Intracerebral HemorrhageMIRACLE-LNCT06688201
Minimally Invasive Soft Channel Brain Haemorrhage Evacuation for Acute Basal Ganglia Haemorrhage-- Large Hemorrhage Evacuation (MIRACLE-L)
A study testing Other neurosurgical techniques and Minimally Invasive Soft Channel Brain Haemorrhage Evacuation in people with Intracerebral Hemorrhage, run by Capital Medical University at 1 site in China.
Trial summary
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… 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?
- Other neurosurgical techniques and Minimally Invasive Soft Channel Brain Haemorrhage Evacuation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 550 participants
- Where
- 1 siteChina
- Study dates
- 4 Jan 2025to 31 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 30 < volume ≤ 100 ml;
- Reduced level of consciousness (GCS 4-14);
- Pre-stroke mRS score≤1 points;
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- 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.
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, 1 recruiting
- Recruiting
Linyi People's Hospital
Linyi, Shandong, 276000
About this study
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.
- Conditions
- Intracerebral Hemorrhage
- Being tested
- Other neurosurgical techniques, Minimally Invasive Soft Channel Brain Haemorrhage Evacuation
- Medical subject headings
- Cerebral Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Other neurosurgical techniquesOther
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 EvacuationProcedure 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 group | Role | What they receive |
|---|---|---|
| Other neurosurgical techniques | Other | Those include open craniotomy, small skull window microsurgery, and endoscopic surgery. Receives: Other: Other neurosurgical techniques |
| Minimally Invasive Soft Channel Brain Haemorrhage Evacuation | Experimental | Minimally Invasive Soft Channel Brain Haemorrhage Evacuation Receives: Procedure: Minimally Invasive Soft Channel Brain Haemorrhage Evacuation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome is death or major disability (mRS scores 0-3) at 6 months.
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: 6 months after randomization
Secondary outcomes (9)
Discharge at Day 7 (yes vs. no)
Discharge status will be assessed at Day 7
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 6-months after randomization
The following at 6-months: ordinal analysis of modified Rankin Scale [mRS] scores 3-5
Modified Rankin Scale [mRS] score at 6 months analysed as an ordinal outcome (categories 3 to 5).
Measured: 6-months after randomization
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
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
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
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.
- First posted14 Nov 2024
- Study start4 Jan 2025
- Primary completion30 Nov 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracerebral HemorrhageStudies of the same condition, open and under way.
- More trials run by Capital Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 550 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Linyi People's Hospital, Fudan University
- Responsible party
- Principal investigator, Ji Xunming,MD,PhD, Capital Medical University
- Investigators
- XunMing Ji, PhD, Principal investigator, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06688201
- Sponsor's protocol ID
- MIRACLE-L
- Acronym
- MIRACLE-L
- Status last verified
- Jan 2025
- First submitted
- 17 Oct 2024
- Last updated
- 7 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimally Invasive Soft Channel Brain Haemorrhage Evacuation for Acute Basal Ganglia Haemorrhage-- Large Hemorrhage Evacuation (MIRACLE-L)
- ClinicalTrials.gov ID
- NCT06688201
- Acronym / sponsor ID
- MIRACLE-L / MIRACLE-L
- Conditions
- Intracerebral Hemorrhage
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 550 participants (estimated)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Collaborators
- Linyi People's Hospital, Fudan University
- Study start
- 4 Jan 2025 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 14 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Other neurosurgical techniques | Other | Other: Other neurosurgical techniquesThose include open craniotomy, small skull window microsurgery, and endoscopic surgery. |
| Minimally Invasive Soft Channel Brain Haemorrhage Evacuation | Experimental | Procedure: Minimally Invasive Soft Channel Brain Haemorrhage EvacuationMinimally Invasive Soft Channel Brain Haemorrhage Evacuation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
Key exclusion criteria (3 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Other neurosurgical techniquesThose 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. | Other | Other neurosurgical techniques |
| Minimally Invasive Soft Channel Brain Haemorrhage EvacuationThis 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. | Procedure or surgery | Minimally Invasive Soft Channel Brain Haemorrhage Evacuation |
Primary outcome
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.
9 secondary outcomes
Discharge at Day 7 (yes vs. no)
Time frame: 7 days after randomization
Total length of intensive care unit stay
Time frame: During hospitalisation up to 6 months after randomization
Ordinal analysis of modified Rankin Scale [mRS] scores at 28 days
Time frame: 28 days after randomization
The following at 6-months: ordinal analysis of modified Rankin Scale [mRS] scores 3-6
Time frame: 6-months after randomization
The following at 6-months: ordinal analysis of modified Rankin Scale [mRS] scores 3-5
Time frame: 6-months after randomization
The following at 6-months: ordinal analysis of modified Rankin Scale [mRS] scores 0-6
Time frame: 6-months after randomization
The following at 6-months: AMC Linear Disability Score(ALDs)
Time frame: 6-months after randomization
The following at 6-months: EuroQoL Group 5-Dimension self-report questionnaire (EQ-5D)
Time frame: 6-months after randomization
Days of hospitalization
Time frame: During hospitalisation up to 6 months after randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
XunMing Ji, PhD principal investigator
Capital Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Other neurosurgical techniques and Minimally Invasive Soft Channel Brain Haemorrhage Evacuation 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 9 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: looking for participants now, as of the sponsor's last update on 7 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. 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?
Contact XunMing Ji, PhD (+8613911077166, jixm@ccmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome is death or major disability (mRS scores 0-3) at 6 months. (time frame: 6 months after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Jan 2025.