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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
550
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.
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.
Linyi People's Hospital
Linyi, Shandong, China
RECRUITINGThe primary outcome is death or major disability (mRS scores 0-3) at 6 months.
Ordinal analysis of modified Rankin Scale \[mRS\] score: 0 =No symptoms at all.1 =No significant disability despite symptoms, able to carry out all usual duties and activities.2 =Slight disability, unable to carry out all previous activities but able to look after own affairs without assistance.3 =Moderate disability requiring some help, but able to walk without Assistance. 4 =Moderate severe disability, unable to walk without assistance and unable to attend to own bodily needs without assistance.5 =Severe disability, bedridden incontinent, and requiring constant nursing care and attention.6 =Dead.
Time frame: 6 months after randomization
Discharge at Day 7 (yes vs. no)
Discharge status will be assessed at Day 7
Time frame: 7 days after randomization
Total length of intensive care unit stay
The complete length of time a patient is admitted to the intensive care unit (ICU)
Time frame: During hospitalisation up to 6 months after randomization
Ordinal analysis of modified Rankin Scale [mRS] scores at 28 days
Ordinal analysis of modified Rankin Scale \[mRS\] score: 0 =No symptoms at all.1 =No significant disability despite symptoms, able to carry out all usual duties and activities.2 =Slight disability, unable to carry out all previous activities but able to look after own affairs without assistance.3 =Moderate disability requiring some help, but able to walk without Assistance. 4 =Moderate severe disability, unable to walk without assistance and unable to attend to own bodily needs without assistance.5 =Severe disability, bedridden incontinent, and requiring constant nursing care and attention.6 =Dead.
Time frame: 28 days after randomization
The following at 6-months: ordinal analysis of modified Rankin Scale [mRS] scores 3-6
Proportion of subjects with modified Rankin Scale \[mRS\] 3-6 at 6 months after randomization.
Time frame: 6-months after randomization
The following at 6-months: ordinal analysis of modified Rankin Scale [mRS] scores 3-5
Modified Rankin Scale \[mRS\] score at 6 months analysed as an ordinal outcome (categories 3 to 5).
Time frame: 6-months after randomization
The following at 6-months: ordinal analysis of modified Rankin Scale [mRS] scores 0-6
Modified Rankin Scale \[mRS\] score at 6 months analysed as an ordinal outcome (categories 0 to 6).
Time frame: 6-months after randomization
The following at 6-months: AMC Linear Disability Score(ALDs)
The AMC (Academic Medical Center) Linear Disability Score (ALDs) is a calibrated generic item bank designed to measure physical disability levels in patients. The ALDs is a sensitive and generic scale that encompasses a broader range of activities compared to the Rankin assessment. The key distinction between the ALDs and the Rankin assessment is that the ALDs provides a linear disability score based on patient-reported outcomes, while the Rankin score is an ordinal assessment determined by a rater.
Time frame: 6-months after randomization
The following at 6-months: EuroQoL Group 5-Dimension self-report questionnaire (EQ-5D)
An EQ-5D score, also referred to as an EQ-5D value index or utility, quantifies a person's health status on a scale from 1 (full health) to 0 (equivalent to being dead). Negative values may be assigned to health states considered worse than death.The score is calculated using a formula that applies specific weights to each level in the various dimensions of the EQ-5D, with these weights derived from a value set that includes index values for all possible EQ-5D states.
Time frame: 6-months after randomization
Days of hospitalization
Length of stay in hospital.
Time frame: During hospitalisation up to 6 months after randomization
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