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Intracerebral HemorrhageMIRACLE-SNCT06688162

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

A study testing Minimally Invasive Soft Channel Brain Haemorrhage Evacuation (scMIS) in people with Intracerebral Hemorrhage, run by Capital Medical University at 1 site in China.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Intracerebral Hemorrhage
What is being tested?
Minimally Invasive Soft Channel Brain Haemorrhage Evacuation (scMIS)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
750 participants
Where
1 siteChina
Study dates
16 Jan 2025to 30 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site

  • Capital Medical University

    Beijing

Other trials in China

About this study

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.

Being tested
Usual Care, Minimally Invasive Soft Channel Brain Haemorrhage Evacuation (scMIS)
Medical subject headings
Cerebral Hemorrhage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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 or surgery

    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.

Study groups in NCT06688162
Study groupRoleWhat they receive
Usual CarePlacebo comparatorUsual Care
Receives: Other: Usual Care
Minimally Invasive Soft Channel Brain Haemorrhage Evacuation (scMIS)ExperimentalMinimally Invasive Soft Channel Brain Haemorrhage Evacuation(scMIS)
Receives: Procedure: Minimally Invasive Soft Channel Brain Haemorrhage Evacuation (scMIS)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 6 months

Secondary outcomes (9)

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

    Discharge status will be assessed at Day 7

    Measured: 7 days after randomization

  2. Total length of intensive care unit stay.

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

    Measured: During hospitalisation up to 6 months after randomization

  3. 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.

    Measured: 28 days after randomization

  4. 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

    Measured: 6-months after randomization

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

    Proportion of subjects with modified Rankin Scale [mRS] 3-5 at 6 months after randomization

    Measured: 6-months after randomization

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

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

    Measured: 6-months after randomization

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

    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.

    Measured: 6-months after randomization

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

    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.

    Measured: 6-months after randomization

  9. Days of hospitalization

    Length of stay in hospital

    Measured: During hospitalisation up to 6 months after randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Nov 2024
  2. Study start16 Jan 2025
  3. Primary completion30 Nov 2026 (estimated)
  4. Study completion30 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
750 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06688162
Sponsor's protocol ID
MIRACLE-S
Acronym
MIRACLE-S
Status last verified
Nov 2024
First submitted
17 Oct 2024
Last updated
22 Jan 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Minimally Invasive Soft Channel Brain Haemorrhage Evacuation (scMIS) in people with Intracerebral Hemorrhage, run by Capital Medical University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 22 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Functional recovery according to UW-mRS assessed at 6 months (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06688162.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2025.

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