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

N/AEnrolling By InvitationNCT06688162

Capital Medical University750 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

750

Conditions

Intracerebral Hemorrhage

Interventions

Usual CareOTHER

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)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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

* 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.

Locations (1)

Capital Medical University

Beijing, China

Outcomes

Primary Outcomes

Functional recovery according to UW-mRS assessed at 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.

Time frame: 6 months

Secondary Outcomes

Discharge at Day 7 (yes vs. no)

Discharge status will be assessed at Day 7

Time frame: 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)

Time frame: 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.

Time frame: 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

Time frame: 6-months after randomization

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.