Hematoma BrainRAINBOW-LBHNCT06484374
A Multicenter, RAndomlzed, coNtrolled, umBrella Trial fOr Minimally Invasive Neurosurgery With Al-assisted Robotic guidanCe for Hemorrhagic Stroke: Large Basal Ganglia Hemorrhage
A study testing Robot-Assisted Endoscopic Minimally Invasive Surgery and Traditional Surgical Approaches in people with Hematoma Brain and Large Basal Ganglia Hemorrhage, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.
Trial summary
This substudy is a prospective, multicenter, parallel-controlled, randomized controlled trial designed to evaluate whether robot-assisted endoscopic evacuation of large basal ganglia hematomas can improve patient outcomes compared with traditional surgical approaches such as small craniotomy or large-bone-flap… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematoma Brain, Large Basal Ganglia Hemorrhage
- What is being tested?
- Robot-Assisted Endoscopic Minimally Invasive Surgery and Traditional Surgical Approaches
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 198 participants
- Where
- 1 siteChina
- Study dates
- 20 Dec 2025to 31 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
Who may be able to join
- Age ≥18 years at randomization;
- Diagnosed with hypertensive basal ganglia hemorrhage via imaging (CT, CTA, etc.);
- Hematoma volume ≥30 mL prior to randomization;
- Glasgow Coma Scale (GCS) score ≥ 5;
- Available for surgery within 72 hours after onset;
- Modified Rankin Scale (mRS) score ≤ 1 prior to this hemorrhage;
- Informed consent obtained in accordance with national laws, regulations, and applicable ethics committee requirements.
Who cannot join
- Hematoma involving the thalamus (volume >5 mL or diameter >2 cm), midbrain, or ventricles (Graeb score ≥3), or other locations;
- Radiologically confirmed cerebral vascular abnormalities including ruptured aneurysms, arteriovenous malformations (AVMs), or Moyamoya disease; hemorrhagic transformation of ischemic infarcts; or recent (within 1 year) recurrence of intracerebral hemorrhage;
- Signs of impending herniation such as midline shift exceeding 1 cm or ipsilateral pupillary changes;
- Any irreversible coagulation disorder or known coagulopathy; platelet count <100,000; INR >1.4; or use of anticoagulant medication within 7 days before the current hemorrhage;
- Current or probable pregnancy;
- Patients with concurrent severe illness likely to influence outcome assessment;
- Difficulty in follow-up or poor compliance due to any cause.
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
The Affiliated Drum Tower Hospital of Nanjing University Medical School
Nanjing
Chunhua Hang, 025-83106666, hang_neurosurgery@163.com
About this study
This substudy is a prospective, multicenter, parallel-controlled, randomized controlled trial designed to evaluate whether robot-assisted endoscopic evacuation of large basal ganglia hematomas can improve patient outcomes compared with traditional surgical approaches such as small craniotomy or large-bone-flap intracranial hematoma evacuation.
Read the detailed description
This substudy adopts an open-label design, while outcome assessment is performed in a blinded manner. The primary outcome is the modified Rankin Scale (mRS) at 6 months. Outcomes at 30 days, 90 days, and 6 months will also be assessed. Follow-up will be conducted at baseline; 24 hours after surgery/ 30 hours after randomization; 48 hours; Day 3; Day 14 or at discharge; Day 30; Day 90; and Month 6. During follow-up, data will be collected on mortality, survival, ambulation status, living situation, modified Rankin Scale, EQ-5D-5L, Fatigue Severity Scale, AD8, Lawton-Brody Instrumental Activities of Daily Living Scale, National Institutes of Health Stroke Scale (NIHSS), Glasgow Coma Scale, laboratory tests, and neuroimaging findings.
