[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100491658":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":46,"responsibleParty":195,"collaborators":197,"id":216,"slug":217,"hasResults":218,"nctId":219,"briefTitle":220,"officialTitle":221,"acronym":222,"eligibilityCriteria":223,"healthyVolunteers":218,"sex":224,"minAge":225,"maxAge":226,"enrollmentInfo":227,"targetDuration":26,"studyType":230,"phases":231,"briefSummary":233,"conditions":234,"keywords":236,"overallStatus":48,"whyStopped":26,"lastUpdateSubmitDate":246,"lastUpdatePostDateStruct":247,"startDateStruct":250,"completionDateStruct":252,"leadSponsor":254,"locationsCount":255},{"fullName":5,"class":6},"University Hospital, Basel, Switzerland","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Study Intervention","EXPERIMENTAL","Early minimally invasive image guided endoscopic hematoma evacuation as an add-on therapy to BMT performed within 24 hours after SSICH symptom onset.",[13,14],"Procedure: Early minimally invasive image guided endoscopic hematoma evacuation","Procedure: Best medical treatment (BMT)",{"label":16,"type":17,"description":18,"interventionNames":19},"Control Intervention","ACTIVE_COMPARATOR","Best medical treatment i.e. active blood pressure control, seizure prophylaxis and care as according to the current guidelines.",[14],[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","Early minimally invasive image guided endoscopic hematoma evacuation","The intervention group will first receive BMT (as defined below) upon admission and early minimally invasive image guided endoscopic hematoma evacuation as an add-on therapy to BMT. Surgery will be performed within 6-24 hours after SSICH symptom onset. Surgery will be performed in an emergency operating theatre or a hybrid operation theatre equipped with intraoperative CT (in hybrid OR), neuronavigation, and neuro-endoscopy.The position and progress of the trocar towards the hematoma cavity will be monitored with neuro-navigation. The endoscope (LOTTA® system, Karl Storz Endoscopes, Germany; Minop®, BBraun, Tuttlingen, Germany or equivalent) will be inserted into the trocar and tracked using neuro-navigation. Using the pre-planned trajectory, the hematoma will be entered. Using continuous suction and irrigation, the hematoma will be aspirated and\u002For washed out.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Best medical treatment (BMT)","The control group will receive the current gold standard treatment for SSICH according to the guidelines (BMT). This involves strict blood pressure control (SBP\\\u003C140mmHg), if needed with intravenous or intraarterial blood pressure lowering agents, reversal of anticoagulation if applicable, intensive care surveillance and nursing on a ICU or stroke unit, control of seizures as well as glucose levels as needed and neurointensive monitoring if deemed necessary",[16,9],[32],{"name":33,"affiliation":34,"role":35},"Jehuda Soleman, Prof. Dr. med.","Department of Neurosurgery, University Hospital Basel","PRINCIPAL_INVESTIGATOR",[37,42],{"name":38,"role":39,"phone":40,"phoneExt":26,"email":41},"Raphael Guzman, Prof. Dr. med.","CONTACT","+41 61 265 33 68","raphael.guzman@usb.ch",{"name":43,"role":39,"phone":44,"phoneExt":26,"email":45},"Tim Hallenberger, Dr.","+41 61 556 55 01","tim.hallenberger@usb.ch",[47,68,82,96,110,124,138,152,166,180],{"facility":34,"status":48,"city":49,"state":26,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"RECRUITING","Basel","4031","Switzerland","CH",{"type":54,"coordinates":55},"Point",[56,57],7.57327,47.55839,{"lat":57,"lon":56},[60,62,63,64,67],{"name":33,"role":39,"phone":26,"phoneExt":26,"email":61},"jehuda.soleman@usb.ch",{"name":43,"role":39,"phone":26,"phoneExt":26,"email":45},{"name":33,"role":35,"phone":26,"phoneExt":26,"email":26},{"name":65,"role":66,"phone":26,"phoneExt":26,"email":26},"Urs Fischer, Prof. Dr. med.","SUB_INVESTIGATOR",{"name":43,"role":66,"phone":26,"phoneExt":26,"email":26},{"facility":69,"status":48,"city":70,"state":26,"zip":26,"country":51,"countryCode":52,"cosmosGeoPoint":71,"geoPoint":75,"contacts":76},"University