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

Capital Medical University

Status: Not yet enrolling

Conditions: Intracerebral Hemorrhage

Treatments: Other: Usual Care; Procedure: Minimally Invasive Soft Channel Brain Haemorrhage Evacuation (scMIS)

Study type: Interventional

Funder types: Other

Identifiers

NCT06688162

MIRACLE-S

Details and patient eligibility

About

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.

Enrollment: 750 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 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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750 participants in 2 patient groups, including a placebo group

Usual Care

Placebo Comparator group

Description:

Usual Care

Treatment:

Other: Usual Care

Minimally Invasive Soft Channel Brain Haemorrhage Evacuation (scMIS)

Experimental group

Description:

Minimally Invasive Soft Channel Brain Haemorrhage Evacuation(scMIS)

Treatment:

Procedure: Minimally Invasive Soft Channel Brain Haemorrhage Evacuation (scMIS)