[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100459789":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":41,"locations":49,"responsibleParty":119,"collaborators":121,"id":130,"slug":26,"hasResults":131,"nctId":132,"briefTitle":133,"officialTitle":133,"acronym":134,"eligibilityCriteria":135,"healthyVolunteers":131,"sex":136,"minAge":137,"maxAge":138,"enrollmentInfo":139,"targetDuration":26,"studyType":142,"phases":143,"briefSummary":145,"conditions":146,"keywords":26,"overallStatus":75,"whyStopped":26,"lastUpdateSubmitDate":148,"lastUpdatePostDateStruct":149,"startDateStruct":152,"completionDateStruct":154,"leadSponsor":156,"locationsCount":157},{"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",[50,73,85,102],{"facility":51,"status":52,"city":53,"state":26,"zip":54,"country":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"Sahlgenska University Hospital","NOT_YET_RECRUITING","Gothenburg","41345","Sweden",{"type":57,"coordinates":58},"Point",[59,60],11.96679,57.70716,{"lat":60,"lon":59},[63,66,69,70],{"name":64,"role":44,"phone":26,"phoneExt":26,"email":65},"Erik Ceder, MD, PhD","erik.ceder@vgregion.se",{"name":67,"role":44,"phone":26,"phoneExt":26,"email":68},"Magnus Tisell, MD, PhD","magnus.tisell@gu.se",{"name":67,"role":37,"phone":26,"phoneExt":26,"email":26},{"name":71,"role":72,"phone":26,"phoneExt":26,"email":26},"Andreas Bartley, MD","SUB_INVESTIGATOR",{"facility":74,"status":75,"city":76,"state":26,"zip":77,"country":55,"cosmosGeoPoint":78,"geoPoint":82,"contacts":83},"Skåne University Hospital","RECRUITING","Lund","22185",{"type":57,"coordinates":79},[80,81],13.19321,55.70584,{"lat":81,"lon":80},[84],{"name":43,"role":44,"phone":45,"phoneExt":26,"email":46},{"facility":86,"status":52,"city":87,"state":26,"zip":88,"country":55,"cosmosGeoPoint":89,"geoPoint":93,"contacts":94},"Karolinska Hospital","Stockholm","17176",{"type":57,"coordinates":90},[91,92],18.06871,59.32938,{"lat":92,"lon":91},[95,98,101],{"name":96,"role":44,"phone":26,"phoneExt":26,"email":97},"Fabian Arnberg, MD, PhD","fabian.arnberg@regionstockholm.se",{"name":99,"role":44,"phone":26,"phoneExt":26,"email":100},"Jiri Bartek, MD, PhD","jiri.bartek@ki.se",{"name":96,"role":37,"phone":26,"phoneExt":26,"email":26},{"facility":103,"status":75,"city":104,"state":26,"zip":105,"country":55,"cosmosGeoPoint":106,"geoPoint":110,"contacts":111},"Norrlands Universitetssjukhus","Umeå","90737",{"type":57,"coordinates":107},[108,109],20.25972,63.82842,{"lat":109,"lon":108},[112,115,118],{"name":113,"role":44,"phone":26,"phoneExt":26,"email":114},"Peter Lindvall, MD, PhD","Peter.Lindvall@regionvasterbotten.se",{"name":116,"role":44,"phone":26,"phoneExt":26,"email":117},"Alexander Henze, MD","Alexander.Henze@regionvasterbotten.se",{"name":113,"role":37,"phone":26,"phoneExt":26,"email":26},{"type":120,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[122,124,126,128],{"name":123,"class":6},"Lund University",{"name":125,"class":6},"Sahlgrenska University Hospital",{"name":127,"class":6},"Karolinska University Hospital",{"name":129,"class":6},"Norrlands University Hospital","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":140,"type":141},288,"ESTIMATED","INTERVENTIONAL",[144],"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).",[147],"Chronic Subdural Hematoma","2024-04-08",{"date":150,"type":151},"2024-04-09","ACTUAL",{"date":153,"type":151},"2022-03-28",{"date":155,"type":141},"2027-03",{"name":5,"class":6},4]