RecruitingNot ApplicableNCT07077343

AI-Guided Hematoma Aspiration vs. Conservative Treatment for Spontaneous ICH

Comparison of AI-assisted Navigated Hematoma Aspiration With Conservative Treatment for Spontaneous Intracerebral Hemorrhage: A Multicenter Randomized Controlled Trial

Sponsor

Xiaolei Chen

Enrollment

680 participants

Start Date

Jul 1, 2025

Study Type

INTERVENTIONAL

Conditions

Intracerebral Hemorrhage

Summary

The effectiveness of traditional craniotomy in the treatment of intracerebral hemorrhage remains controversial. Minimally invasive surgery, specially, image-guided hematoma aspiration, proves to be effective and may have some advantages compared with craniotomy. This multicenter randomized controlled trial aims to evaluate and compare the clinical efficacy of two minimally invasive treatment strategies for patients with spontaneous supratentorial intracerebral hemorrhage (ICH) with moderate hematoma volume (20-50 mL): (1) AI-assisted, navigation-guided hematoma aspiration, and (2) targeted pharmacological therapy. This study is designed to address the current lack of prospective comparative evidence between advanced image-guided surgical intervention and medical management in this specific patient population. By focusing on functional recovery, hematoma resolution, and safety outcomes, this trial seeks to provide high-quality evidence to guide treatment decision-making and optimize individualized care for patients with spontaneous ICH.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria4

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 Criteria7

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

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Interventions

PROCEDUREAI-Assisted Navigated Hematoma Aspiration

By leveraging AI algorithms for real-time hematoma segmentation, volume calculation, and trajectory optimization, this approach enhances the accuracy of minimally invasive catheter placement and facilitates efficient clot removal under image-guided navigation.

PROCEDUREConservative Treatment

Compared to surgical hematoma aspiration, conservative treatment relies on medical stabilization and the body's natural clearance mechanisms, and remains the standard of care in many cases of moderate or deep-seated ICH without signs of clinical deterioration.