AI-guided hematoma aspiration versus conservative drug therapy for spontaneous intracerebral hemorrhage
Official title: Comparison of AI-assisted Navigated Hematoma Aspiration With Conservative Treatment for Spontaneous Intracerebral Hemorrhage: A Multicenter Randomized Controlled Trial
Run by Chinese PLA General Hospital · NCT07077343 · Data updated 2026-11-12
This trial will test whether AI-assisted, navigation-guided hematoma aspiration or targeted pharmacological therapy leads to better recovery for people with moderate-volume spontaneous supratentorial intracerebral hemorrhage.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 680 (estimated) |
| Sponsor | Chinese PLA General Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Status | Recruiting |
| Started | July 1, 2025 |
| Main results expected | December 31, 2030 |
| Study ends | June 30, 2031 |
| Registry record updated | April 27, 2026 |
| Trial ID | NCT07077343 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with spontaneous supratentorial ICH of 20–50 mL volume, admitted within 24 hours of symptom onset with GCS ≥8 and no structural cause of hemorrhage are the intended candidates.
✕Probably not a fit
Patients with infratentorial hemorrhage, very small or very large hematomas, coagulopathy, aneurysm/AVM/tumor-related bleeding, severe intraventricular hemorrhage, pre-existing major disability, or pregnancy are unlikely to benefit from inclusion.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective, multicenter, randomized trial comparing two minimally invasive approaches for spontaneous supratentorial intracerebral hemorrhage with hematoma volumes of 20–50 mL. One arm uses AI-assisted navigation to guide percutaneous hematoma aspiration, and the other uses targeted pharmacological (conservative) therapy. Key outcomes include functional recovery (modified Rankin Scale), hematoma resolution on imaging, and safety/adverse events. Eligible patients are adults admitted within 24 hours with GCS ≥8 and no structural causes or severe comorbidities.
Why it matters
Potential benefit: If successful, AI-guided aspiration could improve functional outcomes and speed hematoma clearance while reducing brain injury compared with conservative drug therapy.
How similar studies have gone: Prior minimally invasive hematoma evacuation trials have shown mixed functional results (for example MISTIE), and AI-guided navigation is a newer approach that has not yet been proven in large randomized trials.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Confirmed supratentorial hypertensive intracerebral hemorrhage on brain CT scan * Hematoma volume 20-50mL * Patients with with GCS score ≥8 * Admitted within 24h of ictus Exclusion Criteria: * Intracerebral hemorrhage caused by tumor, coagulopathy, aneurysm, or arteriovenous malformation * Concurrent head injury or history of head injury * Multiple intracerebral hemorrhage * Known advanced demential or disability before * Severe concomitant diseases that affect life expectancy * With severe intraventricular hemorrhage * Pregnant women
Where it's running
-
Chinese PLA General Hospital
Beijing, Beijing Municipality, China Recruiting
Study contacts
- Principal investigator: Xiaolei Chen, MD — Chinese PLA General Hospital
- Study coordinator: Xinghua Xu, MD
- Email: dr_xxh@126.com
- Phone: 86-18811212273
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.