Robot-guided minimally invasive surgery for large basal ganglia hemorrhage

A Multicenter, RAndomlzed, coNtrolled, umBrella Trial fOr Minimally Invasive Neurosurgery With Al-assisted Robotic guidanCe for Hemorrhagic Stroke: Large Basal Ganglia Hemorrhage

This trial will test whether robot-assisted endoscopic surgery helps adults with large basal ganglia hemorrhages recover better than traditional open surgical approaches.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 198 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School (Academic / other)
• Locations: 1 site (Nanjing)
• Trial ID: NCT06484374 on ClinicalTrials.gov

What this trial studies

This is a multicenter, randomized, parallel-controlled substudy comparing robot-assisted endoscopic hematoma evacuation with traditional small craniotomy or large-bone-flap evacuation for large hypertensive basal ganglia hemorrhages. The surgical design is open-label with blinded outcome assessment and enrolls adults meeting strict imaging and clinical criteria. The primary outcome is the modified Rankin Scale at 6 months, with additional outcome assessments at 30 and 90 days and serial clinical, functional, and imaging measures through six months. Follow-up collects mortality, NIHSS, GCS, EQ-5D-5L, ADL and cognitive scales, lab tests, and neuroimaging to capture safety and functional recovery.

Who should consider this trial

Good fit: Adults (≥18) with hypertensive basal ganglia hematomas ≥30 mL, GCS ≥5, pre-hemorrhage mRS ≤1, able to undergo surgery within 72 hours, and without thalamic/ventricular involvement or vascular abnormalities are the intended candidates.

Not a fit: Patients with significant thalamic or ventricular involvement, confirmed vascular lesions, signs of impending herniation, recent recurrent intracerebral hemorrhage, or preexisting major disability are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, robot-assisted endoscopic evacuation could reduce long-term disability and improve functional recovery compared with traditional open surgery.

How similar studies have performed: Minimally invasive endoscopic evacuation has produced promising but mixed results in prior work, and robot-assisted guidance is a newer approach with limited but encouraging early data.

Eligibility criteria

Inclusion Criteria:

1. Age ≥18 years at randomization;
2. Diagnosed with hypertensive basal ganglia hemorrhage via imaging (CT, CTA, etc.);
3. Hematoma volume ≥30 mL prior to randomization;
4. Glasgow Coma Scale (GCS) score ≥ 5;
5. Available for surgery within 72 hours after onset;
6. Modified Rankin Scale (mRS) score ≤ 1 prior to this hemorrhage;
7. Informed consent obtained in accordance with national laws, regulations, and applicable ethics committee requirements.

Exclusion Criteria:

1. Hematoma involving the thalamus (volume \>5 mL or diameter \>2 cm), midbrain, or ventricles (Graeb score ≥3), or other locations;
2. 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;
3. Signs of impending herniation such as midline shift exceeding 1 cm or ipsilateral pupillary changes;
4. 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;
5. Current or probable pregnancy;
6. Patients with concurrent severe illness likely to influence outcome assessment;
7. Difficulty in follow-up or poor compliance due to any cause.

Where this trial is running

Nanjing

• The Affiliated Drum Tower Hospital of Nanjing University Medical School — Nanjing, China (Recruiting)

Study contacts

• Study coordinator: Chun-Hua Hang, PhD

Conditions Hematoma Brain; Large Basal Ganglia Hemorrhage; Al-assisted robotic guidance; multicenter; Randomlzed; controlled; umbrella trial