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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

RecruitingNAAges 18 Years - anyAllThe Affiliated Nanjing Drum Tower Hospital of Nanโ€ฆ
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Age โ‰ฅ18 years at randomization; 2. Diagnosed with hypertensive basal ganglia hemorrhage via imaging (CT, CTA, etc.); 3. Hematoma volume โ‰ฅ30 mL prior to randomization; 4. Glasgow Coma Scale (GCS) score โ‰ฅ 5; 5. Available for surgery within 72 hours after onset; 6. Modified Rankin Scale (mRS) score โ‰ค 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 โ‰ฅ3), 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.
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What it tests

  • Robot-Assisted Endoscopic Minimally Invasive Surgery
  • Traditional Surgical Approaches
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Where

1 site
The Affiliated Drum Tower Hospital of Nanjing University Medical School
Nanjing, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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