Actively Recruiting
Minimally Invasive Soft Channel Brain Hemorrhage Evacuation for Acute Basal Ganglia Hemorrhage Compared to Other Neurosurgical Techniques
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
Researchers are evaluating whether minimally invasive soft channel brain hemorrhage evacuation (scMIS) is at least as effective as other neurosurgical techniques, including open craniotomy, small skull window microsurgery, and endoscopic surgery, for treating acute basal ganglia intracerebral hemorrhage (ICH) with a volume between 30 and 100 ml. The study aims to compare these methods based on the clinical outcome of death or major disability six months after treatment. This trial focuses on patients with reduced consciousness levels and blood pressure below 140 mmHg before randomization. The minimally invasive soft channel technique uses detailed knowledge of brain anatomy to find the best surgical path for catheter insertion. This procedure involves puncture, aspiration, liquefaction using intermittent infusion of medications like urokinase or alteplase, and external drainage to gradually remove the hematoma while reducing brain pressure. The comparison group includes other neurosurgical methods selected by the attending clinician based on hospital expertise and availability. Participants will be monitored for six months after randomization to assess outcomes of death or major disability using the modified Rankin Scale (mRS). The study includes clinical diagnosis confirmation by imaging, informed consent, and blood pressure control before surgery. Researchers will track the effectiveness and safety of the treatments during this period, focusing on recovery and disability levels.
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
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Trial Site Locations
Total: 1 location
1
Linyi People's Hospital
Linyi, Shandong, China, 276000
Actively Recruiting
Research Team
X
XunMing Ji, PhD
H
HeTao Bian, PhD
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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