- Conditions
- Hematoma Brain, Large Basal Ganglia Hemorrhage
- Being tested
- Robot-Assisted Endoscopic Minimally Invasive Surgery, Traditional Surgical Approaches
- Keywords
- Large Basal Ganglia Hemorrhage, Al-assisted robotic guidance, multicenter, Randomlzed, controlled, umbrella trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robot-Assisted Endoscopic Minimally Invasive SurgeryProcedure or surgery
Neurosurgeons participating in the robot-assisted endoscopic procedure must be qualified doctors who have completed standardized training and certification by the coordinating center. They must be capable of performing endoscopic hematoma evacuation and managing common intraoperative complications. Each certified surgeon is required to regularly review the surgical protocol and the technical components of the procedure.
Surgical trajectory: The incision and burr-hole location are determined using an AI-integrated neuroimaging automatic surgical trajectory planning system. The planning principles include, but are not limited to: avoiding critical functional areas such as language and motor cortices; avoiding vascular-dense regions; and selecting the individualized optimal trajectory based on the three-dimensional morphology and spatial orientation of the hematoma.
Plan review by supporting units: All preoperative imaging data and trajectory plans are automatically stored and uploaded b
Traditional Surgical ApproachesProcedure or surgery
A small craniotomy or large bone flap craniotomy is performed to microscopically evacuate the basal ganglia hematoma, followed by electrocoagulation for hemostasis. Depending on preoperative brain herniation or intraoperative brain swelling, the surgeon may decide whether to remove the bone flap.
| Study group | Role | What they receive |
|---|---|---|
| Robot-Assisted Endoscopic Minimally Invasive Surgery | Experimental | Neurosurgeons participating in the robot-assisted endoscopic procedure must be qualified doctors who have completed standardized training and certification by the coordinating center. They must be capable of performing endoscopic hematoma evacuation and managing common intraoperative complications. Each certified surgeon is required to regularly review the surgical protocol and the technical components of the procedure.
Surgical trajectory: The incision and burr-hole location are determined using an AI-integrated neuroimaging automatic surgical trajectory planning system. The planning principles include, but are not limited to: avoiding critical functional areas such as language and motor cortices; avoiding vascular-dense regions; and selecting the individualized optimal trajectory based on the three-dimensional morphology and spatial orientation of the hematoma.
Plan review by supporting units: All preoperative imaging data and trajectory plans are automatically stored and uploaded Receives: Procedure: Robot-Assisted Endoscopic Minimally Invasive Surgery |
| Traditional Surgical Approaches | Sham comparator | A small craniotomy or large bone flap craniotomy is performed to microscopically evacuate the basal ganglia hematoma, followed by electrocoagulation for hemostasis. Depending on preoperative brain herniation or intraoperative brain swelling, the surgeon may decide whether to remove the bone flap. Receives: Procedure: Traditional Surgical Approaches |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Rankin Scale (mRS) score at 6 months
The primary analysis will compare differences between the two groups based on utility-weighted mRS.
Measured: up to 6 months
Secondary outcomes (11)
Ordinal shift in mRS scores at 6 months (ordinal shift)
The difference in the distribution of scores on the modified Rankin Scale (mRS, range 0-6) between the treatment and control groups was assessed at 6 months after onset (or treatment) using a shift analysis.
Measured: up to 6 months
Favorable functional outcome at 6 months (mRS 0-1)
The proportion of patients achieving an excellent functional outcome (defined as mRS score of 0 or 1) at 6 months.
Measured: up to 6 months
Functional independence at 6 months (mRS 0-2)
The proportion of patients achieving functional independence (defined as mRS score of 0, 1, 2) at 6 months.
Measured: up to 6 months
Health-related quality of life (HRQoL) at 6 months, assessed by the EQ-5D-5L questionnaire
Assessed using the EQ-5D-5L questionnaire at 6 months post-onset/post-surgery. The instrument comprises five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) with five levels of severity, plus a Visual Analogue Scale (EQ-VAS)
Measured: up to 6 months
Total length of hospital stay
Total length of hospital stay is defined as the number of days from admission to discharge from the neurosurgical unit.
