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| Name | Class |
|---|---|
| Linyi People's Hospital | OTHER |
| Fudan University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Other neurosurgical techniques | Other | Those include open craniotomy, small skull window microsurgery, and endoscopic surgery. |
|
| Minimally Invasive Soft Channel Brain Haemorrhage Evacuation | Experimental | Minimally Invasive Soft Channel Brain Haemorrhage Evacuation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Other neurosurgical techniques | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The 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. | 6 months after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Discharge at Day 7 (yes vs. no) | Discharge status will be assessed at Day 7 | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Safety outcomes | Mortality, rebleeding, infections, and other serious adverse events (SAEs) recorded throughout the entire study period. | Throughout the entire study period up to 6 months after randomization |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| XunMing Ji, PhD | Contact | +8613911077166 | jixm@ccmu.edu.cn | |
| HeTao Bian, PhD | Contact | +8618210706812 | hetaobian@163.com |
| Name | Affiliation | Role |
|---|---|---|
| XunMing Ji, PhD | Capital Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Linyi People's Hospital | Recruiting | Linyi | Shandong | 276000 | China |
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| Minimally Invasive Soft Channel Brain Haemorrhage Evacuation | Procedure | 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. |
|
| 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. | 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. | 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). | 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). | 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. | 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. | 6-months after randomization |
| Days of hospitalization | Length of stay in hospital. | During hospitalisation up to 6 months after randomization |
| ID | Term |
|---|---|
| D002543 | Cerebral Hemorrhage |
| ID | Term |
|---|---|
| D020300 | Intracranial Hemorrhages |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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