[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100639121":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":32,"locations":43,"responsibleParty":101,"collaborators":26,"id":103,"slug":104,"hasResults":105,"nctId":106,"briefTitle":107,"officialTitle":107,"acronym":108,"eligibilityCriteria":109,"healthyVolunteers":105,"sex":110,"minAge":111,"maxAge":26,"enrollmentInfo":112,"targetDuration":26,"studyType":115,"phases":116,"briefSummary":118,"conditions":119,"keywords":124,"overallStatus":132,"whyStopped":26,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":142},{"fullName":5,"class":6},"University Hospital, Angers","OTHER_GOV",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Direct clamping","EXPERIMENTAL","From Day 4 after external ventricular drain insertion, weanability criteria are screened daily: absence of intracranial hypertension for the previous 24 hours, minimal sedation, and external ventricular drainage output below predefined thresholds (\\\u003C200 ml\u002F24h with a 3-hour intracranial pressure tolerance test confirming intracranial pressure does not rise by more than 5 mmHg at 3 hours; or \\\u003C160 ml\u002F24h without test). When criteria are met, the external ventricular drain is directly clamped for 48 hours, under continuous ICP monitoring.",[13],"Procedure: Direct clamping of external ventricular drain",{"label":15,"type":16,"description":17,"interventionNames":18},"Progressive (gradual) weaning","ACTIVE_COMPARATOR","When the patient's condition improves (neurological improvement for at least 48 hours, no intracranial hypertension), the external ventricular drain level is progressively raised by 5 mmHg per day, provided no neurological deterioration or intracranial hypertension occurs (otherwise the external ventricular drain level is lowered to the previous one). When the external ventricular drain level reaches ≥20 mmHg and is tolerated for 24 hours, the external ventricular drain is clamped for 48 hours, under continuous intracranial pressure monitoring.",[19],"Genetic: Progressive (gradual) weaning of external ventricular drain",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","Direct clamping of external ventricular drain","Daily screening from Day 4 of standardized weanability criteria (no intracranial hypertension for 24h, minimal sedation, external ventricular drainage output \\\u003C200 ml\u002F24h with a 3-hour intracranial pressure tolerance test or \\\u003C160 ml\u002F24h without test). When criteria are met, the external ventricular drain is directly clamped. The clamping period lasts 48 hours under continuous intracranial pressure monitoring, with a control CT scan performed before external ventricular drain removal. The external ventricular drain is removed in the absence of neurological deterioration, intracranial hypertension, cerebrospinal fluid leak, or ventricular enlargement.",[9],null,{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":26},"GENETIC","Progressive (gradual) weaning of external ventricular drain","When the patient's clinical condition improves (neurological improvement for ≥48 hours, no intracranial hypertension), the external ventricular drain level is raised by 5 mmHg per day. If neurological deterioration or intracranial hypertension occurs, the external ventricular drain level is lowered to the previous one. When the external ventricular drain level reaches ≥20 mmHg and is tolerated for 24 hours, the external ventricular drain is clamped for 48 hours under continuous intracranial pressure monitoring, with a control CT scan performed before external ventricular drain removal. Theexternal ventricular drain is removed in the absence of neurological deterioration, intracranial hypertension, cerebrospinal fluid leak, or ventricular enlargement.",[15],[33,39],{"name":34,"role":35,"phone":36,"phoneExt":37,"email":38},"Maeva CAMPFORT, MD","CONTACT","241353635","+33","maeva.campfort@chu-angers.fr",{"name":40,"role":35,"phone":41,"phoneExt":37,"email":42},"Promotion Interne","241353637","drci-promotion-interne@chu-angers.fr",[44,57,68,79,90],{"facility":45,"status":26,"city":46,"state":26,"zip":26,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"University Hospital Angers","Angers","France","FR",{"type":50,"coordinates":51},"Point",[52,53],-0.55202,47.47156,{"lat":53,"lon":52},[56],{"name":34,"role":35,"phone":26,"phoneExt":26,"email":26},{"facility":58,"status":26,"city":59,"state":26,"zip":26,"country":47,"countryCode":48,"cosmosGeoPoint":60,"geoPoint":64,"contacts":65},"University Hospital