Measured: up to 6 months
Cognitive function at 6 months
Cognitive status will be evaluated at the 6-month follow-up visit using the Montreal Cognitive Assessment (MoCA).
Measured: up to 6 months
Hematoma clearance rate at 48 hours postoperatively
Hematoma volumes were quantified using semi-automated planimetric analysis (e.g., 3D Slicer software) on standard non-contrast CT scans obtained at baseline and 48 hours after surgery. This method was chosen to ensure accuracy over the ellipsoid (ABC/2) method, particularly for irregular post-operative hematoma shapes
Measured: up to 6 months
Costs during hospitalization
Direct medical costs incurred during the inpatient period were extracted from the hospital information system. Costs were categorized into four domains: (1) surgical and anesthesia fees (including disposables); (2) ward and ICU nursing fees; (3) medication costs; and (4) diagnostic imaging and laboratory fees
Measured: up to 6 months
Intraoperative blood loss
Blood loss was estimated using the standard formula: $Total Loss = (Volume_{suction} - Volume_{irrigation}) + (Weight_{wet\ gauze} - Weight_{dry\ gauze}).
Measured: up to 6 months
Incidence of rebleeding within 14 days
Rebleeding was defined as a radiographic expansion of the hematoma volume by > 33% or an absolute increase of > 5 mL on follow-up CT scans compared with the post-operative baseline CT.
Measured: up to 6 months
Incidence of related complications within 14 days, including pulmonary infection, aphasia, seizures, and deep vein thrombosis of the lower limbs
Incidence of perioperative complications within 14 days. Specific Complications: Pulmonary Infection: Defined according to CDC criteria, requiring radiographic evidence of new infiltrates combined with clinical signs (fever, purulent sputum). Aphasia: Defined as new-onset language deficits or worsening of existing aphasia (NIHSS language subscore increase ≥ 1). Seizures: Documented clinical epileptic events confirmed by neurological examination or EEG. Deep Vein Thrombosis (DVT): Confirmed by Doppler ultrasonography screening performed between postoperative days 7 and 14.
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start20 Dec 2025
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematoma BrainStudies of the same condition, open and under way.
- More trials run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolThe 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
- Model description
- The intervention group will undergo robot-assisted endoscopic hematoma evacuation, while the control group will receive traditional surgical approaches (such as small craniotomy or large-bone-flap intracranial hematoma evacuation).
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 198 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Second Affiliated Hospital, Zhejiang University, School of Medicine, Affiliated Hospital of Nantong University, The First People's Hospital of Lianyungang, Huashan Hospital, China-Japan Friendship Hospital, The First Affiliated Hospital of Zhengzhou University, Second Affiliated Hospital of Xi'an Jiaotong University, Shaoxing Central Hospital, Jinhua Central Hospital, The Second Affiliated Hospital of Kunming Medical University, First Affiliated Hospital of Guangxi Medical University, First Affiliated Hospital of Chongqing Medical University, Shanghai East Hospital, The First Affiliated Hospital of Anhui Medical University, Renmin Hospital of Wuhan University, The First Affiliated Hospital of Nanchang University, Aerospace Center Hospital, Hebei General Hospital, First Affiliated Hospital of Harbin Medical University, The Affiliated Hospital of Inner Mongolia Medical University, Jinshan Hospital Fudan University, Minhang District Central Hospital of Shanghai
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06484374
- Sponsor's protocol ID
- SQ2023AAA030147
- Acronym
- RAINBOW-LBH
- Status last verified
- Jun 2025
- First submitted
- 26 Jun 2024
- Last updated
- 17 Feb 2026
- 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 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, RAndomlzed, coNtrolled, umBrella Trial fOr Minimally Invasive Neurosurgery With Al-assisted Robotic guidanCe for Hemorrhagic Stroke: Large Basal Ganglia Hemorrhage
- ClinicalTrials.gov ID
- NCT06484374
- Acronym / sponsor ID
- RAINBOW-LBH / SQ2023AAA030147
- Conditions
- Hematoma Brain, Large Basal Ganglia Hemorrhage
- Keywords