Hospital Bern","Bern",{"type":54,"coordinates":72},[73,74],7.44744,46.94809,{"lat":74,"lon":73},[77,81],{"name":78,"role":39,"phone":79,"phoneExt":26,"email":80},"Andreas Raabe, Prof. Dr. med.","+41 31 632 24 09","andreas.raabe@insel.ch",{"name":78,"role":35,"phone":26,"phoneExt":26,"email":26},{"facility":83,"status":48,"city":84,"state":26,"zip":26,"country":51,"countryCode":52,"cosmosGeoPoint":85,"geoPoint":89,"contacts":90},"Hopitaux Universitare Geneve","Geneva",{"type":54,"coordinates":86},[87,88],6.14569,46.20222,{"lat":88,"lon":87},[91,95],{"name":92,"role":39,"phone":93,"phoneExt":26,"email":94},"Philippe Bijlenga, Prof. Dr. med.","+41 22 372 82 01","philippe.bijlenga@hcuge.ch",{"name":92,"role":35,"phone":26,"phoneExt":26,"email":26},{"facility":97,"status":48,"city":98,"state":26,"zip":26,"country":51,"countryCode":52,"cosmosGeoPoint":99,"geoPoint":103,"contacts":104},"Centre Hopitalier Universitaire Vaudoise","Lausanne",{"type":54,"coordinates":100},[101,102],6.63282,46.516,{"lat":102,"lon":101},[105,109],{"name":106,"role":39,"phone":107,"phoneExt":26,"email":108},"Mahmoud Messerer, PD Dr.","+41 21 314 12 93","Mahmoud.Messerer@chuv.ch",{"name":106,"role":35,"phone":26,"phoneExt":26,"email":26},{"facility":111,"status":48,"city":112,"state":26,"zip":26,"country":51,"countryCode":52,"cosmosGeoPoint":113,"geoPoint":117,"contacts":118},"Luzerner Kantonsspital","Lucerne",{"type":54,"coordinates":114},[115,116],8.30635,47.05048,{"lat":116,"lon":115},[119,123],{"name":120,"role":39,"phone":121,"phoneExt":26,"email":122},"Ulf C. Schneider, Prof. Dr. med.","+41 41 205 45 04","neurochirurgie@luks.ch",{"name":120,"role":35,"phone":26,"phoneExt":26,"email":26},{"facility":125,"status":48,"city":126,"state":26,"zip":26,"country":51,"countryCode":52,"cosmosGeoPoint":127,"geoPoint":131,"contacts":132},"Ospedale Regionale di Lugano","Lugano",{"type":54,"coordinates":128},[129,130],8.96004,46.01008,{"lat":130,"lon":129},[133,137],{"name":134,"role":39,"phone":135,"phoneExt":26,"email":136},"Andrea Cardia, Dr. med.","+41 91 811 69 27","andrea.cardia@eoc.ch",{"name":134,"role":35,"phone":26,"phoneExt":26,"email":26},{"facility":139,"status":48,"city":140,"state":26,"zip":26,"country":51,"countryCode":52,"cosmosGeoPoint":141,"geoPoint":145,"contacts":146},"Kantonsspital St. Gallen","Sankt Gallen",{"type":54,"coordinates":142},[143,144],9.37477,47.42391,{"lat":144,"lon":143},[147,151],{"name":148,"role":39,"phone":149,"phoneExt":26,"email":150},"lsabel Hostettler, PD Dr. Dr.","+41 71 494 11 99","neurochirurgie@kssg.ch",{"name":148,"role":35,"phone":26,"phoneExt":26,"email":26},{"facility":153,"status":48,"city":154,"state":26,"zip":26,"country":51,"countryCode":52,"cosmosGeoPoint":155,"geoPoint":159,"contacts":160},"Centre Hopitalier Universitaire du Valais Romand","Sion",{"type":54,"coordinates":156},[157,158],7.35559,46.22739,{"lat":158,"lon":157},[161,165],{"name":162,"role":39,"phone":163,"phoneExt":26,"email":164},"Jean-Yves Fournier, PD Dr. Dr.","+41 27 603 45 30","chvr.consult.neurochirurgie@hopitalvs.ch",{"name":162,"role":35,"phone":26,"phoneExt":26,"email":26},{"facility":167,"status":48,"city":168,"state":26,"zip":26,"country":51,"countryCode":52,"cosmosGeoPoint":169,"geoPoint":173,"contacts":174},"Kantonsspital Winterthur","Winterthur",{"type":54,"coordinates":170},[171,172],8.72413,47.50564,{"lat":172,"lon":171},[175,179],{"name":176,"role":39,"phone":177,"phoneExt":26,"email":178},"Alex Alfieri, Prof. Dr.","+41 52 266 29 72","neurochirurgie@ksw.ch",{"name":176,"role":35,"phone":26,"phoneExt":26,"email":26},{"facility":181,"status":182,"city":183,"state":26,"zip":26,"country":51,"countryCode":52,"cosmosGeoPoint":184,"geoPoint":188,"contacts":189},"Universitätsspital Zürich","NOT_YET_RECRUITING","Zurich",{"type":54,"coordinates":185},[186,187],8.55,47.36667,{"lat":187,"lon":186},[190,194],{"name":191,"role":39,"phone":192,"phoneExt":26,"email":193},"Kevin Akeret, Dr. Dr.","+41 44 255 26 