The Affiliated Drum Tower Hospital of Nanjing University Medical School
Nanjing, China
Location status: Recruiting
Recruiting
NCT Number: NCT06484374
A Multicenter, RAndomlzed, coNtrolled, umBrella Trial fOr Minimally Invasive Neurosurgery With Al-assisted Robotic guidanCe for Hemorrhagic Stroke: Large Basal Ganglia Hemorrhage
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Treatment and study plan
Robot-Assisted Endoscopic Minimally Invasive Surgery
ProcedureNeurosurgeons 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 Approaches
ProcedureA 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.
Primary outcomes
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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.
Secondary outcomes
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Ordinal shift in mRS scores at 6 months (ordinal shift)
Time frame: up to 6 months
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.
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Favorable functional outcome at 6 months (mRS 0-1)
Time frame: up to 6 months
The proportion of patients achieving an excellent functional outcome (defined as mRS score of 0 or 1) at 6 months.
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Functional independence at 6 months (mRS 0-2)
Time frame: up to 6 months
The proportion of patients achieving functional independence (defined as mRS score of 0, 1, 2) at 6 months.
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Health-related quality of life (HRQoL) at 6 months, assessed by the EQ-5D-5L questionnaire
Time frame: up to 6 months
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)
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Total length of hospital stay
Time frame: up to 6 months
Total length of hospital stay is defined as the number of days from admission to discharge from the neurosurgical unit.
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Cognitive function at 6 months
Time frame: up to 6 months
Cognitive status will be evaluated at the 6-month follow-up visit using the Montreal Cognitive Assessment (MoCA).
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Hematoma clearance rate at 48 hours postoperatively
Time frame: up to 6 months
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
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Costs during hospitalization
Time frame: up to 6 months
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
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Intraoperative blood loss
Time frame: up to 6 months
Blood loss was estimated using the standard formula: $Total Loss = (Volume_{suction} - Volume_{irrigation}) + (Weight_{wet\\ gauze} - Weight_{dry\\ gauze}).
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Incidence of rebleeding within 14 days
Time frame: up to 6 months
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.
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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
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.
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Other
Collaborators
- Aerospace Center Hospital
- Affiliated Hospital of Nantong University
- China-Japan Friendship Hospital
- First Affiliated Hospital of Chongqing Medical University
- First Affiliated Hospital of Guangxi Medical University
- First Affiliated Hospital of Harbin Medical University
- Hebei General Hospital
- Huashan Hospital
- Jinhua Central Hospital
- Jinshan Hospital Fudan University
- Minhang District Central Hospital of Shanghai
- Renmin Hospital of Wuhan University
- Second Affiliated Hospital of Xi'an Jiaotong University
- Second Affiliated Hospital, School of Medicine, Zhejiang University
- Shanghai East Hospital
- Shaoxing Central Hospital
- The Affiliated Hospital of Inner Mongolia Medical University
- The First Affiliated Hospital of Anhui Medical University
- The First Affiliated Hospital of Nanchang University
- The First Affiliated Hospital of Zhengzhou University
- The First People's Hospital of Lianyungang
- The Second Affiliated Hospital of Kunming Medical University
Registry information
Acronym: RAINBOW-LBH
Important dates
- Study start
- 2025
- Primary completion
- 2027
- Study completion
- 2027
- First posted
- Jul 3, 2024
- Registry last updated
- Feb 17, 2026
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.