- Large Basal Ganglia Hemorrhage, Al-assisted robotic guidance, multicenter, Randomlzed, controlled, umbrella trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 198 participants (estimated)
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolUniversity, hospital or other
- Collaborators
- Second Affiliated Hospital, Zhejiang University, School of Medicine, Affiliated Hospital of Nantong University, The First People's Hospital of Lianyungang, Huashan Hospital, China-Japan Friendship Hospital, The First Affiliated Hospital of Zhengzhou University, Second Affiliated Hospital of Xi'an Jiaotong University, Shaoxing Central Hospital, Jinhua Central Hospital, The Second Affiliated Hospital of Kunming Medical University, First Affiliated Hospital of Guangxi Medical University, First Affiliated Hospital of Chongqing Medical University, Shanghai East Hospital, The First Affiliated Hospital of Anhui Medical University, Renmin Hospital of Wuhan University, The First Affiliated Hospital of Nanchang University, Aerospace Center Hospital, Hebei General Hospital, First Affiliated Hospital of Harbin Medical University, The Affiliated Hospital of Inner Mongolia Medical University, Jinshan Hospital Fudan University, Minhang District Central Hospital of Shanghai
- Study start
- 20 Dec 2025 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 3 Jul 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.
This substudy is a prospective, multicenter, parallel-controlled, randomized controlled trial designed to evaluate whether robot-assisted endoscopic evacuation of large basal ganglia hematomas can improve patient outcomes compared with traditional surgical approaches such as small craniotomy or large-bone-flap intracranial hematoma evacuation.
Detailed description
This substudy adopts an open-label design, while outcome assessment is performed in a blinded manner. The primary outcome is the modified Rankin Scale (mRS) at 6 months. Outcomes at 30 days, 90 days, and 6 months will also be assessed. Follow-up will be conducted at baseline; 24 hours after surgery/ 30 hours after randomization; 48 hours; Day 3; Day 14 or at discharge; Day 30; Day 90; and Month 6. During follow-up, data will be collected on mortality, survival, ambulation status, living situation, modified Rankin Scale, EQ-5D-5L, Fatigue Severity Scale, AD8, Lawton-Brody Instrumental Activities of Daily Living Scale, National Institutes of Health Stroke Scale (NIHSS), Glasgow Coma Scale, laboratory tests, and neuroimaging findings.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- The intervention group will undergo robot-assisted endoscopic hematoma evacuation, while the control group will receive traditional surgical approaches (such as small craniotomy or large-bone-flap intracranial hematoma evacuation).
| Arm | Type | Receives |
|---|---|---|
| Robot-Assisted Endoscopic Minimally Invasive Surgery | Experimental | Procedure: Robot-Assisted Endoscopic Minimally Invasive SurgeryNeurosurgeons participating in the robot-assisted endoscopic procedure must be qualified doctors who have completed standardized training and certification by the coordinating center. They must be capable of performing endoscopic hematoma evacuation and managing common intraoperative complications. Each certified surgeon is required to regularly review the surgical protocol and the technical components of the procedure. Surgical trajectory: The incision and burr-hole location are determined using an AI-integrated neuroimaging automatic surgical trajectory planning system. The planning principles include, but are not limited to: avoiding critical functional areas such as language and motor cortices; avoiding vascular-dense regions; and selecting the individualized optimal trajectory based on the three-dimensional morphology and spatial orientation of the hematoma. Plan review by supporting units: All preoperative imaging data and trajectory plans are automatically stored and uploaded |
| Traditional Surgical Approaches | Sham comparator | Procedure: Traditional Surgical ApproachesA small craniotomy or large bone flap craniotomy is performed to microscopically evacuate the basal ganglia hematoma, followed by electrocoagulation for hemostasis. Depending on preoperative brain herniation or intraoperative brain swelling, the surgeon may decide whether to remove the bone flap. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥18 years at randomization;
