[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100553306":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":28,"locations":34,"responsibleParty":50,"collaborators":52,"id":98,"slug":99,"hasResults":100,"nctId":101,"briefTitle":102,"officialTitle":102,"acronym":103,"eligibilityCriteria":104,"healthyVolunteers":100,"sex":105,"minAge":106,"maxAge":25,"enrollmentInfo":107,"targetDuration":25,"studyType":110,"phases":111,"briefSummary":113,"conditions":114,"keywords":117,"overallStatus":37,"whyStopped":25,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":132},{"fullName":5,"class":6},"The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Robot-Assisted Endoscopic Minimally Invasive Surgery","EXPERIMENTAL","Neurosurgeons participating in the robot-assisted endoscopic procedure must be qualified doctors who have completed standardized training and certification by the coordinating center. They must be capable of performing endoscopic hematoma evacuation and managing common intraoperative complications. Each certified surgeon is required to regularly review the surgical protocol and the technical components of the procedure.\n\nSurgical trajectory: The incision and burr-hole location are determined using an AI-integrated neuroimaging automatic surgical trajectory planning system. The planning principles include, but are not limited to: avoiding critical functional areas such as language and motor cortices; avoiding vascular-dense regions; and selecting the individualized optimal trajectory based on the three-dimensional morphology and spatial orientation of the hematoma.\n\nPlan review by supporting units: All preoperative imaging data and trajectory plans are automatically stored and uploaded",[13],"Procedure: Robot-Assisted Endoscopic Minimally Invasive Surgery",{"label":15,"type":16,"description":17,"interventionNames":18},"Traditional Surgical Approaches","SHAM_COMPARATOR","A small craniotomy or large bone flap craniotomy is performed to microscopically evacuate the basal ganglia hematoma, followed by electrocoagulation for hemostasis. Depending on preoperative brain herniation or intraoperative brain swelling, the surgeon may decide whether to remove the bone flap.",[19],"Procedure: Traditional Surgical Approaches",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"PROCEDURE","Neurosurgeons participating in the robot-assisted endoscopic procedure must be qualified doctors who have completed standardized training and certification by the coordinating center. They must be capable of performing endoscopic hematoma evacuation and managing common intraoperative complications. Each certified surgeon is required to regularly review the surgical protocol and the technical components of the procedure.\n\nSurgical trajectory: The incision and burr-hole location are determined using an AI-integrated neuroimaging automatic surgical trajectory planning system. The planning principles include, but are not limited to: avoiding critical functional areas such as language and motor cortices; avoiding vascular-dense regions; and selecting the individualized optimal trajectory based on the three-dimensional morphology and spatial orientation of the hematoma.\n\nPlan review by supporting units: All preoperative imaging data and trajectory plans are automatically stored and uploaded b",[9],null,{"type":22,"name":15,"description":17,"armGroupLabels":27,"otherNames":25},[15],[29],{"name":30,"role":31,"phone":32,"phoneExt":25,"email":33},"Chun-Hua Hang, PhD","CONTACT","025-83106666","hang_neurosurgery@163.com",[35],{"facility":36,"status":37,"city":38,"state":25,"zip":25,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"The Affiliated Drum Tower Hospital of Nanjing University Medical School","RECRUITING","Nanjing","China","CN",{"type":42,"coordinates":43},"Point",[44,45],118.77778,32.06167,{"lat":45,"lon":44},[48],{"name":49,"role":31,"phone":32,"phoneExt":25,"email":33},"Chunhua Hang",{"type":51,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[53,55,57,59,61,63,65,67,69,71,73,75,77,79,81,83,85,87,89,91,93,95],{"name":54,"class":6},"Second