Tract-based Artificial Intelligence (AI) Robot Guiding System in Basal Ganglion Hemorrhage Evacuation

Basal Ganglia Hemorrhage Clinical Trial

Official title:

Tract-based Artificial Intelligence (AI) Robot Guiding System in Basal Ganglion Hemorrhage Evacuation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06465719
• Other study ID #: IRB-2024-0017
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2025
• Est. completion date: December 31, 2027

Study information

• Verified date: June 2024
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Gao Chen
• Phone: +86 0571-87784813
• Email: d-chengao[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 small-volume basal ganglion hemorrhage.

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 small-volume basal ganglion hemorrhage.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 380
• Est. completion date: December 31, 2027
• Est. primary completion date: December 3, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Diagnosis of spontaneous basal ganglia hemorrhage by imaging (CT, CT angiography, etc.) with a volume between 15 to 30 mL and Glasgow Coma Scale score = 9.

2. With dysfunction such as hematoma-related motor aphasia, sensory aphasia, hemiplegic limb muscle strength = grade 3 or NIHSS score = 15 points.

3. Diagnostic CT scan should be obtained within 24 hours after the onset of symptoms.

4. Hematoma stability shown by a CT scan at least 6 hours after the diagnostic CT (hematoma volume increase < 5 ml)

5. Surgery should be performed within 72 hours after onset.

6. Age between 18-70 years old.

7. Modified Rankin Scale score (mRS) = 1 in past medical history.

8. Patients who are suitable and willing to be randomized to surgery group or conservative medical treatment.

Exclusion Criteria:

1. Hematoma involves other structures such as the thalamus and midbrain.

2. Mass effect or hydrocephalus due to intraventricular hemorrhage.

3. Imaging-based diagnosis of cerebrovascular abnormalities such as ruptured aneurysm, arteriovenous malformation (AVM) and moyamoya disease as well as hemorrhagic transformation of ischemic infarct and recent recurrence (within 1 year) of cerebral hemorrhage.

4. Manifestation of early stage cerebral herniation such as ipsilateral pupil changes and midline shift exceeding 1 cm.

5. Patients with unsteady hematoma or with progression to intracranial hypertension syndrome.

6. Patients with any irreversible coagulopathy or known coagulation disorders; platelet count <100,000; International normalized ratio (INR) > 1.4.

7. Patients requiring long-term use of anticoagulants.

8. Patients taking dabigatran, apixaban and/or rivaroxaban (or similar drugs of the same category) before symptoms arise.

9. Bleeding in other sites, including retroperitoneal, gastrointestinal, genitourinary or respiratory tract bleeding; superficial or skin surface bleeding mainly occurring in the vascular puncture site or transvenous approach (eg. arterial puncture, venous incision, etc. ) or in the recent surgical site.

10. May be pregnant in the near future or already pregnant.

11. Previously enrolled in this study.

12. Participating in other interventional medical research or clinical trials at the same time.

13. Patients with severe co-morbidity (including hepatic, renal, gastrointestinal, respiratory, cardiovascular, endocrine, immune and/or hematological disorders) which may affect the outcome assessment.

14. Patients difficult to follow up or with poor compliance due to various reasons (such as geographical and social factors, drug or alcohol abuse, etc.)

Related Conditions & MeSH terms

• Basal Ganglia Hemorrhage
• Ganglion Cysts
• Hemorrhage

Intervention

Procedure:
• Minimally invasive basal ganglion hematoma evacuation with Tract-based AI Robot Guiding System
Basal ganglion hemorrhage patients will be operated on hematoma puncture and aspiration with Tract-based AI Robot Guiding System

Drug:
• "Hemocoagulase Bothrops Atrox for Injection";"Nicardipine"
Basal ganglion hemorrhage patients will be managed with guideline-based medications without surgery. "Hemocoagulase Bothrops Atrox for Injection" belongs to the drug class of "Hemostatic Agents." "Nicardipine" is a calcium channel blocker (CCB) drug to control blood pressure.

Locations

Country	Name	City	State
China	the Second Affiliated Hospital of Zhejiang University School of Medicine	Hangzhou	Zhejiang

Sponsors (4)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University	China-Japan Friendship Hospital, Huashan Hospital, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prognosis improvement rate (proportion of mRS=3 patients)	Prognosis improvement rate at 6 months of follow-up (proportion of mRS=3 patients)	6 months of follow-up
Secondary	Mortality	Mortality at 6 months of follow-up	6 months of follow-up
Secondary	Activity of daily living (ADL) score prognostic improvement rate (Proportion of patients with ADL=3)	Activity of daily living (ADL) score prognostic improvement rate (Proportion of patients with ADL=3) at 6 months of follow-up	6 months of follow-up
Secondary	Hematoma clearance rate	Hematoma clearance rate at 1 day and 1 month after treatment	1 day and 1 month after treatment
Secondary	Duration of hospitalization	Duration of hospitalization	6 month after treatment
Secondary	Total medical expenses during hospitalization	Total medical expenses during hospitalization	6 month after treatment