NCT06688162

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

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 750 (estimated)
• Sponsor: Capital Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Intracerebral Hemorrhage

Interventions

Type	Name	Description
OTHER	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.
PROCEDURE	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.

Timeline

• Start date: 2025-01-16
• Primary completion: 2026-11-30
• Completion: 2026-12-30
• First posted: 2024-11-14
• Last updated: 2025-01-22

Locations

1 site across 1 country: China