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

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

Recruiting
18-80 years
All
Phase N/A

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Overview

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.

Eligibility

  • 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:
    10. 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.

    11. A high likelihood that the patient will not adhere to the study treatment and follow-up regimen.
    12. Platelet count < 100,000, INR > 1.4.

Study details
    Intracerebral Hemorrhage

NCT06688201

Capital Medical University

15 January 2025

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