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

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.

Conditions

• Intracerebral Hemorrhage

Interventions

PROCEDURE

AI-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.

PROCEDURE

Conservative 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.

Sponsors & Collaborators

• Jingzhou Central Hospital

  collaborator OTHER

• Wuhan No.1 Hospital

  collaborator OTHER

• People's Hospital of Guangxi Zhuang Autonomous Region

  collaborator OTHER

• Siping Central People's Hospital

  collaborator OTHER

• Yichang Central People's Hospital

  collaborator OTHER

• Peking University First Hospital

  collaborator OTHER

• First Affiliated Hospital of Xinjiang Medical University

  collaborator OTHER

• First Affiliated Hospital, Sun Yat-Sen University

  collaborator OTHER

• Xiaolei Chen

  lead OTHER

Principal Investigators

• Xiaolei Chen, MD · Chinese PLA General Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-07-01

Primary Completion

2030-12-31

Completion

2031-06-30

Countries

• China

Study Locations