AI-driven navigated hematoma aspiration vs. conservative treatment for spontaneous intracerebral hemorrhage: study protocol for a randomized controlled trial.
Xinghua Xu, Jiashu Zhang, Qingzhen Yuan...
https://pubmed.ncbi.nlm.nih.gov/42021277Actively Recruiting
Phase Not Applicable
Age: 18Years - 80Years
All Genders
ID07077343
Comparison of AI-assisted Navigated Hematoma Aspiration With Conservative Treatment for Spontaneous Intracerebral Hemorrhage: A Multicenter Randomized Controlled Trial
Led by Xiaolei Chen · Updated on 2026-04-27
680
Participants Needed
1
Research Sites
25 weeks
Total Duration
On this page
Sponsors
X
Xiaolei Chen
Lead Sponsor
J
Jingzhou Central Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating treatment options for patients with spontaneous supratentorial intracerebral hemorrhage (ICH) who have a moderate hematoma volume between 20 and 50 mL. The study aims to compare the clinical effectiveness and safety of two minimally invasive approaches: AI-assisted, navigation-guided hematoma aspiration versus targeted pharmacological therapy. This multicenter randomized controlled trial seeks to provide evidence to guide treatment decisions and improve individualized care for patients with this serious stroke condition. Participants will be randomly assigned to one of two groups. The first group undergoes AI-assisted hematoma aspiration, where AI algorithms help guide precise catheter placement through a minimally invasive burr-hole procedure, performed under local or general anesthesia. The second group receives conservative pharmacological treatment aimed at promoting hematoma resolution and neuroprotection. Both groups will receive standardized supportive neurocritical care, including blood pressure and intracranial pressure management. During the study, patients will be monitored with brain imaging, neurological assessments, and functional evaluations using tools such as the modified Rankin Scale (mRS) at 6 months, Glasgow Coma Scale (GCS), and NIH Stroke Scale (NIHSS). Researchers will track hematoma resolution, complications, mortality, quality of life, and healthcare resource use. Follow-up lasts 6 months post-treatment, with independent evaluators assessing outcomes to ensure objective analysis.
CONDITIONS
Brief Title
AI-Guided Hematoma Aspiration vs. Conservative Treatment for Spontaneous ICH
Who Can Participate
Age: 18Years - 80Years
All Genders
Eligibility Criteria
You may qualify if you...
- Confirmed supratentorial hypertensive intracerebral hemorrhage on brain CT scan
- Hematoma volume between 20 and 50 mL
- Glasgow Coma Scale score of 8 or higher
- Admission within 24 hours of symptom onset
- Age between 18 and 80 years
You will not qualify if you...
- Intracerebral hemorrhage caused by tumor, coagulopathy, aneurysm, or arteriovenous malformation
- Concurrent head injury or history of head injury
- Multiple intracerebral hemorrhages
- Known advanced dementia or disability before
- Severe concomitant diseases affecting life expectancy
- Severe intraventricular hemorrhage
- Pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 24 hours from symptom onset to randomization and treatment delivery
Participants receive either AI-assisted navigated hematoma aspiration via a minimally invasive procedure or conservative pharmacological therapy focused on medical stabilization and neuroprotection.
1 procedure visit and postoperative imaging within 24 hours for the aspiration group; 1 baseline medical management visit for the conservative treatment group
Follow-up
Duration - 6 months
Participants are monitored for neurological status, functional outcomes, complications, and quality of life after treatment.
Visits at hospital discharge, day 7, day 30, day 90, and 6 months post-treatment
Trial Site Locations
Total: 1 location
1
Chinese PLA General Hospital
Beijing, Beijing Municipality, China, 100853
Actively Recruiting
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Research Team
X
Xinghua Xu, MD
Q
Qun Wang, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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