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Basal Ganglia HemorrhageRAINBOW-ICHNCT07205263

RAINBOW-ICH Trial of AI Guided Minimally Invasive Neurosurgery for ICH

A study testing AI-assisted robotic-guided endoscopic hematoma evacuation, Conventional craniotomy and AI-assisted robotic-guided puncture and hematoma evacuation in people with Basal Ganglia Hemorrhage and Intraventricular Hemorrhage, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Intracerebral hemorrhage (ICH) is one of the most devastating forms of stroke, with high rates of death and disability worldwide. Despite advances in medical and surgical care, effective therapeutic options remain limited. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
AI-assisted robotic-guided endoscopic hematoma evacuation, Conventional craniotomy and AI-assisted robotic-guided puncture and hematoma evacuation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,000 participants
Where
1 siteChina
Study dates
30 Sep 2025to Dec 2027
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Umbrella Trial Inclusion Criteria:

  1. Age ≥18 years;
  2. Clinical diagnosis of spontaneous hemorrhagic stroke;

Umbrella Trial Exclusion Criteria:

  1. Radiologically diagnosed cerebrovascular abnormalities, as well as ischemic infarction converting to intracerebral hemorrhage, or recent (within 1 year) recurrence of intracerebral hemorrhage;

Each substudy will specify additional inclusion and exclusion criteria in the respective Substudy-specific Registration. Patients who fulfill the overall umbrella trial criteria will be assessed for enrollment into each substudy.

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
  • The Second Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310000

    Recruiting

Other trials in China

About this study

Official title: A Multicenter, Randomized, Controlled, Umbrella Trial for Minimally Invasive Neurosurgery With Al-assisted Robotic Guidance for Hemorrhagic Stroke (RAINBOW-ICH)

Intracerebral hemorrhage (ICH) is one of the most devastating forms of stroke, with high rates of death and disability worldwide. Despite advances in medical and surgical care, effective therapeutic options remain limited. To address this gap, the RAINBOW-ICH trial has been designed as a nationwide, multicenter, randomized umbrella trial evaluating the efficacy and safety of AI-assisted, robotic-guided minimally invasive neurosurgery compared with conventional strategies across major ICH subtypes.

Under a single master protocol, RAINBOW-ICH incorporates multiple parallel randomized controlled substudies, each targeting a distinct ICH population-large basal ganglia hemorrhage, moderate basal ganglia hemorrhage, intraventricular hemorrhage, and brainstem hemorrhage. This umbrella design allows efficient use of resources while generating high-quality evidence tailored to the specific needs of different ICH subgroups, thereby supporting a more patient-centered approach to care.

Read the detailed description

Intracerebral hemorrhage (ICH) is a leading cause of stroke-related mortality and long-term disability worldwide. Conventional surgical techniques, including craniotomy and catheter-based drainage, are often associated with significant procedural risks and variable outcomes across clinical settings. Minimally invasive approaches have been proposed to reduce surgical trauma, improve precision, and enhance recovery. Recent studies, such as the ENRICH trial, have provided encouraging evidence that selected patients may benefit from early minimally invasive hematoma evacuation, though results remain heterogeneous and further validation is needed across different ICH subtypes and populations.

The RAINBOW-ICH trial has been established to address this critical gap by systematically evaluating the role of AI-assisted, robotic-guided minimally invasive neurosurgery. Advances in robotics and artificial intelligence have enabled neurosurgeons to achieve greater precision in hematoma evacuation, minimize surgical injury, and improve reproducibility of complex procedures. RAINBOW-ICH is designed as a nationwide, multicenter umbrella trial, conducted under a single master protocol, with multiple parallel randomized controlled substudies. Each substudy focuses on a distinct ICH population and directly compares AI-assisted robotic-guided hematoma evacuation with the conventional standard of care relevant to that subgroup. Specifically, RAINBOW-LBH (NCT06484374) evaluates patients with large basal ganglia hemorrhage, RAINBOW-MBH (NCT06465719) addresses moderate basal ganglia hemorrhage, RAINBOW-IVH (NCT06486480) investigates intraventricular hemorrhage, and RAINBOW-BSH (NCT06459427) targets brainstem hemorrhage.

