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

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

The objective of this study is to determine whether minimally invasive soft channel brain hemorrhage evacuation (scMIS), compared to usual care, leads to superior functional recovery as measured by utility-weighted modified Rankin Scale (UW-mRS) scores at 6 months in patients with basal ganglia intracerebral hemorrhage (ICH) of 20 ≤ volume ≤ 30 ml.

• 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 20 ≤ volume ≤ 30 ml;
  5. Reduced level of consciousness (GCS 9-14);
  6. Pre-stroke mRS score≤1 points;
  7. Systolic blood pressure <140 mmHg before randomisation;
  8. 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.