Affiliated Hospital, School of Medicine, Zhejiang University",{"name":56,"class":6},"Affiliated Hospital of Nantong University",{"name":58,"class":6},"The First People's Hospital of Lianyungang",{"name":60,"class":6},"Huashan Hospital",{"name":62,"class":6},"China-Japan Friendship Hospital",{"name":64,"class":6},"The First Affiliated Hospital of Zhengzhou University",{"name":66,"class":6},"Second Affiliated Hospital of Xi'an Jiaotong University",{"name":68,"class":6},"Shaoxing Central Hospital",{"name":70,"class":6},"Jinhua Central Hospital",{"name":72,"class":6},"The Second Affiliated Hospital of Kunming Medical University",{"name":74,"class":6},"First Affiliated Hospital of Guangxi Medical University",{"name":76,"class":6},"First Affiliated Hospital of Chongqing Medical University",{"name":78,"class":6},"Shanghai East Hospital",{"name":80,"class":6},"The First Affiliated Hospital of Anhui Medical University",{"name":82,"class":6},"Renmin Hospital of Wuhan University",{"name":84,"class":6},"The First Affiliated Hospital of Nanchang University",{"name":86,"class":6},"Aerospace Center Hospital",{"name":88,"class":6},"Hebei General Hospital",{"name":90,"class":6},"First Affiliated Hospital of Harbin Medical University",{"name":92,"class":6},"The Affiliated Hospital of Inner Mongolia Medical University",{"name":94,"class":6},"Jinshan Hospital Fudan University",{"name":96,"class":97},"Minhang District Central Hospital of Shanghai","UNKNOWN","100553306","a-multicenter-randomlzed-controlled-umbrella-trial-for-minimally-invasive-neurosurgery-with-al-assisted-robotic-guidance-for-hemorrhagic-stroke-large-basal-ganglia-hemorrhage-100553306",false,"NCT06484374","A Multicenter, RAndomlzed, coNtrolled, umBrella Trial fOr Minimally Invasive Neurosurgery With Al-assisted Robotic guidanCe for Hemorrhagic Stroke: Large Basal Ganglia Hemorrhage","RAINBOW-LBH","Inclusion Criteria:\n\n1. Age ≥18 years at randomization;\n2. Diagnosed with hypertensive basal ganglia hemorrhage via imaging (CT, CTA, etc.);\n3. Hematoma volume ≥30 mL prior to randomization;\n4. Glasgow Coma Scale (GCS) score ≥ 5;\n5. Available for surgery within 72 hours after onset;\n6. Modified Rankin Scale (mRS) score ≤ 1 prior to this hemorrhage;\n7. Informed consent obtained in accordance with national laws, regulations, and applicable ethics committee requirements.\n\nExclusion Criteria:\n\n1. Hematoma involving the thalamus (volume \\>5 mL or diameter \\>2 cm), midbrain, or ventricles (Graeb score ≥3), or other locations;\n2. Radiologically confirmed cerebral vascular abnormalities including ruptured aneurysms, arteriovenous malformations (AVMs), or Moyamoya disease; hemorrhagic transformation of ischemic infarcts; or recent (within 1 year) recurrence of intracerebral hemorrhage;\n3. Signs of impending herniation such as midline shift exceeding 1 cm or ipsilateral pupillary changes;\n4. Any irreversible coagulation disorder or known coagulopathy; platelet count \\\u003C100,000; INR \\>1.4; or use of anticoagulant medication within 7 days before the current hemorrhage;\n5. Current or probable pregnancy;\n6. Patients with concurrent severe illness likely to influence outcome assessment;\n7. Difficulty in follow-up or poor compliance due to any cause.","ALL","18 Years",{"count":108,"type":109},198,"ESTIMATED","INTERVENTIONAL",[112],"NA","This substudy is a prospective, multicenter, parallel-controlled, randomized controlled trial designed to evaluate whether robot-assisted endoscopic evacuation of large basal ganglia hematomas can improve patient outcomes compared with traditional surgical approaches such as small craniotomy or large-bone-flap intracranial hematoma evacuation.",[115,116],"Hematoma Brain","Large Basal Ganglia Hemorrhage",[116,118,119,120,121,122],"Al-assisted robotic guidance","multicenter","Randomlzed","controlled","umbrella trial","2026-02-12",{"date":125,"type":126},"2026-02-17","ACTUAL",{"date":128,"type":126},"2025-12-20",{"date":130,"type":109},"2027-12-31",{"name":5,"class":6},1]