๐ฌIn 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.
๐ Eligibility rules (as published)
Inclusion Criteria:
1. Age โฅ18 years at randomization;
2. Diagnosed with hypertensive basal ganglia hemorrhage via imaging (CT, CTA, etc.);
3. Hematoma volume โฅ30 mL prior to randomization;
4. Glasgow Coma Scale (GCS) score โฅ 5;
5. Available for surgery within 72 hours after onset;
6. Modified Rankin Scale (mRS) score โค 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 โฅ3), 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
The Affiliated Drum Tower Hospital of Nanjing University Medical School
Nanjing, China
๐ค 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.