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Clinical Trials in China / NCT06688162
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Minimally Invasive Soft Channel Brain Haemorrhage Evacuation for Acute Basal Ganglia Haemorrhage--Small Hemorrhage Evacuation (MIRACLE-S)

NCT06688162 · tracked via the Priya Life Science China tracker
Sponsor
Capital Medical University
Phase
Not applicable
Started
2025-01-16
Last updated
2025-01-22

Condition(s) studied

Intracerebral Hemorrhage

Investigational drug(s) / intervention(s)

Usual CareMinimally Invasive Soft Channel Brain Haemorrhage Evacuation (scMIS)

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.

Study 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.

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 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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Capital Medical University Beijing China

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 NCT06688162 on ClinicalTrials.gov ↗ ← All trials in China