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

NCT ID: NCT06688162

Last Updated: 2025-01-22

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 750 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-16
• Study Completion Date: 2026-12-30

Brief Summary

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.

Conditions

Intracerebral Hemorrhage

Study Design

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

Study Groups

Usual Care

Usual Care

Group Type: PLACEBO_COMPARATOR

Usual Care

Intervention Type: 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.

Minimally Invasive Soft Channel Brain Haemorrhage Evacuation (scMIS)

Minimally Invasive Soft Channel Brain Haemorrhage Evacuation(scMIS)

Group Type: EXPERIMENTAL

Minimally Invasive Soft Channel Brain Haemorrhage Evacuation (scMIS)

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

Usual Care

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.

Intervention Type: OTHER

Minimally Invasive Soft Channel Brain Haemorrhage Evacuation (scMIS)

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 20 ≤ volume ≤ 30 ml;

5. Reduced level of consciousness (GCS 9-14);

6. Pre-stroke mRS score≤1 points;

7. Systolic blood pressure <140 mmHg before randomisation;

8. 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

Fudan University

OTHER

Sponsor Role: collaborator

Linyi People's Hospital

OTHER

Sponsor Role: collaborator

Capital Medical University

OTHER

Sponsor Role: lead

Responsible Party

Ji Xunming,MD,PhD

President, Head of Neurology, Principal Investigator, Clinical Professor, Xuanwu Hospital of Capital Medical University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

XunMing JI, PhD

Role: PRINCIPAL_INVESTIGATOR

Capital Medical University

Locations

Capital Medical University

Beijing, , China

Countries

China

Other Identifiers

MIRACLE-S

Identifier Type: -

Identifier Source: org_study_id