[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100602906":3},{"organization":4,"armGroups":7,"interventions":7,"overallOfficials":8,"centralContacts":13,"locations":22,"responsibleParty":63,"collaborators":7,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":71,"acronym":7,"eligibilityCriteria":72,"healthyVolunteers":69,"sex":73,"minAge":74,"maxAge":7,"enrollmentInfo":75,"targetDuration":7,"studyType":78,"phases":7,"briefSummary":79,"conditions":80,"keywords":7,"overallStatus":25,"whyStopped":7,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"University of Debrecen","OTHER",null,[9],{"name":10,"affiliation":11,"role":12},"Csilla Molnár, MD PhD Full Professor","University of Debrecen, Faculty of Medicine, Department of Anaesthesiology and Intensive Care","PRINCIPAL_INVESTIGATOR",[14,18],{"name":10,"role":15,"phone":16,"phoneExt":7,"email":17},"CONTACT","+36302998097","csmolnar@med.unideb.hu",{"name":19,"role":15,"phone":20,"phoneExt":7,"email":21},"Dorottya Szántó, MD","+36309990718","szanto.dorottya@med.unideb.hu",[23],{"facility":24,"status":25,"city":26,"state":7,"zip":27,"country":28,"countryCode":29,"cosmosGeoPoint":30,"geoPoint":35,"contacts":36},"University of Debrecen, Department of Anesthesiology and Intensive Care","RECRUITING","Debrecen","4032","Hungary","HU",{"type":31,"coordinates":32},"Point",[33,34],21.62444,47.53167,{"lat":34,"lon":33},[37,38,40,41,43,45,47,49,51,53,55,57,59,61],{"name":10,"role":15,"phone":16,"phoneExt":7,"email":17},{"name":39,"role":15,"phone":20,"phoneExt":7,"email":21},"Dorottya MSzántó, MD",{"name":10,"role":12,"phone":7,"phoneExt":7,"email":7},{"name":19,"role":42,"phone":7,"phoneExt":7,"email":7},"SUB_INVESTIGATOR",{"name":44,"role":42,"phone":7,"phoneExt":7,"email":7},"Nikolett Noémi Kóti, MD",{"name":46,"role":42,"phone":7,"phoneExt":7,"email":7},"Nóra Czakó, MD",{"name":48,"role":42,"phone":7,"phoneExt":7,"email":7},"Péter Síró, MD PhD",{"name":50,"role":42,"phone":7,"phoneExt":7,"email":7},"Béla Fülesdi, MD PhD Full Professor DSc",{"name":52,"role":42,"phone":7,"phoneExt":7,"email":7},"Béla Nagy, MD PhD Associate Professor",{"name":54,"role":42,"phone":7,"phoneExt":7,"email":7},"Zsuzsa Bagoly, MD PhD Associate Professor",{"name":56,"role":42,"phone":7,"phoneExt":7,"email":7},"Ferenc Bodnár, MD",{"name":58,"role":42,"phone":7,"phoneExt":7,"email":7},"Judit Gál, MD PhD",{"name":60,"role":42,"phone":7,"phoneExt":7,"email":7},"Zsuzsa Jakab, MD",{"name":62,"role":42,"phone":7,"phoneExt":7,"email":7},"Anna Eszter Abuczki, medical student",{"type":64,"investigatorFullName":65,"investigatorTitle":66,"investigatorAffiliation":5,"oldNameTitle":7,"oldOrganization":7},"SPONSOR_INVESTIGATOR","Tamas Vegh, MD","MD PhD","100602906","investigation-of-the-role-of-inflammatory-markers-in-the-early-detection-of-cerebral-vasospasm-delayed-cerebral-ischemia-and-meningitis-associated-with-external-cerebrospinal-fluid-drainage-after-non-traumatic-subarachnoid-hemorrhage---a-prospective-case-control-study-100602906",false,"NCT07129603","Investigation of the Role of Inflammatory Markers in the Early Detection of Cerebral Vasospasm, Delayed Cerebral Ischemia, and Meningitis Associated With External Cerebrospinal Fluid Drainage After Non-Traumatic Subarachnoid Hemorrhage - A Prospective Case-Control Study","Inclusion Criteria:\n\n* Adults (≥18 years).\n* Angiography-identifiable non-traumatic SAH (regardless of source).\n* Requires lumbar or ventricular drain as part of treatment.\n\nExclusion Criteria:\n\n* Traumatic SAH.\n* Patient\u002Flegal representative does not consent.\n* Meningitis within 6 months prior to ictus.\n* Immunosuppressed state (disease or medications affecting WBC number\u002Ffunction).","ALL","18 Years",{"count":76,"type":77},100,"ESTIMATED","OBSERVATIONAL","Background Non-traumatic subarachnoid haemorrhage (SAH) is frequently complicated by delayed cerebral ischaemia (DCI) and by ventriculitis\u002Fmeningitis when external CSF drains are used; bedside TCCD has limited accuracy for vasospasm detection, creating a need for early biomarkers.\n\nObjective To assess the predictive and diagnostic performance of IL-6, IL-1β, TNFα, procalcitonin (PCT), C-reactive protein (CRP) and adrenomedullin (ADM) measured in CSF and serum for vasospasm, DCI, and drain-associated ventriculitis\u002Fmeningitis after SAH; to test whether combining biomarkers improves accuracy versus routine parameters; and to explore associations with admission and day-14 serum 25-hydroxy-vitamin D.\n\nMethods Prospective case-control study at the University of Debrecen (planned n≈100; enrolment 01-Nov-2024-31-Dec-2029). Adults with angiography-verified SAH requiring lumbar\u002Fventricular drainage are included; traumatic SAH, prior 6-month meningitis, and immunosuppression are excluded. TCCD is performed daily for 14 days; suspected vasospasm is defined by mean flow velocity \\>120 cm\u002Fs, severe by \\>200 cm\u002Fs, with monitoring extended to day 21 if severe. Sampling: daily CSF IL-6\u002FPCT\u002FCRP until drain removal; IL-1β\u002FTNFα\u002FADM at 0-2, 3-5, 6-8, 9-11, 12-14 days and at meningitis detection; serum 25-OH-D on drain insertion day and day 14. Outcomes at days 30\u002F90\u002F180: mortality, GOSE, Barthel, Karnofsky, mRS. Statistics: normality testing; t-test or non-parametric equivalents; χ² with Yates' correction; Bonferroni for multiplicity; ROC analysis for diagnostic\u002Fpredictive performance.\n\nEndpoints DCI: new unexplained CT ischaemia or a new unexplained neurological deficit \\>1 h. Drain-associated infection: infectologist-adjudicated ventriculitis\u002Fmeningitis. Vasospasm: TCCD-suggested or DSA-confirmed.\n\nExpected impact An accessible CSF\u002Fserum biomarker panel may enable earlier risk stratification and treatment for vasospasm, DCI, and drain-associated infections, and inform future randomized trials of vitamin-D supplementation in SAH.",[81],"Subarachnoid Haemorrhagic Stroke","2025-08-11",{"date":84,"type":85},"2025-08-19","ACTUAL",{"date":87,"type":85},"2025-08-01",{"date":89,"type":77},"2029-12-31",{"name":65,"class":6},1]