Minimally Invasive Soft Channel Brain Haemorrhage Evacuation for Acute Basal Ganglia Haemorrhage-- Large Hemorrhage Evacuation (MIRACLE-L)

NCT ID: NCT06688201

Last Updated: 2025-01-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 550 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-04
• Study Completion Date: 2026-12-31

Brief Summary

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.

Conditions

Intracerebral Hemorrhage

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Other neurosurgical techniques

Those include open craniotomy, small skull window microsurgery, and endoscopic surgery.

Group Type: OTHER

Other neurosurgical techniques

Intervention Type: 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.

Minimally Invasive Soft Channel Brain Haemorrhage Evacuation

Minimally Invasive Soft Channel Brain Haemorrhage Evacuation

Group Type: EXPERIMENTAL

Minimally Invasive Soft Channel Brain Haemorrhage Evacuation

Intervention Type: 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.

Interventions

Other neurosurgical techniques

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.

Intervention Type: OTHER

Minimally Invasive Soft Channel Brain Haemorrhage Evacuation

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Adults (18 - 80 years) ;

2. The clinical diagnosis is acute intracerebral hemorrhage, confirmed by imaging;

3. Onset within 48 hours, and surgery can be initiated within 48 hours;

4. Basal ganglia hemorrhage, with a bleeding volume of 30 < volume ≤ 100 ml;

5. Reduced level of consciousness (GCS 4-14);

6. Pre-stroke mRS score≤1 points;

7. Systolic blood pressure <140 mmHg before randomisation;

8. Availability of being able to receive either scMIS or other neurosurgical technique;

9. Informed consent obtain accordingly to local regulations.

Exclusion Criteria

1. Definite evidence the ICH is secondary to a structural abnormality in the brain (eg arteriovenous malformation, intracranial aneurysm, tumour, trauma, cerebral venous thrombosis) or previous thrombolysis or neurointerventional surgery.

2. A high likelihood that the patient will not adhere to the study treatment and follow-up regimen.

3. Platelet count < 100,000, INR > 1.4.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Linyi People's Hospital

OTHER

Sponsor Role: collaborator

Fudan University

OTHER

Sponsor Role: collaborator

Capital Medical University

OTHER

Sponsor Role: lead

Responsible Party

Ji Xunming,MD,PhD

Professor ,Beijing Institute of Brain Disorders,Captial Medcial University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

XunMing Ji, PhD

Role: PRINCIPAL_INVESTIGATOR

Capital Medical University

Locations

Linyi People's Hospital

Linyi, Shandong, China

Site Status: RECRUITING

Countries

China

Central Contacts

XunMing Ji, PhD

Role: CONTACT

jixm@ccmu.edu.cn

+8613911077166

HeTao Bian, PhD

Role: CONTACT

hetaobian@163.com

+8618210706812

Other Identifiers

MIRACLE-L

Identifier Type: -

Identifier Source: org_study_id