NCT06484374 A Multicenter, RAndomlzed, coNtrolled, umBrella Trial fOr Minimally Invasive Neurosurgery With Al-assisted Robotic guidanCe for Hemorrhagic Stroke: Large Basal Ganglia Hemorrhage
| NCT ID | NCT06484374 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School |
| Condition | Hematoma Brain |
| Study Type | INTERVENTIONAL |
| Enrollment | 198 participants |
| Start Date | 2025-12-20 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 198 participants in total. It began in 2025-12-20 with a primary completion date of 2027-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06484374 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Hematoma Brain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06484374 currently recruiting?
Yes, NCT06484374 is actively recruiting participants. Contact the research team at hang_neurosurgery@163.com for enrollment information.
Where is the NCT06484374 trial being conducted?
This trial is being conducted at Nanjing, China.
Who is sponsoring the NCT06484374 clinical trial?
NCT06484374 is sponsored by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School. The trial plans to enroll 198 participants.