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;
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