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| Name | Class |
|---|---|
| Huashan Hospital | OTHER |
| The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | OTHER |
| China-Japan Friendship Hospital | OTHER |
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A nationwide, prospective, multicenter randomized controlled clinical trial to evaluate the therapeutic effects of the fiber tract-based artificial intelligence (AI) Robot Guiding System on the perioperative and long-term recovery of patients with moderate-volume basal ganglion hemorrhage.
Basal ganglion hemorrhage is one of the most common subtypes of cerebral hemorrhage, characterized by high morbidity, mortality, and disability rates. Minimally invasive surgery for cerebral hemorrhage, particularly utilizing a fiber tract-based AI Robot Guiding System, has shown potential advantages for patient prognosis. However, there is currently no standardized practice or robust evidence confirming the effectiveness and safety of this technology for small-volume basal ganglion hemorrhage. Therefore, we are conducting a nationwide, prospective, multicenter randomized controlled clinical trial to evaluate the therapeutic effects of the fiber tract-based artificial intelligence (AI) Robot Guiding System on the perioperative and long-term recovery of patients with moderate-volume basal ganglion hemorrhage.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tract-based AI Robot Guiding System Group | Experimental | Patients will be operated on minimally invasive puncture and aspiration using Tract-based AI Robot guidance System |
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| Conservative Group | Sham Comparator | Patients will be managed with guideline-based medications without surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Minimally invasive basal ganglion hematoma evacuation with Tract-based AI Robot Guiding System | Procedure | Basal ganglion hemorrhage patients will be operated on hematoma puncture and aspiration with Tract-based AI Robot Guiding System |
| Measure | Description | Time Frame |
|---|---|---|
| Utility-weighted modified Rankin Scale (UW-mRS) | The mRS is a 7-level ordinal scale used to evaluate functional outcomes after stroke. The categories are defined as follows: 0 = No symptomsï¼›
| 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Ordinal shift in modified Rankin Scale | Ordinal shift analysis of the modified Rankin Scale (mRS), which measures the degree of disability or dependence in daily activities after stroke. The scale ranges from 0 (no symptoms) to 6 (death). This outcome assesses whether there is a shift toward better or worse functional status across the full ordinal distribution of mRS scores. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | Mortality status equals to death which will be collected at all visits during the trial period | 6 months |
| Serious Adverse Events (SAEs) | The reporting and notification of SAEs follows ICH-GCP guidelines. According to the WHO International Drug Monitoring Centre (1994), an SAE is any adverse medical event that: Leading to death; Life-threatening; Requires hospitalization or prolongs existing hospitalization; Results in persistent or significant disability/incapacity; Congenital anomaly/birth defect; etc. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gao Chen | Contact | +86 0571-87784813 | d-chengao@zju.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Gao Chen | Second Affiliated Hospital, School of Medicine, Zhejiang University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the Second Affiliated Hospital of Zhejiang University School of Medicine | Recruiting | Hangzhou | Zhejiang | 310009 | China |
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| Label | URL |
|---|---|
| A Multicenter, Randomized, Controlled, Umbrella Trial for Minimally Invasive Neurosurgery With Al-assisted Robotic Guidance for Hemorrhagic Stroke (RAINBOW-ICH) | View source |
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Patients will be randomly assigned to treatment or conservative group, so masking is only for outcome assessors
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| Patients will be managed with guideline-based medications | Drug | Patients will be managed with guideline-based medications without surgery |
|
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| Excellent functional neurological outcome | Excellent functional neurological outcome means modified Rankin scale (mRS) scores 0-1. The minimum mRS is 0 (no symptoms) while the maximum mRS is 6 (death). The higher the mRS score is the worse outcome is. | 6 months |
| Independent functional neurological outcome | Independent functional neurological outcome means modified Rankin scale (mRS) scores 0-2. The minimum mRS is 0 (no symptoms) while the maximum mRS is 6 (death). The higher the mRS score is the worse outcome is. | 6 months |
| Health Related Quality of Life | Health Related Quality of Life based on EuroQol 5 Dimension 5 Level (EQ-5D-5L).The EQ-5D-5L is a generic instrument for describing and valuing health. It assesses five domains: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension has five response categories corresponding to: no problems, slight, moderate, severe and extreme problems. | 6 months |
| Total length of hospital stay | Total length of hospital stay refers to the number of days from the date of hospital admission to the date of discharge. | 6 months |
| AD8 Dementia Screening | The AD8 (Eight-item Interview to Differentiate Aging and Dementia) is a brief screening tool designed to distinguish normal aging from possible dementia. The AD8 focuses on changes in memory, orientation, judgment, and daily activities. A greater number of "Yes" responses indicates higher likelihood of cognitive impairment or dementia, warranting further diagnostic evaluation. | 6 months |
| Hematoma evacuation rate | Hematoma clearance rate at Day1 and Day30 after treatment | 30 days after treatment |
| Total medical expenses during hospitalization | Total medical expenses during hospitalization | 6 month |
| 6 months |
| ID | Term |
|---|---|
| D020145 | Basal Ganglia Hemorrhage |
| ID | Term |
|---|---|
| D020144 | Basal Ganglia Cerebrovascular Disease |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D002561 | Cerebrovascular Disorders |
| D002543 | Cerebral Hemorrhage |
| D020300 | Intracranial Hemorrhages |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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