[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"post-hemorrhagic-hydrocephalus-phh\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:post-hemorrhagic-hydrocephalus-phh":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,46],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100643971","phase-1-ventricular-mtor-inhibition-to-prevent-hydrocephalus-after-brain-hemorrhage-100643971",false,"NCT07662174","Ventricular mTOR Inhibition to Prevent Hydrocephalus After Brain Hemorrhage","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":20,"type":21},15,"ESTIMATED","INTERVENTIONAL",[24,25],"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.",[28],"Post-hemorrhagic Hydrocephalus (PHH)",[30,31,32],"hydrocephalus","brain hemorrhage","mTOR Inhibition","NOT_YET_RECRUITING","2026-06-22",{"date":36,"type":37},"2026-06-25","ACTUAL",{"date":39,"type":21},"2027-01-01",{"date":41,"type":21},"2027-12-31",{"name":43,"class":44},"Massachusetts General Hospital","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":56,"conditions":57,"keywords":58,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":45},"100592555","phase-1-assessing-csf-flow-dynamics-in-pediatric-hemorrhagic-hydrocephalus-100592555","NCT06994949","Assessing CSF Flow Dynamics in Pediatric Hemorrhagic Hydrocephalus","Inclusion Criteria:\n\n* Children born premature currently in the NICU with a diagnosis of PHH who have undergone ventricular reservoir placement.\n* For the first four study subjects, we will attempt for the child to undergo CT cisternography when clinically stable 3-4 weeks after reservoir placement.\n\nExclusion Criteria:\n\n* Parents who do not consent for procedure on their child\n* Children who are deemed clinically unstable or unsuitable for imaging by clinical staff as defined by the subject's level of intensive care (e.g. can the subject be repositioned without compromise to the level of care needed or condition)\n* Children known or suspected to have allergy to iodine or ICG\n* Children who do not have a subcutaneous reservoir for CSF diversion from the lateral ventricle","6 Months",{"count":54,"type":21},20,[24],"The purpose of this study is to evaluate the safety and efficacy of ventricular microdosing of indocyanine green (ICG) in order to assess cerebrospinal fluid (CSF) ventricular dynamics and extracranial CSF outflow using fluorescent Cap-based Transcranial Optical Tomography (fCTOT) and Near-InfraRed Fluorescent (NIRF) imaging and to evaluate inflammation markers of the CSF and to correlate with CSF ventricular dynamics, extracranial outflow into the lymphatics, ventriculomegaly, and patient's clinical outcome in order to understand how inflammation may impact that status of extracranial outflow.",[28],[59,60,61],"cerebrospinal fluid (CSF)","premature infants","indocyanine green (ICG)","RECRUITING","2025-05-20",{"date":65,"type":37},"2025-05-29",{"date":67,"type":37},"2025-01-14",{"date":69,"type":21},"2029-01-03",{"name":71,"class":44},"Eva Sevick"]