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.
Age ≥18 years at randomization;
Diagnosed with hypertensive basal ganglia hemorrhage via imaging (CT, CTA, etc.);
Hematoma volume ≥30 mL prior to randomization;
Glasgow Coma Scale (GCS) score ≥ 5;
Hematoma involving the thalamus (volume >5 mL or diameter >2 cm), midbrain, or ventricles (Graeb score ≥3), or other locations;
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;
Signs of impending herniation such as midline shift exceeding 1 cm or ipsilateral pupillary changes;
Any irreversible coagulation disorder or known coagulopathy; platelet count <100,000; INR >1.4; or use of anticoagulant medication within 7 days before the current hemorrhage;
Parallel
Robot-Assisted Endoscopic Minimally Invasive Surgery
Procedure/SurgeryNeurosurgeons 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. Surgical 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. Plan review by supporting units: All preoperative imaging data and trajectory plans are automatically stored and uploaded b
Traditional Surgical Approaches
Procedure/SurgeryA 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.
Modified Rankin Scale (mRS) score at 6 months
The primary analysis will compare differences between the two groups based on utility-weighted mRS.
Ordinal shift in mRS scores at 6 months (ordinal shift)
The difference in the distribution of scores on the modified Rankin Scale (mRS, range 0-6) between the treatment and control groups was assessed at 6 months after onset (or treatment) using a shift analysis.
Favorable functional outcome at 6 months (mRS 0-1)
The proportion of patients achieving an excellent functional outcome (defined as mRS score of 0 or 1) at 6 months.
Functional independence at 6 months (mRS 0-2)
The proportion of patients achieving functional independence (defined as mRS score of 0, 1, 2) at 6 months.
Health-related quality of life (HRQoL) at 6 months, assessed by the EQ-5D-5L questionnaire
Assessed using the EQ-5D-5L questionnaire at 6 months post-onset/post-surgery. The instrument comprises five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) with five levels of severity, plus a Visual Analogue Scale (EQ-VAS)
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The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Lead sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborator
Affiliated Hospital of Nantong University
Collaborator
The First People's Hospital of Lianyungang
Collaborator
Huashan Hospital
Collaborator
China-Japan Friendship Hospital
Collaborator
The First Affiliated Hospital of Zhengzhou University
Collaborator
Second Affiliated Hospital of Xi'an Jiaotong University
Collaborator
Shaoxing Central Hospital
Collaborator
Jinhua Central Hospital
Collaborator
The Second Affiliated Hospital of Kunming Medical University
Collaborator
First Affiliated Hospital of Guangxi Medical University
Collaborator
First Affiliated Hospital of Chongqing Medical University
Collaborator
Shanghai East Hospital
Collaborator
The First Affiliated Hospital of Anhui Medical University
Collaborator
Renmin Hospital of Wuhan University
Collaborator
The First Affiliated Hospital of Nanchang University
Collaborator
Aerospace Center Hospital
Collaborator
Hebei General Hospital
Collaborator
First Affiliated Hospital of Harbin Medical University
Collaborator
The Affiliated Hospital of Inner Mongolia Medical University
Collaborator
Jinshan Hospital Fudan University
Collaborator
Minhang District Central Hospital of Shanghai
Collaborator
