[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100643971":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":26,"locations":37,"responsibleParty":54,"collaborators":31,"id":57,"slug":31,"hasResults":58,"nctId":59,"briefTitle":9,"officialTitle":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":58,"sex":63,"minAge":64,"maxAge":31,"enrollmentInfo":65,"targetDuration":31,"studyType":68,"phases":69,"briefSummary":72,"conditions":73,"keywords":75,"overallStatus":79,"whyStopped":31,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"Massachusetts General Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Ventricular mTOR Inhibition to Prevent Hydrocephalus After Brain Hemorrhage","EXPERIMENTAL","The investigators will conduct a prospective, single-center, phase Ib\u002FIIa, biomarker-rich translational pilot study evaluating intraventricular mTOR inhibition in adults with severe aneurysmal subarachnoid hemorrhage (aSAH) who require external ventricular drain (EVD) placement as part of routine neurocritical care management. The central objective of the study is to determine whether early modulation of ventricular immune-secretory signaling is feasible, biologically active, and capable of altering inflammatory CSF physiology and ventricular remodeling following hemorrhage.",[13],"Drug: Sirolimus (Rapamune®)",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Sirolimus (Rapamune®)","Ventricular delivery",[9],[21],"Rapamycin",[23],{"name":24,"affiliation":5,"role":25},"Kristopher Kahle, MD, PhD","PRINCIPAL_INVESTIGATOR",[27,33],{"name":28,"role":29,"phone":30,"phoneExt":31,"email":32},"Kristopher Kahle, M.D., Ph.D.","CONTACT","14143057506",null,"kahle.kristopher@mgh.harvard.edu",{"name":34,"role":29,"phone":35,"phoneExt":31,"email":36},"Carla Fortes, BA","16175489679","CFORTES@MGH.HARVARD.EDU",[38],{"facility":39,"status":31,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Massachusetts General Hospital Lunder 4 OR for adult surgeries","Boston","Massachusetts","02114","United States","US",{"type":46,"coordinates":47},"Point",[48,49],-71.05977,42.35843,{"lat":49,"lon":48},[52,53],{"name":34,"role":29,"phone":35,"phoneExt":31,"email":36},{"name":24,"role":25,"phone":31,"phoneExt":31,"email":31},{"type":25,"investigatorFullName":55,"investigatorTitle":56,"investigatorAffiliation":5,"oldNameTitle":31,"oldOrganization":31},"Kristopher Kahle","Nicholas T. Zervas Endowed Chair and Associate Professor of Neurosurgery","100643971",false,"NCT07662174","VENTURE-PHH: Ventricular mTOR Inhibition to Prevent Hydrocephalus After Brain Hemorrhage","VENTURE-PHH","Inclusion Criteria:\n\n* Age ≥18 years\n* Diagnosis of aneurysmal subarachnoid hemorrhage (aSAH)\n* Hunt Hess grade IV to V\n* Radiographic evidence of intraventricular hemorrhage (IVH)\n* Clinically indicated EVD placement as part of standard neurocritical care\n* Ability to enroll during the acute post-hemorrhagic inflammatory period, ideally within 24 hours of EVD placement\n\nExclusion Criteria:\n\n* Pre-existing ventriculoperitoneal shunt dependence\n* Severe baseline immunosuppression\n* Uncontrolled systemic infection unrelated to hemorrhage\n* Pregnancy\n* Anticipated withdrawal of life-sustaining therapy within 24 hours\n* Inability to safely receive investigational ventricular therapy","ALL","18 Years",{"count":66,"type":67},15,"ESTIMATED","INTERVENTIONAL",[70,71],"PHASE1","PHASE2","Hydrocephalus is a serious condition in which fluid builds up inside the brain, often requiring lifelong surgical placement of a shunt to drain excess cerebrospinal fluid (CSF). One of the most common causes of hydrocephalus is bleeding into the brain's fluid spaces after aneurysm rupture, prematurity, or infection. Currently, no medication exists to prevent hydrocephalus from developing after these injuries. The investigators' recent research suggests that hydrocephalus may result not only from blocked fluid pathways but also from harmful inflammation within the brain's ventricular system. The investigators discovered that inflammation activates the choroid plexus, the tissue that produces CSF, causing excessive CSF production and inflammatory injury to the ventricular lining and surrounding brain tissue. The investigators also identified inflammatory biomarkers and extracellular vesicles in human CSF that may enable real-time monitoring of these disease processes.\n\nIn this project, the investigators will perform a first-in-human pilot study testing whether targeted \"intraventricular mTOR inhibition\" can reduce ventricular inflammation and prevent hydrocephalus after severe brain hemorrhage. The medication will be delivered via temporary ventricular drains already in place as part of routine clinical care. The investigators will study safety, inflammation, CSF production, brain imaging changes, and whether patients ultimately require permanent shunts. Although this initial study focuses on adults with hemorrhage-related hydrocephalus, our long-term goal is to develop non-surgical therapies that could help children with hydrocephalus caused by prematurity or infection, especially in regions where access to neurosurgical care and shunt surgery is limited.",[74],"Post-hemorrhagic Hydrocephalus (PHH)",[76,77,78],"hydrocephalus","brain hemorrhage","mTOR Inhibition","NOT_YET_RECRUITING","2026-06-22",{"date":82,"type":83},"2026-06-25","ACTUAL",{"date":85,"type":67},"2027-01-01",{"date":87,"type":67},"2027-12-31",{"name":5,"class":6},1]