Within each substudy, participants are randomized to receive either AI-assisted robotic-guided minimally invasive neurosurgery or the control intervention, such as conventional craniotomy, external ventricular drainage, or optimized medical management. All substudies are conducted as multicenter RCTs across China, ensuring adequate and rapid recruitment, generalizability, and rigorous evaluation of interventions in diverse clinical environments.

By integrating minimally invasive neurosurgical technologies with a unified multicenter umbrella trial design, RAINBOW-ICH represents the first large-scale effort in China to rigorously test and compare surgical strategies for ICH. The findings are expected to generate high-quality evidence, refine clinical practice, and ultimately improve neurological outcomes for patients with this devastating disease.

Being tested
AI-assisted robotic-guided endoscopic hematoma evacuation, Conventional craniotomy, AI-assisted robotic-guided puncture and hematoma evacuation, Standard medical management, AI-assisted robotic-guided endoscopic ventricular hematoma evacuation plus external ventricular drainage
Keywords
Umbrella Trial, Intraventricular hemorrhage, Brainstem Stroke, Robotic-guided, Basal Ganglia Hemorrhage, Minimally invasive surgery
Medical subject headings
Basal Ganglia Hemorrhage, Brain Stem Infarctions, Intracranial Hemorrhages

What participants receive

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

  • AI-assisted robotic-guided endoscopic hematoma evacuationProcedure or surgery

    Surgical removal of hematoma using AI-assisted robotic-guided stereotactic navigation and endoscopic aspiration techniques.

  • Conventional craniotomyProcedure or surgery

    Standard open surgical evacuation of hematoma through craniotomy.

  • AI-assisted robotic-guided puncture and hematoma evacuationProcedure or surgery

    AI-assisted robotic-guided stereotactic puncture and aspiration of hematoma.

  • Standard medical managementOther

    Guideline-based conservative therapy without surgical hematoma evacuation.

  • AI-assisted robotic-guided endoscopic ventricular hematoma evacuation plus external ventricular drainageProcedure or surgery

    AI-assisted robotic-guided endoscopic evacuation of ventricular hematoma combined with external ventricular drainage.

  • External ventricular drainage (EVD)Procedure or surgery

    Conventional ventricular catheter placement for hematoma drainage.

Study groups in NCT07205263
Study groupRoleWhat they receive
RAINBOW-LBH substudyExperimentalThis substudy is a prospective, multicenter, randomized, controlled, parallel-group trial with blinded endpoint assessment to evaluate the efficacy and safety of AI-assisted robotic-guided endoscopic hematoma evacuation for patients with large basal ganglia hemorrhage (LBH).
Receives: Procedure: AI-assisted robotic-guided endoscopic hematoma evacuation; Procedure: Conventional craniotomy
RAINBOW-MBH substudyExperimentalThis substudy is a prospective, multicenter, randomized, controlled, parallel-group trial with blinded endpoint assessment to evaluate AI-assisted robotic-guided puncture and hematoma evacuation for patients with moderate basal ganglia hemorrhage (MBH).
Receives: Procedure: AI-assisted robotic-guided puncture and hematoma evacuation; Other: Standard medical management
RAINBOW-IVH substudyExperimentalThis substudy is a prospective, multicenter, randomized, controlled, parallel-group trial with blinded endpoint assessment to evaluate AI-assisted robotic-guided endoscopic ventricular hematoma evacuation with external ventricular drainage for patients with intraventricular hemorrhage (IVH)
Receives: Procedure: AI-assisted robotic-guided endoscopic ventricular hematoma evacuation plus external ventricular drainage; Procedure: External ventricular drainage (EVD)
RAINBOW-BSH substudyExperimentalThis substudy is a prospective, multicenter, randomized, controlled, parallel-group trial with blinded endpoint assessment to evaluate AI-assisted robotic-guided puncture and hematoma evacuation for patients with brainstem hemorrhage (BSH).
Receives: Procedure: AI-assisted robotic-guided puncture and hematoma evacuation; Other: Standard medical management

