A Multicenter, RAndomlzed, coNtrolled, umBrella Trial fOr Minimally Invasive Neurosurgery With Al-assisted Robotic guidanCe for Hemorrhagic Stroke: Large Basal Ganglia Hemorrhage
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Robot-Assisted Endoscopic Minimally Invasive Surgery, Traditional Surgical Approaches.
- Who it may be relevant to
- Registry conditions: Hematoma Brain, Large Basal Ganglia Hemorrhage. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
This substudy adopts an open-label design, while outcome assessment is performed in a blinded manner. The primary outcome is the modified Rankin Scale (mRS) at 6 months. Outcomes at 30 days, 90 days, and 6 months will also be assessed. Follow-up will be conducted at baseline; 24 hours after surgery/ 30 hours after randomization; 48 hours; Day 3; Day 14 or at discharge; Day 30; Day 90; and Month 6. During follow-up, data will be collected on mortality, survival, ambulation status, living situation, modified Rankin Scale, EQ-5D-5L, Fatigue Severity Scale, AD8, Lawton-Brody Instrumental Activities of Daily Living Scale, National Institutes of Health Stroke Scale (NIHSS), Glasgow Coma Scale, laboratory tests, and neuroimaging findings.
Interventions
- Procedure Robot-Assisted Endoscopic Minimally Invasive Surgery
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. Surgical trajectory: The incision and burr-hole location are determined usi - Procedure Traditional Surgical Approaches
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.
Primary outcome measures
- Modified Rankin Scale (mRS) score at 6 months [Time frame: up to 6 months]
Secondary outcome measures (11)
- Ordinal shift in mRS scores at 6 months (ordinal shift) [Time frame: up to 6 months]
- Favorable functional outcome at 6 months (mRS 0-1) [Time frame: up to 6 months]
- Functional independence at 6 months (mRS 0-2) [Time frame: up to 6 months]
- Health-related quality of life (HRQoL) at 6 months, assessed by the EQ-5D-5L questionnaire [Time frame: up to 6 months]
- Total length of hospital stay [Time frame: up to 6 months]
- Cognitive function at 6 months [Time frame: up to 6 months]
- Hematoma clearance rate at 48 hours postoperatively [Time frame: up to 6 months]
- Costs during hospitalization [Time frame: up to 6 months]
- Intraoperative blood loss [Time frame: up to 6 months]
- Incidence of rebleeding within 14 days [Time frame: up to 6 months]
- Incidence of related complications within 14 days, including pulmonary infection, aphasia, seizures, and deep vein thrombosis of the lower limbs [Time frame: up to 6 months]
Eligibility criteria
Inclusion criteria
- 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;
- Available for surgery within 72 hours after onset;
- Modified Rankin Scale (mRS) score ≤ 1 prior to this hemorrhage;
- Informed consent obtained in accordance with national laws, regulations, and applicable ethics committee requirements.
Exclusion criteria
- 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;
- Current or probable pregnancy;
- Patients with concurrent severe illness likely to influence outcome assessment;
- Difficulty in follow-up or poor compliance due to any cause.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- The Affiliated Drum Tower Hospital of Nanjing University Medical School — Nanjing
Identifiers
NCT: NCT06484374 · SQ2023AAA030147