[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100489191":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":38,"locations":48,"responsibleParty":76,"collaborators":78,"id":82,"slug":83,"hasResults":84,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":88,"eligibilityCriteria":89,"healthyVolunteers":84,"sex":90,"minAge":91,"maxAge":43,"enrollmentInfo":92,"targetDuration":43,"studyType":95,"phases":96,"briefSummary":98,"conditions":99,"keywords":43,"overallStatus":51,"whyStopped":43,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":113},{"fullName":5,"class":6},"Ohio State University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"IRRAflow with Active Fluid Exchange System (IRRAflow)","EXPERIMENTAL","Subjects may be randomized to receive the IRRAflow with Active Fluid Exchange System (intervention) for intracranial pressure monitoring and for externally draining intracranial fluid as a means of reducing intracranial pressure.",[13],"Device: IRRAflow with Active Fluid Exchange System",{"label":15,"type":16,"description":17,"interventionNames":18},"External Ventricular Drainage (EVD)","ACTIVE_COMPARATOR","Subjects may be randomized to receive an External Ventricular Drain (control) for intracranial pressure monitoring and for externally draining intracranial fluid as a means of reducing intracranial pressure.",[19],"Device: External Ventricular Drain",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","IRRAflow with Active Fluid Exchange System","IRRAflow® Active Fluid Exchange System is an intracranial drainage system intended for use by professional medical hospital personnel, trained and experienced in neurosurgical medical care.\n\nThe intracranial pressure is kept at a safe level by draining excessive intracranial fluid. The system incorporates an irrigation support mechanism, used to irrigate the system in a controlled, programmed manner to minimize catheter occlusion. Additionally, a manual bolus can be given to facilitate keeping the catheter clear of occlusion or to clear the catheter of occlusion if one is present. This mechanism works by producing a bolus pulse using short periods of high flow (i.e. flow pulses).",[9],[27],"IRRAflow",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"External Ventricular Drain","The External Ventricular Drain (EVD) is used standard of care at the study site for ventricular drainage.",[15],[33],"EVD",[35],{"name":36,"affiliation":5,"role":37},"Patrick Youssef, MD","PRINCIPAL_INVESTIGATOR",[39,45],{"name":40,"role":41,"phone":42,"phoneExt":43,"email":44},"Edouard Beliaire","CONTACT","6143666936",null,"edouard.belizaire@osumc.edu",{"name":36,"role":41,"phone":46,"phoneExt":43,"email":47},"6143666590","patrick.youssef@osumc.edu",[49],{"facility":50,"status":51,"city":52,"state":53,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"The Ohio State University Wexner Medical Center","RECRUITING","Columbus","Ohio","43210","United States","US",{"type":58,"coordinates":59},"Point",[60,61],-82.99879,39.96118,{"lat":61,"lon":60},[64,66,69,71,74],{"name":65,"role":41,"phone":43,"phoneExt":43,"email":44},"Edouard Belizaire",{"name":67,"role":41,"phone":43,"phoneExt":43,"email":68},"Uchechi Okafor","Uchechi.Okafor@osumc.edu",{"name":70,"role":37,"phone":43,"phoneExt":43,"email":43},"Patrick Youssef",{"name":72,"role":73,"phone":43,"phoneExt":43,"email":43},"Shahid Nimjee","SUB_INVESTIGATOR",{"name":75,"role":73,"phone":43,"phoneExt":43,"email":43},"Ciaran Powers",{"type":37,"investigatorFullName":70,"investigatorTitle":77,"investigatorAffiliation":5,"oldNameTitle":43,"oldOrganization":43},"Clinical Assistant Professor of Neurological Surgery",[79],{"name":80,"class":81},"IRRAS","INDUSTRY","100489191","affect-study-for-patients-with-intraventricular-hemorrhage-subarachnoid-hemorrhage-subdural-hematoma-and-ventriculitis-100489191",false,"NCT05649904","AFFECT Study for Patients With Intraventricular Hemorrhage, Subarachnoid Hemorrhage, Subdural Hematoma, and Ventriculitis","Use of Active Fluid Exchange to Therapeutically Treat Intracranial Bleeding and Infection","AFFECT","Inclusion Criteria:\n\n1. Age ≥18 years of age\n2. Need of drainage for one of the following underlying conditions: Intraventricular hemorrhage, intracranial hemorrhage, subarachnoid hemorrhage, chronic subdural hematoma and ventriculitis\n3. Indication for active treatment evaluated by treating physician for underlying conditions; Intraventricular hemorrhage, subarachnoid hemorrhage, chronic subdural hematoma and ventriculitis\n4. Signed informed consent obtained by subject or Legally Authorized Representative\n\nExclusion Criteria:\n\n1. Subject has fixed and dilated pupils\n2. Pregnant women\n3. Presence of Moyamoya\n4. History or presence of clotting disorder.\n5. Platelet count less than 100,000, INR greater than 1.4","ALL","18 Years",{"count":93,"type":94},240,"ESTIMATED","INTERVENTIONAL",[97],"NA","The goal of this clinical trial is to evaluate efficacy and safety of evacuation of cerebrospinal fluid, blood, and harmful bacteria from the intraventricular, subdural and subarachnoid spaces by Active Controlled Irrigation and Drainage (IRRAflow) compared to Passive External Ventricular Drainage (EVD).\n\nSubjects with intraventricular hemorrhage, subarachnoid hemorrhage, subdural bleeding, and ventriculitis will be randomized to receive the IRRAflow device or EVD device and followed for one month post-procedure to compare outcomes between the subject groups.",[100,101,102,103],"Intraventricular Hemorrhage","Subarachnoid Hemorrhage","Subdural Hematoma","Ventriculitis","2025-03-26",{"date":106,"type":107},"2025-04-01","ACTUAL",{"date":109,"type":107},"2023-02-07",{"date":111,"type":94},"2026-01",{"name":5,"class":6},1]