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Minimally Invasive Soft Channel Brain Haemorrhage Evacuation for Acute Basal Ganglia Haemorrhage--Small Hemorrhage Evacuation (MIRACLE-S)
Sponsor: Capital Medical University
Summary
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.
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
750
Start Date
2025-01-16
Completion Date
2026-12-30
Last Updated
2025-01-22
Healthy Volunteers
No
Conditions
Interventions
Usual Care
During the study treatment and follow-up periods, patients are to receive usual standard of care according to published guidelines for acute stroke care. It is anticipated that background care may include the use of other treatments including drugs and interventions.
Minimally Invasive Soft Channel Brain Haemorrhage Evacuation (scMIS)
This technique is based on the study of hematoma anatomy, cerebral vascular anatomy, and neural fiber structure anatomy in basal ganglia hemorrhage to determine the optimal surgical (catheter insertion) path. By applying stereogeometric principles, it allows for simple yet precise localization. Through surgical steps including puncture, aspiration, liquefaction (intermittent infusion of urokinase or alteplase), and external drainage, the hematoma can be completely removed in stages over a short period. This ensures that hematoma clearance and decompression of the brain occur simultaneously, achieving a minimally invasive intracerebral hemorrhage evacuation technique with a gradual reduction in intracranial pressure.
Locations (1)
Capital Medical University
Beijing, China