[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100459789":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":41,"locations":49,"responsibleParty":120,"collaborators":122,"id":131,"slug":132,"hasResults":133,"nctId":134,"briefTitle":135,"officialTitle":135,"acronym":136,"eligibilityCriteria":137,"healthyVolunteers":133,"sex":138,"minAge":139,"maxAge":140,"enrollmentInfo":141,"targetDuration":26,"studyType":144,"phases":145,"briefSummary":147,"conditions":148,"keywords":26,"overallStatus":76,"whyStopped":26,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":151,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":159},{"fullName":5,"class":6},"Region Skane","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Embolization of middle meningeal artery","EXPERIMENTAL","Participants receive endovascular treatment with embolization of the middle meningeal artery ipsilaterally to the chronic subdural hematoma(s).",[13],"Procedure: Endovascular treatment of the middle meningeal artery",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard neurosurgical hematoma evacuation and drainage","ACTIVE_COMPARATOR","Participants receive standard neurosurgical hematoma evacuation via burr hole or mini craniotomy and post-operative subdural or subgaleal drainage.",[19],"Procedure: Standard neurosurgical hematoma evacuation",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","Endovascular treatment of the middle meningeal artery","The middle meningeal artery on the same side(s) as the chronic subdural hematoma is embolized with liquid embolic agents.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"Standard neurosurgical hematoma evacuation","Standard neurosurgical evacuation of chronic subdural hematoma through burr-hole or mini craniotomy and postoperative subdural or subgaleal drainage.",[15],[32],"burr-hole, mini craniotomy",[34,38],{"name":35,"affiliation":36,"role":37},"Mattias Drake, MD","Skåne University Hospital, Lund University, Lund Sweden","PRINCIPAL_INVESTIGATOR",{"name":39,"affiliation":36,"role":40},"Johan Wassélius, MD, PhD","STUDY_DIRECTOR",[42,47],{"name":43,"role":44,"phone":45,"phoneExt":26,"email":46},"Åke Holmberg","CONTACT","+46739660740","ake.holmberg@regionstockholm.se",{"name":39,"role":44,"phone":26,"phoneExt":26,"email":48},"johan.wasselius@gmail.com",[50,74,86,103],{"facility":51,"status":52,"city":53,"state":26,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"Sahlgenska University Hospital","NOT_YET_RECRUITING","Gothenburg","41345","Sweden","SE",{"type":58,"coordinates":59},"Point",[60,61],11.96679,57.70716,{"lat":61,"lon":60},[64,67,70,71],{"name":65,"role":44,"phone":26,"phoneExt":26,"email":66},"Erik Ceder, MD, PhD","erik.ceder@vgregion.se",{"name":68,"role":44,"phone":26,"phoneExt":26,"email":69},"Magnus Tisell, MD, PhD","magnus.tisell@gu.se",{"name":68,"role":37,"phone":26,"phoneExt":26,"email":26},{"name":72,"role":73,"phone":26,"phoneExt":26,"email":26},"Andreas Bartley, MD","SUB_INVESTIGATOR",{"facility":75,"status":76,"city":77,"state":26,"zip":78,"country":55,"countryCode":56,"cosmosGeoPoint":79,"geoPoint":83,"contacts":84},"Skåne University Hospital","RECRUITING","Lund","22185",{"type":58,"coordinates":80},[81,82],13.19321,55.70584,{"lat":82,"lon":81},[85],{"name":43,"role":44,"phone":45,"phoneExt":26,"email":46},{"facility":87,"status":52,"city":88,"state":26,"zip":89,"country":55,"countryCode":56,"cosmosGeoPoint":90,"geoPoint":94,"contacts":95},"Karolinska Hospital","Stockholm","17176",{"type":58,"coordinates":91},[92,93],18.06871,59.32938,{"lat":93,"lon":92},[96,99,102],{"name":97,"role":44,"phone":26,"phoneExt":26,"email":98},"Fabian Arnberg, MD, PhD","fabian.arnberg@regionstockholm.se",{"name":100,"role":44,"phone":26,"phoneExt":26,"email":101},"Jiri Bartek, MD, PhD","jiri.bartek@ki.se",{"name":97,"role":37,"phone":26,"phoneExt":26,"email":26},{"facility":104,"status":76,"city":105,"state":26,"zip":106,"country":55,"countryCode":56,"cosmosGeoPoint":107,"geoPoint":111,"contacts":112},"Norrlands Universitetssjukhus","Umeå","90737",{"type":58,"coordinates":108},[109,110],20.25972,63.82842,{"lat":110,"lon":109},[113,116,119],{"name":114,"role":44,"phone":26,"phoneExt":26,"email":115},"Peter Lindvall, MD, PhD","Peter.Lindvall@regionvasterbotten.se",{"name":117,"role":44,"phone":26,"phoneExt":26,"email":118},"Alexander Henze, MD","Alexander.Henze@regionvasterbotten.se",{"name":114,"role":37,"phone":26,"phoneExt":26,"email":26},{"type":121,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[123,125,127,129],{"name":124,"class":6},"Lund University",{"name":126,"class":6},"Sahlgrenska University Hospital",{"name":128,"class":6},"Karolinska University Hospital",{"name":130,"class":6},"Norrlands University Hospital","100459789","swedish-trial-on-embolization-of-middle-meningeal-artery-versus-surgical-evacuation-in-chronic-subdural-hematoma-100459789",false,"NCT05267184","Swedish Trial on Embolization of Middle Meningeal Artery Versus Surgical Evacuation in Chronic Subdural Hematoma","SWEMMA","Inclusion Criteria:\n\n1. Men and women 18-89 y\u002Fo\n2. Non-contrast Computed Tomography (NCCT)- or Magnetic Resonance Imaging (MRI)- verified, previously unoperated uni- or bilateral cSDH\n3. Clinical and\u002For radiological status indicating neurosurgical treatment\n4. Markwalder Scale score \\\u003C2\n5. Glasgow coma Scale score \\>13\n6. Able to provide signed informed consent\n\nExclusion Criteria:\n\n1. Acute subdural hematoma\n2. Focal, non-hemispheric cSDH\n3. Midline shift \\>10 mm and\u002For effaced basal cisterns and\u002For significant dilatation of one or both lateral ventricle temporal horns and\u002For incipient uncal herniation\n4. Structural pathology causing the cSDH (e.g. dural AV-fistula, AVM, tumor, arachnoid cyst, ventriculoperitoneal shunt)\n5. Contraindications to angiography\n6. Dependency defined as mRS \\>3\n7. Life expectancy \\\u003C6 months\n8. Comorbidity deemed making follow up impossible\n9. Participation in other interventional clinical study\n10. Pregnancy","ALL","18 Years","89 Years",{"count":142,"type":143},288,"ESTIMATED","INTERVENTIONAL",[146],"NA","The SWEMMA trial is an open, national, multi-center, prospective, randomized (1:1), superiority trial designed to assess impact on reoperation rates for chronic subdural hematoma with a head-to-head comparison of embolization of the middle meningeal artery (intervention) with standard neurosurgical hematoma evacuation (control).",[149],"Chronic Subdural Hematoma","2024-04-08",{"date":152,"type":153},"2024-04-09","ACTUAL",{"date":155,"type":153},"2022-03-28",{"date":157,"type":143},"2027-03",{"name":5,"class":6},4]