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New treatment option for Basal Ganglia Hemorrhage
Official title A Trial for Minimally Invasive Neurosurgery With AI-assisted Robotic Guidance for Moderate Basal Ganglia Hemorrhage (RAINBOW-MBH)
ClinicalTrials.gov ID: NCT06465719
What this study is testing
What is Patients will be managed with guideline-based medications?
Patients will be managed with guideline-based medications is an investigational medicine, being studied as a potential treatment for basal ganglia hemorrhage.
Also referred to as Controlled Group.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- A nationwide, prospective, multicenter randomized controlled clinical trial to evaluate the therapeutic effects of the fiber tract-based artificial intelligence (AI) Robot Guiding System on the perioperative and long-term recovery of patients with moderate-volume basal ganglion hemorrhage.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥18 years at randomization
- Hypertensive basal ganglia hemorrhage confirmed by CT/CTA
- Hematoma volume 15-30 mL (excluding 30 mL)
- Functional impairment (aphasia, hemiparesis with strength ≤3, or NIHSS ≥15)
- CT shows stable hematoma (≥6h interval, change \<5 mL)
You likely can't join if
- Hematoma involving the thalamus, midbrain, or other areas
- Radiologically diagnosed cerebrovascular abnormalities, as well as ischemic infarction converting to intracerebral hemorrhage, or recent (within 1...
- Signs of impending brain herniation, such as midline shift \>1 cm or changes in the ipsilateral pupil;
- Any irreversible coagulopathy disorders or known coagulation system disease; platelet count \ 1.4; use of anticoagulants within 7 days prior to this...
- Pregnant or possibly pregnant
- Patients with severe concomitant diseases that may interfere with outcome assessment
See the full eligibility criteria
- Age ≥18 years at randomization
- Hypertensive basal ganglia hemorrhage confirmed by CT/CTA
- Hematoma volume 15-30 mL (excluding 30 mL)
- Functional impairment (aphasia, hemiparesis with strength ≤3, or NIHSS ≥15)
- CT shows stable hematoma (≥6h interval, change \<5 mL)
- GCS ≥9
- Surgery feasible within 72h after onset
- Pre-ICH mRS ≤1
- Informed consent obtained according to laws and ethics
- Hematoma involving the thalamus, midbrain, or other areas
- Radiologically diagnosed cerebrovascular abnormalities, as well as ischemic infarction converting to intracerebral hemorrhage, or recent (within 1 year) recurrence of intracerebral hemorrhage
- Signs of impending brain herniation, such as midline shift \>1 cm or changes in the ipsilateral pupil;
- Any irreversible coagulopathy disorders or known coagulation system disease; platelet count \ 1.4; use of anticoagulants within 7 days prior to this hemorrhage;
- Pregnant or possibly pregnant
- Patients with severe concomitant diseases that may interfere with outcome assessment
- Poor compliance or follow-up difficulties
The study team makes the final eligibility decision.
Where it's taking place
- Hangzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hangzhou, Zhejiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.