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| Name | Class |
|---|---|
| Fudan University | OTHER |
| Linyi People's Hospital | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care | Placebo Comparator | Usual Care |
|
| Minimally Invasive Soft Channel Brain Haemorrhage Evacuation (scMIS) | Experimental | Minimally Invasive Soft Channel Brain Haemorrhage Evacuation(scMIS) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Usual Care | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Functional recovery according to UW-mRS assessed at 6 months | Utility weighted modified rankin scale scores is to map functional status (modified Rankin Scale [mRS] scores) and health-related quality of life on the European Quality of Life 5-dimensional questionnaire (EQ-5D) to derive utility-weighted (UW) stroke outcome measures. | 6 months |
| 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 | Affiliation | Role |
|---|---|---|
| XunMing JI, PhD | Capital Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Capital Medical University | Beijing | China |
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| Minimally Invasive Soft Channel Brain Haemorrhage Evacuation (scMIS) | 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 | Proportion of subjects with modified Rankin Scale [mRS] 3-5 at 6 months after randomization | 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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