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Clinical Trials in China / NCT06688201
Recruiting Not applicable

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

NCT06688201 · tracked via the Priya Life Science China tracker
Sponsor
Capital Medical University
Phase
Not applicable
Started
2025-01-04
Last updated
2025-01-07

Condition(s) studied

Intracerebral Hemorrhage

Investigational drug(s) / intervention(s)

Other neurosurgical techniquesMinimally Invasive Soft Channel Brain Haemorrhage Evacuation

Other neurosurgical techniques: Those include open craniotomy, small skull window microsurgery, and endoscopic surgery. The attending clinician is required to consider which type of craniotomy or other procedure according to the expertise and availability at the hospital.

Minimally Invasive Soft Channel Brain Haemorrhage Evacuation: 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.

Study 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

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
* 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 outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Linyi People's Hospital Linyi Shandong Recruiting

More Capital Medical University trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06688201 on ClinicalTrials.gov ↗ ← All trials in China