86","kevin.akeret@usz.ch",{"name":191,"role":35,"phone":26,"phoneExt":26,"email":26},{"type":196,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[198,200,202,204,205,207,209,211,213,215],{"name":199,"class":6},"Swiss National Science Foundation",{"name":201,"class":6},"University Hospital, Geneva",{"name":203,"class":6},"Cantonal Hospital of St. Gallen",{"name":125,"class":6},{"name":206,"class":6},"Centre Hospitalier Universitaire Vaudois",{"name":208,"class":6},"Hôpital du Valais",{"name":210,"class":6},"University Hospital, Zürich",{"name":212,"class":6},"Kantonsspital Winterthur KSW",{"name":214,"class":6},"Insel Gruppe AG, University Hospital Bern",{"name":111,"class":6},"100491658","early-minimally-invasive-image-guided-endoscopic-evacuation-of-intracerebral-haemorrhage-eminent-ich-100491658",false,"NCT05681988","Early Minimally Invasive Image Guided Endoscopic Evacuation of Intracerebral Haemorrhage (EMINENT-ICH)","Early Minimally Invasive Image Guided Endoscopic Evacuation of Intracerebral Haemorrhage (EMINENT-ICH): a Randomized Controlled Trial","EMINENT-ICH","Inclusion Criteria:\n\n* Spontaneous supratentorial intracerebral hemorrhage (SSICH), defined as the sudden occurrence of bleeding into the lobar parenchyma and\u002For into the basal ganglia and\u002For thalamus that may extend into the ventricles confirmed by imaging\n* SSICH volume ≥20 mL \\\u003C100 mL\n* A focal neurological deficit consisting of either\n\n  * clinically relevant hemiparesis (≥4 motor points on the NIHSS for facial palsy, motoric upper and lower extremities combined)\n  * clinically relevant motor or sensory aphasia (≥2 points on the NIHSS)\n  * clinically relevant hemi-inattention (formerly neglect, 2 points on the NIHSS)\n  * decreased level of consciousness (Glasgow Coma Scale (GCS)≤13)\n* Presenting GCS 5 - 15 (in intubated patients GCS assessment will be performed after Rutledge et al. or if impossible, the last pre-intubation GCS will be used)\n* Endoscopic hematoma evacuation can be initiated within 24 hours after the patient was last seen well\u002Fsymptom onset\n* Informed consent of patient or appropriate surrogate (for patients without competence)\n\nExclusion Criteria:\n\n* SSICH due to known or suspected structural abnormality in the brain (e.g. vascular malformation, aneurysm, arteriovenous malformation (AVM), brain tumor) and\u002For brain trauma and\u002For hemorrhagic conversion of an ischemic infarction\n* Multiple simultaneous intracranial hemorrhages (ICH) (e.g. multifocal ICH, chronic subdural hematoma (cSDH), acute subdural hematoma (aSDH), SAH)\n* Infratentorial hemorrhage or midbrain extension\u002Finvolvement of the hemorrhage\n* Coagulation disorder (including anticoagulation) with an international normalized ratio (INR) of \\>1.5 which cannot be pharmacologically reverted until the planned time of evacuation\n* Pregnancy\n* Relevant disability prior to SSICH (mRS \\>2)\n* Any comorbid disease or condition expected to compromise survival or ability to complete follow-up assessments through 180 days (e.g. bilateral fixed dilated pupils)","ALL","18 Years","85 Years",{"count":228,"type":229},200,"ESTIMATED","INTERVENTIONAL",[232],"NA","This is an open-labelled, single centre randomised controlled trial evaluating the efficacy of early minimally invasive image-guided hematoma evacuation in combination with the current best medical treatment compared to best medical treatment alone in improving functional outcome rates at 6 months after initial treatment in patients with spontaneous supratentorial intracerebral haemorrhage.",[235],"Intracerebral Haemorrhage",[237,238,239,240,241,242,243,244,245],"spontaneous supratentorial intracerebral haemorrhage (SSICH)","best medical treatment (BMT)","surgical hematoma evacuation","conventional craniotomy (CC)","early image-guided endoscopic surgery","endoscopic surgery (ES)","minimally invasive surgery (MIS)","minimally invasive puncture surgery (MIPS)","stereotactic aspiration (SA)","2024-07-19",{"date":248,"type":249},"2024-07-22","ACTUAL",{"date":251,"type":249},"2024-01-01",{"date":253,"type":229},"2029-12",{"name":5,"class":6},10]