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

NCT06688162 | Enrolling By Invitation DMC

• 1 other identifier: MIRACLE-S
• Study Type: interventional
• Target: 750
• Locations: 1 country
• Sites: 1

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.

Conditions

Intracerebral Hemorrhage

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

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)

Usual Care

PLACEBO COMPARATOR

Usual Care

Other: Usual Care

Minimally Invasive Soft Channel Brain Haemorrhage Evacuation (scMIS)

EXPERIMENTAL

Minimally Invasive Soft Channel Brain Haemorrhage Evacuation(scMIS)

Procedure: Minimally Invasive Soft Channel Brain Haemorrhage Evacuation (scMIS)

Interventions

Usual Care OTHER

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.

Usual Care

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.

Minimally Invasive Soft Channel Brain Haemorrhage Evacuation (scMIS)

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 20 ≤ volume ≤ 30 ml;
• Reduced level of consciousness (GCS 9-14);
• Pre-stroke mRS score≤1 points;
• Systolic blood pressure \<140 mmHg before randomisation;
• 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
• Fudan University: collaborator
• Linyi People's Hospital: collaborator

Study Sites (1)

Capital Medical University

Beijing, China

Location

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

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: President, Head of Neurology, Principal Investigator, Clinical Professor, Xuanwu Hospital of Capital Medical University

Study Record Dates

• First Submitted: October 17, 2024
• First Posted: November 14, 2024
• Study Start: January 16, 2025
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: January 22, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)