A Multicenter, RAndomIzed, coNtrolled, umBrella Trial fOr Minimally Invasive Neurosurgery With AI-assisted Robotic guidanCe for Hemorrhagic Stroke (RAINBOW-BSH)

Yanbing Yu

Status: Begins enrollment in 1 month

Conditions: Brain Stem Hemorrhage; Robotic Surgical Procedures

Treatments: Procedure: Robot-assisted minimally invasive puncture and aspiration surgery; Drug: Conventional medical conservative group

Study type: Interventional

Funder types: Other

Identifiers

NCT06459427

01084205031

Details and patient eligibility

About

The purpose of this clinical trial is to observe the improvements in clinical symptoms and imaging outcomes for brainstem hemorrhage using robot-assisted stereotactic puncture, evaluate the clinical efficacy and safety of this treatment, and explore the development of a high-precision, intelligent, and individualized microsurgical diagnosis and treatment process for brainstem hemorrhage. The main questions it aims to address are:

• Establish a multi-center clinical database for brainstem hemorrhage.
• Clinically observe and evaluate the intervention effects of robot-assisted stereotactic puncture on brainstem hemorrhage, compare it with the traditional conservative treatment control group, and investigate its efficacy and impact on patient survival, motor evoked potentials, and the degree of neurological deficits.
• Optimize the Artificial Intelligence (AI) algorithm-based robotic surgical assistance system, and explore the prediction of preoperative brainstem hematoma stability and hematoma path planning.

Participants in the experimental group will:

• Undergo robot-assisted stereotactic minimally invasive surgery for brainstem hematoma puncture
• Receive conservative non-surgical treatment.

If there is a control group: the researchers will compare the conservative non-surgical treatment group to evaluate the effectiveness of robot-assisted stereotactic minimally invasive surgery for brainstem hematoma puncture.

Enrollment: 142 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Participants must meet all of the following inclusion criteria:

1. Age ≥18 years at randomization；
2. Diagnosed with brainstem hemorrhage via imaging (CT, CTA, etc.)；
3. Hematoma volume ≥3 mL；
4. Glasgow Coma Scale (GCS) score of 3-12；
5. Available for surgery within 48 hours after onset；
6. Modified Rankin Scale (mRS) score ≤ 1 prior to this hemorrhage；
7. Informed consent obtained in accordance with national laws, regulations, and applicable ethics committee requirements.

Patients will be excluded if they meet any of the following criteria:

1. Hematoma involving other regions such as the supratentorial compartment, basal ganglia, thalamus, midbrain, or ventricles.
2. 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；
3. Any irreversible coagulation disorder or known coagulopathy; platelet count <100,000/µL; INR >1.4; or use of anticoagulant medication within 7 days before the current hemorrhage；
4. Current or probable pregnancy；
5. Patients with concurrent severe illness likely to influence outcome assessment；
6. Difficulty in follow-up or poor compliance due to any cause.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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142 participants in 2 patient groups

Robot-assisted minimally invasive puncture and aspiration surgery

Experimental group

Description:

The intervention group will receive robot-assisted stereotactic puncture for brainstem hemorrhage

Treatment:

Drug: Conventional medical conservative group

Procedure: Robot-assisted minimally invasive puncture and aspiration surgery

Conventional medical conservative group

Active Comparator group

Description:

The control group will undergo conventional medical conservative management.

Treatment:

Drug: Conventional medical conservative group