Clinical trial NCT06465719: A Multicentre, RAndomlsed, coNtrolled, umBrella Trial fOr Minimally Invasive Neurosurgery With Al-assisted Robotic Guidance for Moderate Basal Ganglia Hemorrhage
Official title: A Multicentre, RAndomlsed, coNtrolled, umBrella Trial fOr Minimally Invasive Neurosurgery With Al-assisted Robotic Guidance for Moderate Basal Ganglia Hemorrhage
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Basal Ganglia Hemorrhage
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
Collaborators: name: Huashan Hospital
name: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
name: China-Japan Friendship Hospital
First posted: 2024-06-20
Enrollment: 312
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Age \> 18
2. Diagnosed with hypertensive basal ganglia hemorrhage (CT, CTA, etc.)
3. Hematoma volume 15 - 30mL
4. With functional impairments (e.g., motor or sensory aphasia, muscle strength ≤ 3 in hemiparetic limbs, or NIHSS ≥ 15)
5. CT shows stable hematoma (a CT scan at least 6 hours after the diagnostic CT, with hematoma volume increase \< 5 ml)
6. Randomized intervention can be initiated within 72 hours
7. Prior mRS ≤1
8. Patients who have Consent

Exclusion Criteria:

1. Hematoma involving the thalamus, midbrain, or other areas
2. Radiologically diagnosed cerebrovascular abnormalities, as well as ischemic infarction converting to intracerebral hemorrhage, or recent (within 1 year) recurrence of intracerebral hemorrhage
3. Brain herniation
4. Any irreversible coagulation disorders or known coagulation system diseases
5. Patients with severe concomitant diseases that may interfere with outcome assessment
6. Pregnancy or possible pregnancy
7. Difficulty in follow-up or potential poor adherence due to various factors

Primary outcomes:
measure: Utility Weighted mRS
timeFrame: 180 days of follow-up
Secondary outcomes:
measure: Ordinal shift of mRS
timeFrame: 180 days of follow-up
measure: Excellent recovery rate
timeFrame: 180 days of follow-up
measure: Independency rate
timeFrame: 180 days of follow-up
measure: Mortality rate
timeFrame: 180 days of follow-up
measure: Activity of daily living (ADL) score prognostic improvement rate (Proportion of patients with ADL≤3)
timeFrame: 180 days of follow-up
measure: Hematoma evacuation rate
timeFrame: 1 day and 30 days after treatment
measure: Duration of hospitalization
timeFrame: 90 days after treatment
measure: Total medical expenses during hospitalization
timeFrame: 6 month after treatment
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: the Second Affiliated Hospital of Zhejiang University School of Medicine
state: Zhejiang
Study officials:
affiliation: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: Gao Chen
role: PRINCIPAL_INVESTIGATOR
References: