[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100400125":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":24,"locations":31,"responsibleParty":52,"collaborators":18,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":60,"eligibilityCriteria":61,"healthyVolunteers":56,"sex":62,"minAge":63,"maxAge":64,"enrollmentInfo":65,"targetDuration":18,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":77,"overallStatus":34,"whyStopped":18,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"Medical University Innsbruck","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Interventional","EXPERIMENTAL","Subjects will receive reinstallation of CSF intravenously.",[13],"Other: intravenous reinstallation of cerebrospinal fluid",{"label":15,"type":16,"description":17,"interventionNames":18},"Observational","NO_INTERVENTION","Subjects will not receive study intervention; CSF will be sampled and analyzed in comparison to the Interventional arm,",null,[20],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":18},"intravenous reinstallation of cerebrospinal fluid","10ml of CSF will be taken under sterile conditions from the external ventricular drain and immediately administered intravenously.",[9],[25],{"name":26,"role":27,"phone":28,"phoneExt":29,"email":30},"Christian F Freyschlag, MD","CONTACT","+4350504","27452","christian.freyschlag@i-med.ac.at",[32],{"facility":33,"status":34,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"Medical University of Innsbruck","RECRUITING","Innsbruck","Tyrol","6020","Austria","AT",{"type":41,"coordinates":42},"Point",[43,44],11.39454,47.26266,{"lat":44,"lon":43},[47,49],{"name":48,"role":27,"phone":28,"phoneExt":29,"email":30},"Christian F. Freyschlag, MD",{"name":50,"role":27,"phone":28,"phoneExt":29,"email":51},"Johannes Kerschbaumer, MD","johannes.kerschbaumer@tirol-kliniken.at",{"type":53,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100400125","prevention-of-vasospasm-in-sah-through-csf-treatment-100400125",false,"NCT04490161","Prevention of Vasospasm in SAH Through CSF Treatment","Prevention of Cerebral Vasospasm Following Aneurysmal Subarachnoid Hemorrhage Through Treatment With Intravenous Autologous Cerebrospinal Fluid - a Pilot Trial.","PREVAIL","Inclusion Criteria:\n\nAge: \\>18, \\\u003C90\n\n* SAH HH 3 - 5\n* Cerebral saccular Aneurysm\n* Digital subtraction angiography prior to aneurysm repair\n* Aneurysm repair within 72h\n* Modified Fisher Grade 3+4\n* Presence of aneurysm needing treatment (clipping or coiling)\n* Treatment within 24 hours of symptom onset\n* External ventricular drain (clinical need)\n\nExclusion Criteria:\n\n* Non-aneurysmal SAH\n\n  * SAH HH\\\u003C3\n  * Extensive intraventricular haemorrhage (unable to obtain CSF without massive aspiration of clotted blood)\n  * Contraindication for digital subtraction angiography\n  * Aneurysm repair \\>72h after rupture\n  * Signs of radiographic vasospasm upon diagnosis\n  * Presence of systemic or CSF infection\n  * Contraindication for oral Nimodipin\n  * Pregnancy","ALL","18 Years","90 Years",{"count":66,"type":67},20,"ESTIMATED","INTERVENTIONAL",[70],"NA","The pathophysiological mechanisms of aneurysmal subarachnoid haemorrhage (aSAH) involve early brain injury (EBI) and delayed cerebral ischemia (DCI).\n\nSeveral mechanisms contribute to EBI pathogenesis, including cell death, inflammatory response, oxidative stress, excitotoxicity, microcirculatory dysfunction, microthrombosis and cortical spreading depolarization. All are suggested to be linked due to common pathogenic pathways and direct interaction.\n\nDespite advances in research of diagnostics and treatment strategies, brain injury remains the major cause of death and disability in SAH patients. There is no sufficient treatment of SAH and its devastating consequences known so far. Developing and improving diagnostic methods to monitor SAH patients and to evaluate efficacy of treatment strategies are essential in SAH research. These include neuroimaging, biomarkers, and other parameters such as invasive multimodal neuromonitoring and intraoperative electrophysiological monitoring.\n\nCerebral vasospasm (CV) - mostly responsible for DCI - can be depicted on angiograms. Altogether, tremendous efforts have been taken to conquer the occurrence and sustainability of CV. The mortality of patients suffering aSAH rises up to 50% if the patients' condition is critical (Hunt\\&Hess (HH) Grade 5, WFNS Grade 5, modified Fisher Grade 4).\n\nReports of beneficial outcome in patients with pre-existing CSF shunting have been published. The hypothesis of early CSF reapplication to the bloodstream, in order to prevent CV seems to be positively approved by the mentioned reports. Nevertheless, no data could be found on the mechanisms of action in this phenomenon.\n\nTo confirm the presence of interaction of the mechanisms of EBI and evaluate the application of cerebrospinal fluid (CSF), a pilot clinical trial was planned. Due to the lack of validated animal models for aSAH it is necessary to perform the trial first-in-human. A pilot (proof of concept) trial - is done through inclusion of 10 patients with severe aSAH (≥HH4). According to clinical guidelines, these patients receive external ventricular drainages in order to drain CSF and lower intracranial pressure. An interim analysis of data will be performed after inclusion and treatment of 5 patients. Blood-\u002FCSF-sampling for further analysis will be collected before, during and after treatment according to the study protocol.",[73,74,75,76],"Subarachnoid Hemorrhage","Subarachnoid Hemorrhage, Aneurysmal","Vasospasm, Cerebral","Aneurysmal Subarachnoid Hemorrhage",[78,79,80,81,82,83],"EVD","Aneurysm","SAH","Subarachnoid hemorrhage","cerebral vasospasm","cerebrospinal fluid","2024-11-25",{"date":86,"type":87},"2024-11-27","ACTUAL",{"date":89,"type":87},"2020-01-01",{"date":91,"type":67},"2025-02-01",{"name":5,"class":6},1]