Clinical trial NCT06688201: Minimally Invasive Soft Channel Brain Haemorrhage Evacuation for Acute Basal Ganglia Haemorrhage-- Large Hemorrhage Evacuation (MIRACLE-L)
Official title: Minimally Invasive Soft Channel Brain Haemorrhage Evacuation for Acute Basal Ganglia Haemorrhage-- Large Hemorrhage Evacuation (MIRACLE-L)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Intracerebral Hemorrhage
Lead sponsor: Capital Medical University
Sponsor class: OTHER
Collaborators: name: Linyi People's Hospital
name: Fudan University
First posted: 2024-11-14
Enrollment: 550
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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 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.

Primary outcomes:
measure: The primary outcome is death or major disability (mRS scores 0-3) at 6 months.
timeFrame: 6 months after randomization
Secondary outcomes:
measure: Discharge at Day 7 (yes vs. no)
timeFrame: 7 days after randomization
measure: Total length of intensive care unit stay
timeFrame: During hospitalisation up to 6 months after randomization
measure: Ordinal analysis of modified Rankin Scale [mRS] scores at 28 days
timeFrame: 28 days after randomization
measure: The following at 6-months: ordinal analysis of modified Rankin Scale [mRS] scores 3-6
timeFrame: 6-months after randomization
measure: The following at 6-months: ordinal analysis of modified Rankin Scale [mRS] scores 3-5
timeFrame: 6-months after randomization
measure: The following at 6-months: ordinal analysis of modified Rankin Scale [mRS] scores 0-6
timeFrame: 6-months after randomization
measure: The following at 6-months: AMC Linear Disability Score(ALDs)
timeFrame: 6-months after randomization
measure: The following at 6-months: EuroQoL Group 5-Dimension self-report questionnaire (EQ-5D)
timeFrame: 6-months after randomization
measure: Days of hospitalization
timeFrame: During hospitalisation up to 6 months after randomization
Other outcomes:
measure: Safety outcomes
timeFrame: Throughout the entire study period up to 6 months after randomization
Locations:
city: Linyi
country: China
facility: Linyi People's Hospital
state: Shandong
Study officials:
affiliation: Capital Medical University
name: XunMing Ji, PhD
role: PRINCIPAL_INVESTIGATOR
References: