[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100448403":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":35,"centralContacts":43,"locations":49,"responsibleParty":66,"collaborators":68,"id":83,"slug":84,"hasResults":85,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":89,"eligibilityCriteria":90,"healthyVolunteers":85,"sex":91,"minAge":92,"maxAge":30,"enrollmentInfo":93,"targetDuration":30,"studyType":96,"phases":97,"briefSummary":99,"conditions":100,"keywords":103,"overallStatus":52,"whyStopped":30,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},{"fullName":5,"class":6},"IRRAS","INDUSTRY",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment Arm #1","EXPERIMENTAL","IRRAflow with manual tPA administration followed by Active Fluid Exchange",[13],"Device: IRRAflow",{"label":15,"type":10,"description":16,"interventionNames":17},"Treatment Arm #2","IRRAflow with continuous infusion of tPA combined with Active Fluid Exchange",[13],{"label":19,"type":20,"description":21,"interventionNames":22},"Treatment Arm #3","ACTIVE_COMPARATOR","Standard EVD with manual tPA administration",[23],"Device: EVD",[25,31],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DEVICE","IRRAflow","IRRAflow consists of a control unit and disposables (dual-lumen catheter and tube set) to offer an integrated and synchronized active fluid exchange system. Active fluid exchange is the combination of traditional gravity-driven drainage with periodic, controlled irrigation of the catheter probe to exchange any pathological fluid collection with neutral physiological fluids.",[9,15],null,{"type":26,"name":32,"description":33,"armGroupLabels":34,"otherNames":30},"EVD","An external ventricular drain (EVD), also known as a ventriculostomy or extraventricular drain, is a device used in neurosurgery to treat hydrocephalus and relieve elevated intracranial pressure when the normal flow of cerebrospinal fluid inside the brain is obstructed.",[19],[36,40],{"name":37,"affiliation":38,"role":39},"Behnam Rezai Jahromi, MD","University of Helsinki","PRINCIPAL_INVESTIGATOR",{"name":41,"affiliation":42,"role":39},"Babak Jahromi, MD","Northwestern University",[44],{"name":45,"role":46,"phone":47,"phoneExt":30,"email":48},"John Unser, MBA","CONTACT","19712195984","john.unser@irras.com",[50],{"facility":51,"status":52,"city":53,"state":30,"zip":30,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"Helsinki University","RECRUITING","Helsinki","Finland","FI",{"type":57,"coordinates":58},"Point",[59,60],24.93545,60.16952,{"lat":60,"lon":59},[63],{"name":37,"role":46,"phone":64,"phoneExt":30,"email":65},"+358 45 123 0273","behnam.rezai-jahromi@hus.fi",{"type":67,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR",[69,71,72,74,77,79,81],{"name":38,"class":70},"OTHER",{"name":42,"class":70},{"name":73,"class":70},"West Virginia University",{"name":75,"class":76},"Klinikum Bergmannstrost","UNKNOWN",{"name":78,"class":76},"Stony Brook University Hospital",{"name":80,"class":70},"Icahn School of Medicine at Mount Sinai",{"name":82,"class":76},"Buffalo General Medical Center","100448403","active-removal-of-intracerebral-hematoma-via-active-irrigation-100448403",false,"NCT05118997","Active Removal of IntraCerebral Hematoma Via Active Irrigation","Active Removal of IntraCerebral Hematoma Via Active Irrigation of the Ventricular System","ARCH","Inclusion Criteria:\n\n1. Age \\>18 years of age\n2. Need of EVD\n3. Active treatment\n4. Signed informed consent obtained\n\n   a. Based on institutional and country laws\n5. Spontaneous ICH with maximum 30 square cm's\n6. If needed, normal coagulation profile (PT, PTT, platelet count)\n7. Treatment within 72 hours of ictus\n8. Ability to administer 2.0 mg of tPA per day for 3 days\n\nExclusion Criteria:\n\n1. Age \\\u003C 18 years\n2. No need of EVD\n3. Patient has fixed and dilated pupils\n4. Coagulopathy uncorrectable\n5. Vascular pathology (e.g. Aneurysm involvement, AVM involvement)\n6. Pregnant women","ALL","18 Years",{"count":94,"type":95},60,"ESTIMATED","INTERVENTIONAL",[98],"NA","Study evaluating if active irrigation by IRRAflow® with infusion of tPA will reduce the time needed for clearance of intracerebral and intraventricular hemorrhage compared with passive drainage.",[101,102],"Cerebral Hemorrhage","Intraventricular Hemorrhage",[104,101,102],"Hemorrhage","2024-07-30",{"date":107,"type":108},"2024-08-01","ACTUAL",{"date":110,"type":108},"2021-10-25",{"date":112,"type":95},"2025-09",{"name":5,"class":6},1]