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

Not Applicable

Recruiting

• Conditions: Intracerebral Hemorrhage

• Registration Number: NCT06688201
• Lead Sponsor: Capital Medical University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-10-17
• Study First Submitted QC: 2024-11-12
• Study First Posted: 2024-11-14
• Status Verified: 2025-01
• Study Start: 2025-01-04
• Last Update Submitted: 2025-01-04
• Last Update Posted: 2025-01-07
• Primary Completion: 2026-11-30
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 550

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The primary outcome is death or major disability (mRS scores 0-3) at 6 months.	6 months after randomization	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.

Secondary Outcome Measures

Name	Time	Method
Days of hospitalization	During hospitalisation up to 6 months after randomization	Length of stay in hospital.
Discharge at Day 7 (yes vs. no)	7 days after randomization	Discharge status will be assessed at Day 7
Total length of intensive care unit stay	During hospitalisation up to 6 months after randomization	The complete length of time a patient is admitted to the intensive care unit (ICU)
Ordinal analysis of modified Rankin Scale [mRS] scores at 28 days	28 days after randomization	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.
The following at 6-months: ordinal analysis of modified Rankin Scale [mRS] scores 3-6	6-months after randomization	Proportion of subjects with modified Rankin Scale \[mRS\] 3-6 at 6 months after randomization.
The following at 6-months: ordinal analysis of modified Rankin Scale [mRS] scores 3-5	6-months after randomization	Modified Rankin Scale \[mRS\] score at 6 months analysed as an ordinal outcome (categories 3 to 5).
The following at 6-months: ordinal analysis of modified Rankin Scale [mRS] scores 0-6	6-months after randomization	Modified Rankin Scale \[mRS\] score at 6 months analysed as an ordinal outcome (categories 0 to 6).
The following at 6-months: AMC Linear Disability Score(ALDs)	6-months after randomization	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.
The following at 6-months: EuroQoL Group 5-Dimension self-report questionnaire (EQ-5D)	6-months after randomization	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.

Trial Locations

Locations (1)

Linyi People's Hospital; 🇨🇳 Linyi, Shandong, China