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

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.

Study Overview

• Status: Recruiting
• Conditions: Intracerebral Hemorrhage
• Intervention / Treatment: Other: Other neurosurgical techniques; Procedure: Minimally Invasive Soft Channel Brain Haemorrhage Evacuation

• Study Type: Interventional
• Enrollment (Estimated): 550
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: XunMing Ji, PhD; Phone Number: +8613911077166; Email: jixm@ccmu.edu.cn
• Study Contact Backup: Name: HeTao Bian, PhD; Phone Number: +8618210706812; Email: hetaobian@163.com

Study Locations

• China
  • Shandong
    • Linyi, Shandong, China, 276000
      • Recruiting
      • Linyi People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Other neurosurgical techniques; Those include open craniotomy, small skull window microsurgery, and endoscopic surgery.	Other: 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.
Experimental: Minimally Invasive Soft Channel Brain Haemorrhage Evacuation	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Discharge at Day 7 (yes vs. no)	Discharge status will be assessed at Day 7	7 days after randomization
Total length of intensive care unit stay	The complete length of time a patient is admitted to the intensive care unit (ICU)	During hospitalisation up to 6 months after randomization
Ordinal analysis of modified Rankin Scale [mRS] scores at 28 days	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.	28 days after randomization
The following at 6-months: ordinal analysis of modified Rankin Scale [mRS] scores 3-6	Proportion of subjects with modified Rankin Scale [mRS] 3-6 at 6 months after randomization.	6-months after randomization
The following at 6-months: ordinal analysis of modified Rankin Scale [mRS] scores 3-5	Modified Rankin Scale [mRS] score at 6 months analysed as an ordinal outcome (categories 3 to 5).	6-months after randomization
The following at 6-months: ordinal analysis of modified Rankin Scale [mRS] scores 0-6	Modified Rankin Scale [mRS] score at 6 months analysed as an ordinal outcome (categories 0 to 6).	6-months after randomization
The following at 6-months: AMC Linear Disability Score(ALDs)	The AMC (Academic Medical Center) Linear Disability Score (ALDs) is a calibrated generic item bank designed to measure physical disability levels in patients. The ALDs is a sensitive and generic scale that encompasses a broader range of activities compared to the Rankin assessment. The key distinction between the ALDs and the Rankin assessment is that the ALDs provides a linear disability score based on patient-reported outcomes, while the Rankin score is an ordinal assessment determined by a rater.	6-months after randomization
The following at 6-months: EuroQoL Group 5-Dimension self-report questionnaire (EQ-5D)	An EQ-5D score, also referred to as an EQ-5D value index or utility, quantifies a person's health status on a scale from 1 (full health) to 0 (equivalent to being dead). Negative values may be assigned to health states considered worse than death.The score is calculated using a formula that applies specific weights to each level in the various dimensions of the EQ-5D, with these weights derived from a value set that includes index values for all possible EQ-5D states.	6-months after randomization
Days of hospitalization	Length of stay in hospital.	During hospitalisation up to 6 months after randomization

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety outcomes	Mortality, rebleeding, infections, and other serious adverse events (SAEs) recorded throughout the entire study period.	Throughout the entire study period up to 6 months after randomization

Collaborators and Investigators

• Sponsor: Capital Medical University
• Collaborators: Fudan University; Linyi People's Hospital
• Investigators: Principal Investigator: XunMing Ji, PhD, Capital Medical University

Study record dates

Study Major Dates

• Study Start (Actual): January 4, 2025
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: October 17, 2024
• First Submitted That Met QC Criteria: November 12, 2024
• First Posted (Actual): November 14, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 4, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Basal Ganglia Diseases; Basal Ganglia Cerebrovascular Disease; Hemorrhage; Cerebral Hemorrhage; Intracranial Hemorrhages; Basal Ganglia Hemorrhage
• Other Study ID Numbers: MIRACLE-L

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No