Brest","Brest",{"type":50,"coordinates":61},[62,63],-4.48628,48.39029,{"lat":63,"lon":62},[66],{"name":67,"role":35,"phone":26,"phoneExt":26,"email":26},"Olivier LANGERON, MD PhD",{"facility":69,"status":26,"city":70,"state":26,"zip":26,"country":47,"countryCode":48,"cosmosGeoPoint":71,"geoPoint":75,"contacts":76},"University Hospital Nantes","Nantes",{"type":50,"coordinates":72},[73,74],-1.55336,47.21725,{"lat":74,"lon":73},[77],{"name":78,"role":35,"phone":26,"phoneExt":26,"email":26},"Antoine ROQUILLY, MD PhD",{"facility":80,"status":26,"city":81,"state":26,"zip":26,"country":47,"countryCode":48,"cosmosGeoPoint":82,"geoPoint":86,"contacts":87},"University Hospital Poitiers","Poitiers",{"type":50,"coordinates":83},[84,85],0.34348,46.58261,{"lat":85,"lon":84},[88],{"name":89,"role":35,"phone":26,"phoneExt":26,"email":26},"Claire DAHYOT-FIZELIER, MD PhD",{"facility":91,"status":26,"city":92,"state":26,"zip":26,"country":47,"countryCode":48,"cosmosGeoPoint":93,"geoPoint":97,"contacts":98},"University Hospital Rennes","Rennes",{"type":50,"coordinates":94},[95,96],-1.67431,48.11109,{"lat":96,"lon":95},[99],{"name":100,"role":35,"phone":26,"phoneExt":26,"email":26},"Yoann LAUNEY, MD PhD",{"type":102,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100639121","strategies-for-weaning-from-external-ventricular-drainage-100639121",false,"NCT07630051","Strategies for Weaning From External Ventricular Drainage","SEVDVE2","Inclusion Criteria:\n\n* Adult patient (≥18 years)\n* Admitted to critical care for non-traumatic subarachnoid hemorrhage for less than 3 days\n* First external ventricular drain inserted within the last 3 days for hydrocephalus and\u002For intracranial hypertension\n* Patient consent, or consent from a relative, or inclusion under emergency inclusion procedure\n* Patient affiliated to or beneficiary of a social security scheme\n\nExclusion Criteria:\n\n* Moribund patient or patient with established treatment limitation\u002Fwithdrawal decisions\n* Patient with a pre-existing ventriculoperitoneal or ventriculoatrial shunt\n* Patient with chronic hydrocephalus\n* Pregnant, lactating, or parturient woman\n* Person deprived of liberty by judicial or administrative decision\n* Person under involuntary psychiatric care\n* Person under a legal protection measure\n* Concurrent participation in another study involving external ventricular drainage management","ALL","18 Years",{"count":113,"type":114},170,"ESTIMATED","INTERVENTIONAL",[117],"NA","External ventricular drainage is frequently used in neurocritical care, particularly in patients admitted for non-traumatic subarachnoid hemorrhage who develop hydrocephalus and\u002For intracranial hypertension. While external ventricular drainage is often initially lifesaving, its prolonged maintenance is associated with complications, especially infections and prolonged hospital length of stay. There is currently no consensus on the optimal weaning strategy. Two approaches are used in routine practice: direct clamping (the external ventricular drain is closed as soon as weanability criteria are met) and gradual weaning (the external ventricular drain level is progressively raised before final clamping). No randomized controlled trial has yet demonstrated the superiority of one strategy over the other in patients with non-traumatic subarachnoid hemorrhage.\n\nThe investigators hypothesize that a direct clamping strategy, combined with daily screening of standardized weanability criteria, will reduce the duration of external ventricular drain maintenance compared with the conventional gradual weaning strategy. SEVDVE-2 is a multicenter, randomized, controlled, parallel-group, single-blind superiority trial that will compare these two weaning strategies in 170 adult patients admitted to critical care for non-traumatic subarachnoid hemorrhage with a first external ventricular drain inserted within the previous 3 days. Patients will be randomized 1:1, stratified on the presence of an intraventricular hematoma. The primary outcome is the number of external ventricular drain-free days alive at Day 28.",[120,121,122,123],"Subarachnoid Hemorrhage","Hydrocephalus","Intracranial Hypertension","External Ventricular Drainage",[125,120,126,127,128,129,130,131],"External Ventricular Drain","Weaning; Hydrocephalus","Intracranial Pressure","Neurocritical Care","Direct Clamping","Gradual Weaning","Randomized Controlled Trial","NOT_YET_RECRUITING","2026-06-01",{"date":135,"type":136},"2026-06-05","ACTUAL",{"date":138,"type":114},"2026-07-01",{"date":140,"type":114},"2031-10-01",{"name":5,"class":6},5]