What is being measured

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

  1. Utility-weighted modified Rankin Scale (UW-mRS)

    The mRS is a 7-level ordinal scale used to evaluate functional outcomes after stroke. The categories are defined as follows:

    0 = No symptoms

    1. = No significant disability. Able to carry out all usual activities, despite some symptoms.
    2. = Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
    3. = Moderate disability. Requires some help, but able to walk unassisted.
    4. = Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.
    5. = Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
    6. = Dead Utility-weighted modified Rankin Scale (UW-mRS) , which applies utility values to each mRS category as shown below: mRS 0= UW-mRS 1;mRS 1= UW-mRS 0.91; mRS 2= UW-mRS 0.76; mRS 3= UW-mRS 0.65; mRS 4= UW-mRS 0.33; mRS 5= UW-mRS 0; mRS 6= UW-mRS 0.

    Measured: Umbrella level time frame: 6 months; Substudy specific time frame may differ (details will be included in substudy-specific registration)

Secondary outcomes (5)
  1. Ordinal shift in modified Rankin Scale

    Ordinal shift analysis of the modified Rankin Scale (mRS), which measures the degree of disability or dependence in daily activities after stroke. The scale ranges from 0 (no symptoms) to 6 (death). This outcome assesses whether there is a shift toward better or worse functional status across the full ordinal distribution of mRS scores.

    Measured: Umbrella level time frame: 6 months; Substudy specific time frame may differ (details will be included in substudy-specific registration)

  2. Excellent functional neurological outcome

    Excellent functional neurological outcome means modified Rankin scale (mRS) scores 0-1. The minimum mRS is 0 (no symptoms) while the maximum mRS is 6 (death). The higher the mRS score is the worse outcome is.

    Measured: Umbrella level time frame: 6 months; Substudy specific time frame may differ (details will be included in substudy-specific registration)

  3. Independent functional neurological outcome

    Independent functional neurological outcome means modified Rankin scale (mRS) scores 0-2. The minimum mRS is 0 (no symptoms) while the maximum mRS is 6 (death). The higher the mRS score is the worse outcome is.

    Measured: Umbrella level time frame: 6 months; Substudy specific time frame may differ (details will be included in substudy-specific registration)

  4. Health Related Quality of Life

    Health Related Quality of Life based on EuroQol 5 Dimension 5 Level (EQ-5D-5L).The EQ-5D-5L is a generic instrument for describing and valuing health. It assesses five domains: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension has five response categories corresponding to: no problems, slight, moderate, severe and extreme problems.

    Measured: Umbrella level time frame: 6 months; Substudy specific time frame may differ (details will be included in substudy-specific registration)

  5. Total length of hospital stay

    Total length of hospital stay refers to the number of days from the date of hospital admission to the date of discharge.

    Measured: Umbrella level time frame: 6 months; Substudy specific time frame may differ (details will be included in substudy-specific registration)

Timeline

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

  1. First posted3 Oct 2025
  2. Study start30 Sep 2025
  3. Primary completionDec 2027 (estimated)
  4. Study completionDec 2027 (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
1,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07205263
Sponsor's protocol ID
2023ZD0505000
Acronym
RAINBOW-ICH
Status last verified
Aug 2025
First submitted
25 Sep 2025
Last updated
8 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing AI-assisted robotic-guided endoscopic hematoma evacuation, Conventional craniotomy and AI-assisted robotic-guided puncture and hematoma evacuation in people with Basal Ganglia Hemorrhage and Intraventricular Hemorrhage, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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?

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 8 Jan 2026. 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 Gao Chen, MD. (+86 0571 87784813, d-chengao@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Utility-weighted modified Rankin Scale (UW-mRS) (time frame: Umbrella level time frame: 6 months; Substudy specific time frame may differ (details will be included in substudy-specific registration)). 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 8 Jan 2026.

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