, and specifically for this study allergy to adhesive material and injured skin in the frontal-temporal area, that prevents adhesion of the Brainstatus electrode.",[13],"Diagnostic Test: C-Trend Index",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DIAGNOSTIC_TEST","C-Trend Index","C-trend-Index is collected blinded from the patients using Brainstatus device. The device shows and collects also cEEG. These are analyzed retrospectively after all study patients have their 6-month follow-up data collected. The intervention does not affect clinical management or decision-making.",[9],[21],"visual assessment of cEEG",[23],{"name":24,"affiliation":25,"role":26},"Jukka Kortelainen, MD, PhD","University of Oulu","STUDY_DIRECTOR",[28,33],{"name":29,"role":30,"phone":31,"phoneExt":10,"email":32},"Johanna Hästbacka, a\u002Fc professor","CONTACT","+358415058360","johanna.hastbacka@tuni.fi",{"name":24,"role":30,"phone":10,"phoneExt":10,"email":34},"jukka.kortelainen@oulu.fi",[36,60,72,88],{"facility":37,"status":38,"city":39,"state":10,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Helsinki University Hospital","RECRUITING","Helsinki","00290","Finland","FI",{"type":44,"coordinates":45},"Point",[46,47],24.93545,60.16952,{"lat":47,"lon":46},[50,54,57],{"name":51,"role":30,"phone":52,"phoneExt":10,"email":53},"Marjaana Tiainen, A\u002FC professor","4711","marjaana.tiainen@hus.fi",{"name":55,"role":30,"phone":52,"phoneExt":10,"email":56},"Markus Skrifvars, professor","markus.skrifvars@hus.fi",{"name":58,"role":59,"phone":10,"phoneExt":10,"email":10},"Ville Niemelä","SUB_INVESTIGATOR",{"facility":61,"status":38,"city":62,"state":10,"zip":10,"country":41,"countryCode":42,"cosmosGeoPoint":63,"geoPoint":67,"contacts":68},"Kuopio University Hospital","Kuopio",{"type":44,"coordinates":64},[65,66],27.67703,62.89238,{"lat":66,"lon":65},[69],{"name":70,"role":30,"phone":10,"phoneExt":10,"email":71},"Matti Reinikainen, professor","matti.reinikainen@pshyvinvointialue.fi",{"facility":73,"status":38,"city":74,"state":10,"zip":10,"country":41,"countryCode":42,"cosmosGeoPoint":75,"geoPoint":79,"contacts":80},"Tampere University Hospital","Tampere",{"type":44,"coordinates":76},[77,78],23.78712,61.49911,{"lat":78,"lon":77},[81,83,86],{"name":82,"role":30,"phone":31,"phoneExt":10,"email":32},"Johanna Hästbacka, A\u002FC prof",{"name":84,"role":85,"phone":10,"phoneExt":10,"email":10},"Joonas Tirkkonen","PRINCIPAL_INVESTIGATOR",{"name":87,"role":59,"phone":10,"phoneExt":10,"email":10},"Emilia Kortesuo",{"facility":89,"status":38,"city":90,"state":10,"zip":10,"country":91,"countryCode":92,"cosmosGeoPoint":93,"geoPoint":97,"contacts":98},"Skane University Hospital","Lund","Sweden","SE",{"type":44,"coordinates":94},[95,96],13.19321,55.70584,{"lat":96,"lon":95},[99,103,106,108],{"name":100,"role":30,"phone":101,"phoneExt":10,"email":102},"Marion Moseby-Knappe, MD, PhD","+4646172443","marion.moseby_knappe@med.lu.se",{"name":104,"role":30,"phone":10,"phoneExt":10,"email":105},"Erik Westhall, A\u002FC professor","erik.westhall@med.lu.se",{"name":107,"role":59,"phone":10,"phoneExt":10,"email":10},"Marjolein Admiraal",{"name":109,"role":59,"phone":10,"phoneExt":10,"email":10},"Anna Lybäck",{"type":85,"investigatorFullName":111,"investigatorTitle":112,"investigatorAffiliation":113,"oldNameTitle":10,"oldOrganization":10},"Johanna Hastbacka","associate professor","Tampere University",[115,116,117,119,120,121,123,125],{"name":25,"class":6},{"name":89,"class":6},{"name":118,"class":6},"Helsinki University Central Hospital",{"name":61,"class":6},{"name":113,"class":6},{"name":122,"class":6},"Charite University, Berlin, Germany",{"name":124,"class":6},"Oslo University Hospital",{"name":73,"class":6},"100559480","accuracy-of-eeg-slow-wave-activity-in-predicting-favourable-outcome-in-patients-with-hypoxic-brain-injury---a-substudy-of-stepcare-trial-100559480",false,"NCT06564675","Accuracy of EEG Slow Wave Activity in Predicting Favourable Outcome in Patients With Hypoxic Brain Injury - A Substudy of STEPCARE Trial","PROPEASTEPCARE","Inclusion Criteria:\n\n* Age 18 years or older\n* OHCA, with sustained ROSC\n* Unconscious after ROSC\n* No limitations to full life support\n* Randomized to STEPCARE Trial in a participating center with Brainstatus device available\n\nExclusion Criteria:\n\n* age \\\u003C18\n* Previously randomized to STEPCARE\n* Trauma or hemorrhage as the reasons for arrest\n* Suspected or confirmed intracerebral hemorrhage\n* Allergy to adhesive material\n* Damaged skin at the frontal-temporal are preventing electrode attachment","ALL","18 Years","110 Years",{"count":137,"type":138},300,"ESTIMATED","OBSERVATIONAL","This is an observational substudy embedded in the STEPCARE Trial. The study involves EEG analysis, covered by the ethics approval of STEPCARE Trial. The investigators aim to compare the accuracy of a continuously measured algorithm-based EEG index, C-Trend Index, with retrospective visual analysis of continuous EEG in predicting favorable functional outcome in adult patients treated in intensive care units after out-of-hospital cardiac arrest. The primary hypothesis is that the accuracy of C-Trend Index has at least 10% better accuracy in predicting favorable outcome than the visual analysis of cEEG, when assessed early, 9-12 hours after return of spontaneous circulation (ROSC).",[142],"Out-Of-Hospital Cardiac Arrest","2024-08-26",{"date":145,"type":146},"2024-08-28","ACTUAL",{"date":148,"type":146},"2023-08-01",{"date":150,"type":138},"2027-03-03",{"name":5,"class":6},4]