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Minimally Invasive Soft Channel Brain Haemorrhage Evacuation for Acute Basal Ganglia Haemorrhage-- Large Hemorrhage Evacuation (MIRACLE-L)

RecruitingNAAges 18 Years - 80 YearsAllCapital Medical University
NCT06688201 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

To determine if minimally invasive soft channel brain hemorrhage evacuation (scMIS), compared with any other neurosurgical technique that includes open craniotomy, small skull window microsurgery , and endoscopic surgery, is at least as effective ('not inferior') on poor clinical outcome of death or major disability (mRS scores 4-6) at 6 months in basal ganglia intracerebral hemorrhage (ICH) of 30 \< volume ≤ 100 ml.

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📋 Eligibility rules (as published)
* Inclusion Criteria: 1. Adults (18 - 80 years) ; 2. The clinical diagnosis is acute intracerebral hemorrhage, confirmed by imaging; 3. Onset within 48 hours, and surgery can be initiated within 48 hours; 4. Basal ganglia hemorrhage, with a bleeding volume of 30 \< volume ≤ 100 ml; 5. Reduced level of consciousness (GCS 4-14); 6. Pre-stroke mRS score≤1 points; 7. Systolic blood pressure \<140 mmHg before randomisation; 8. Availability of being able to receive either scMIS or other neurosurgical technique; 9. Informed consent obtain accordingly to local regulations. * Exclusion Criteria: 1. Definite evidence the ICH is secondary to a structural abnormality in the brain (eg arteriovenous malformation, intracranial aneurysm, tumour, trauma, cerebral venous thrombosis) or previous thrombolysis or neurointerventional surgery. 2. A high likelihood that the patient will not adhere to the study treatment and follow-up regimen. 3. Platelet count \< 100,000, INR \> 1.4.
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What it tests

  • Other neurosurgical techniques
  • Minimally Invasive Soft Channel Brain Haemorrhage Evacuation
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Where

1 site
Linyi People's Hospital
Linyi, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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