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

Not Applicable

• Conditions: Intracerebral Hemorrhage

• Registration Number: NCT06688162
• Lead Sponsor: Capital Medical University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-10-17
• Status Verified: 2024-11
• Study First Submitted QC: 2024-11-12
• Study First Posted: 2024-11-14
• Study Start: 2025-01-16
• Last Update Submitted: 2025-01-18
• Last Update Posted: 2025-01-22
• Primary Completion: 2026-11-30
• Study Completion: 2026-12-30

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 750

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Functional recovery according to UW-mRS assessed at 6 months	6 months	Utility weighted modified rankin scale scores is to map functional status (modified Rankin Scale \[mRS\] scores) and health-related quality of life on the European Quality of Life 5-dimensional questionnaire (EQ-5D) to derive utility-weighted (UW) stroke outcome measures.

Secondary Outcome Measures

Name	Time	Method
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	Proportion of subjects with modified Rankin Scale \[mRS\] 3-5 at 6 months after randomization
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.
Days of hospitalization	During hospitalisation up to 6 months after randomization	Length of stay in hospital

Trial Locations

Locations (1)

Capital Medical University; 🇨🇳 Bei Jing, China