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

Capital Medical University

Status: Enrolling

Conditions: Intracerebral Hemorrhage

Treatments: Procedure: Minimally Invasive Soft Channel Brain Haemorrhage Evacuation; Other: Other neurosurgical techniques

Study type: Interventional

Funder types: Other

Identifiers

NCT06688201

MIRACLE-L

Details and patient eligibility

About

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.

Enrollment: 550 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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550 participants in 2 patient groups

Other neurosurgical techniques

Other group

Description:

Those include open craniotomy, small skull window microsurgery, and endoscopic surgery.

Treatment:

Other: Other neurosurgical techniques

Minimally Invasive Soft Channel Brain Haemorrhage Evacuation

Experimental group

Description:

Minimally Invasive Soft Channel Brain Haemorrhage Evacuation

Treatment:

Procedure: Minimally Invasive Soft Channel Brain Haemorrhage Evacuation