- Diagnosed with hypertensive basal ganglia hemorrhage via imaging (CT, CTA, etc.);
- Hematoma volume ≥30 mL prior to randomization;
- Glasgow Coma Scale (GCS) score ≥ 5;
- Available for surgery within 72 hours after onset;
Key exclusion criteria (7 listed)
- Hematoma involving the thalamus (volume >5 mL or diameter >2 cm), midbrain, or ventricles (Graeb score ≥3), or other locations;
- Radiologically confirmed cerebral vascular abnormalities including ruptured aneurysms, arteriovenous malformations (AVMs), or Moyamoya disease; hemorrhagic transformation of ischemic infarcts; or recent (within 1 year) recurrence of intracerebral hemorrhage;
- Signs of impending herniation such as midline shift exceeding 1 cm or ipsilateral pupillary changes;
- Any irreversible coagulation disorder or known coagulopathy; platelet count <100,000; INR >1.4; or use of anticoagulant medication within 7 days before the current hemorrhage;
- Current or probable pregnancy;
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 |
|---|---|---|
| Robot-Assisted Endoscopic Minimally Invasive SurgeryNeurosurgeons participating in the robot-assisted endoscopic procedure must be qualified doctors who have completed standardized training and certification by the coordinating center. They must be capable of performing endoscopic hematoma evacuation and managing common intraoperative complications. Each certified surgeon is required to regularly review the surgical protocol and the technical components of the procedure. Surgical trajectory: The incision and burr-hole location are determined using an AI-integrated neuroimaging automatic surgical trajectory planning system. The planning principles include, but are not limited to: avoiding critical functional areas such as language and motor cortices; avoiding vascular-dense regions; and selecting the individualized optimal trajectory based on the three-dimensional morphology and spatial orientation of the hematoma. Plan review by supporting units: All preoperative imaging data and trajectory plans are automatically stored and uploaded b | Procedure or surgery | Robot-Assisted Endoscopic Minimally Invasive Surgery |
| Traditional Surgical ApproachesA small craniotomy or large bone flap craniotomy is performed to microscopically evacuate the basal ganglia hematoma, followed by electrocoagulation for hemostasis. Depending on preoperative brain herniation or intraoperative brain swelling, the surgeon may decide whether to remove the bone flap. | Procedure or surgery | Traditional Surgical Approaches |
Primary outcome
Modified Rankin Scale (mRS) score at 6 months
Time frame: up to 6 months
The primary analysis will compare differences between the two groups based on utility-weighted mRS.
11 secondary outcomes
Ordinal shift in mRS scores at 6 months (ordinal shift)
Time frame: up to 6 months
Favorable functional outcome at 6 months (mRS 0-1)
Time frame: up to 6 months
Functional independence at 6 months (mRS 0-2)
Time frame: up to 6 months
Health-related quality of life (HRQoL) at 6 months, assessed by the EQ-5D-5L questionnaire
Time frame: up to 6 months
Total length of hospital stay
Time frame: up to 6 months
Cognitive function at 6 months
Time frame: up to 6 months
Hematoma clearance rate at 48 hours postoperatively
Time frame: up to 6 months
Costs during hospitalization
Time frame: up to 6 months
Intraoperative blood loss
Time frame: up to 6 months
Incidence of rebleeding within 14 days
Time frame: up to 6 months
Incidence of related complications within 14 days, including pulmonary infection, aphasia, seizures, and deep vein thrombosis of the lower limbs
Time frame: up to 6 months
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 17 Feb 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robot-Assisted Endoscopic Minimally Invasive Surgery and Traditional Surgical Approaches in people with Hematoma Brain and Large Basal Ganglia Hemorrhage, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School 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 7 inclusion and 7 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 17 Feb 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. 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?
Contact Chun-Hua Hang, PhD (025-83106666, hang_neurosurgery@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Rankin Scale (mRS) score at 6 months (time frame: up to 6 months). 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 17 Feb 2026.