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

NCT06688201 | Recruiting DMC

• 1 other identifier: MIRACLE-L
• Study Type: interventional
• Target: 550
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• The primary outcome is death or major disability (mRS scores 0-3) at 6 months.

  Ordinal analysis of modified Rankin Scale \[mRS\] score: 0 =No symptoms at all.1 =No significant disability despite symptoms, able to carry out all usual duties and activities.2 =Slight disability, unable to carry out all previous activities but able to look after own affairs without assistance.3 =Moderate disability requiring some help, but able to walk without Assistance. 4 =Moderate severe disability, unable to walk without assistance and unable to attend to own bodily needs without assistance.5 =Severe disability, bedridden incontinent, and requiring constant nursing care and attention.6 =Dead.

  6 months after randomization

Secondary Outcomes (9)

• Discharge at Day 7 (yes vs. no)

  7 days after randomization

• Total length of intensive care unit stay

  During hospitalisation up to 6 months after randomization

• Ordinal analysis of modified Rankin Scale [mRS] scores at 28 days

  28 days after randomization

• The following at 6-months: ordinal analysis of modified Rankin Scale [mRS] scores 3-6

  6-months after randomization

• The following at 6-months: ordinal analysis of modified Rankin Scale [mRS] scores 3-5

  6-months after randomization

Other Outcomes (1)

• Safety outcomes

  Throughout the entire study period up to 6 months after randomization

Study Arms (2)

Other neurosurgical techniques

OTHER

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

Other: Other neurosurgical techniques

Minimally Invasive Soft Channel Brain Haemorrhage Evacuation

EXPERIMENTAL

Minimally Invasive Soft Channel Brain Haemorrhage Evacuation

Procedure: Minimally Invasive Soft Channel Brain Haemorrhage Evacuation

Interventions

Other neurosurgical techniques 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.

Other neurosurgical techniques

Minimally Invasive Soft Channel Brain Haemorrhage Evacuation 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.

Minimally Invasive Soft Channel Brain Haemorrhage Evacuation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults (18 - 80 years) ;
• The clinical diagnosis is acute intracerebral hemorrhage, confirmed by imaging;
• Onset within 48 hours, and surgery can be initiated within 48 hours;
• Basal ganglia hemorrhage, with a bleeding volume of 30 \< volume ≤ 100 ml;
• Reduced level of consciousness (GCS 4-14);
• Pre-stroke mRS score≤1 points;
• Systolic blood pressure \<140 mmHg before randomisation;
• Availability of being able to receive either scMIS or other neurosurgical technique;
• Informed consent obtain accordingly to local regulations.

You may not qualify if:

• 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.
• A high likelihood that the patient will not adhere to the study treatment and follow-up regimen.
• Platelet count \< 100,000, INR \> 1.4.

Sponsors & Collaborators

• Capital Medical University: lead
• Linyi People's Hospital: collaborator
• Fudan University: collaborator

Study Sites (1)

Linyi People's Hospital

Linyi, Shandong, 276000, China

RECRUITING

MeSH Terms

Conditions

Cerebral Hemorrhage

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• XunMing Ji, PhD

  Capital Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

XunMing Ji, PhD

CONTACT

+8613911077166; jixm@ccmu.edu.cn

HeTao Bian, PhD

CONTACT

+8618210706812; hetaobian@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor ,Beijing Institute of Brain Disorders,Captial Medcial University

Study Record Dates

• First Submitted: October 17, 2024
• First Posted: November 14, 2024
• Study Start: January 4, 2025
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 7, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)