Actively Recruiting
Minimally Invasive Soft Channel Brain Haemorrhage Evacuation for Acute Basal Ganglia Haemorrhage-- Large Hemorrhage Evacuation (MIRACLE-L)
Led by Capital Medical University · Updated on 2025-01-07
550
Participants Needed
1
Research Sites
103 weeks
Total Duration
On this page
Sponsors
C
Capital Medical University
Lead Sponsor
L
Linyi People's Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Minimally Invasive Soft Channel Brain Haemorrhage Evacuation for Acute Basal Ganglia Haemorrhage-- Large Hemorrhage Evacuation (MIRACLE-L)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 80 years
- Clinical diagnosis of acute intracerebral hemorrhage confirmed by imaging
- Stroke symptoms started within 48 hours and surgery can start within 48 hours
- Basal ganglia hemorrhage with bleeding volume greater than 30 ml and up to 100 ml
- Reduced level of consciousness with Glasgow Coma Scale score between 4 and 14
- Pre-stroke modified Rankin Scale score of 1 or less
- Systolic blood pressure less than 140 mmHg before randomization
- Able to receive either minimally invasive soft channel surgery or other neurosurgical techniques
- Informed consent obtained according to local regulations
You will not qualify if you...
- Intracerebral hemorrhage caused by brain structural abnormalities such as arteriovenous malformation, aneurysm, tumor, trauma, cerebral venous thrombosis, or previous thrombolysis or neurointerventional surgery
- High likelihood of not following the study treatment or follow-up
- Platelet count less than 100,000 or INR greater than 1.4
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Linyi People's Hospital
Linyi, Shandong, China, 276000
Actively Recruiting
Research Team
X
XunMing Ji, PhD
CONTACT
H
HeTao Bian, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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