Robot-guided minimally invasive surgery for large basal ganglia hemorrhage

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

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

Study contacts

• Study coordinator: Chun-Hua Hang, PhD
• Email: hang_neurosurgery@163.com
• Phone: 025-83106666

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.