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NCT Number: NCT06688201

Minimally Invasive Soft Channel Brain Haemorrhage Evacuation for Acute Basal Ganglia Haemorrhage-- Large Hemorrhage Evacuation (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.

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Key information

Conditions

Intracerebral Hemorrhage Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebral Hemorrhage Cerebrovascular Disorders Hemorrhage Intracranial Hemorrhages Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Linyi People's Hospital

Linyi, Shandong, 276000, China

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • Inclusion Criteria:
  • 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 30 < volume ≤ 100 ml;
  • Reduced level of consciousness (GCS 4-14);
  • Pre-stroke mRS score≤1 points;
  • Systolic blood pressure <140 mmHg before randomisation;
  • Availability of being able to receive either scMIS or other neurosurgical technique;
  • Informed consent obtain accordingly to local regulations.
  • Exclusion Criteria:
  • 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.

Treatment and study plan

Other neurosurgical techniques

Other

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.

Minimally Invasive Soft Channel Brain Haemorrhage Evacuation

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.

Primary outcomes

  1. The primary outcome is death or major disability (mRS scores 0-3) at 6 months.

    Time frame: 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 outcomes

  1. Discharge at Day 7 (yes vs. no)

    Time frame: 7 days after randomization

    Discharge status will be assessed at Day 7

  2. Total length of intensive care unit stay

    Time frame: During hospitalisation up to 6 months after randomization

    The complete length of time a patient is admitted to the intensive care unit (ICU)

  3. Ordinal analysis of modified Rankin Scale [mRS] scores at 28 days

    Time frame: 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.

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

    Time frame: 6-months after randomization

    Proportion of subjects with modified Rankin Scale [mRS] 3-6 at 6 months after randomization.

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

    Time frame: 6-months after randomization

    Modified Rankin Scale [mRS] score at 6 months analysed as an ordinal outcome (categories 3 to 5).

  6. The following at 6-months: ordinal analysis of modified Rankin Scale [mRS] scores 0-6

    Time frame: 6-months after randomization

    Modified Rankin Scale [mRS] score at 6 months analysed as an ordinal outcome (categories 0 to 6).

  7. The following at 6-months: AMC Linear Disability Score(ALDs)

    Time frame: 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.

  8. The following at 6-months: EuroQoL Group 5-Dimension self-report questionnaire (EQ-5D)

    Time frame: 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.

  9. Days of hospitalization

    Time frame: During hospitalisation up to 6 months after randomization

    Length of stay in hospital.

Other outcomes

  1. Safety outcomes

    Time frame: Throughout the entire study period up to 6 months after randomization

    Mortality, rebleeding, infections, and other serious adverse events (SAEs) recorded throughout the entire study period.

Study contacts

Contact information is provided by the study sponsor or research team.

HeTao Bian, PhD

CONTACT

[email protected]

+8618210706812

XunMing Ji, PhD

CONTACT

[email protected]

+8613911077166

Sponsors and collaborators

Lead sponsor

Capital Medical University

Other

Collaborators

  • Fudan University
  • Linyi People's Hospital

Registry information

Acronym: MIRACLE-L

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 14, 2024
Registry last updated
Jan 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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