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

RECRUITINGNA

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

NCT06484374•The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.

Locations (1)

The Affiliated Drum Tower Hospital of Nanjing University Medical School

Nanjing, China

Key Dates

Start Date

December 20, 2025

Primary Completion Date

June 30, 2027

Completion Date

December 31, 2027

Last Updated

February 17, 2026

Enrollment

198

ESTIMATED participants

Conditions

Hematoma BrainLarge Basal Ganglia Hemorrhage

Interventions

Robot-Assisted Endoscopic Minimally Invasive Surgery

PROCEDURE

Traditional Surgical Approaches

PROCEDURE

Contacts

Chun-Hua Hang, PhD

CONTACT

025-83106666 hang_neurosurgery@163.com