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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorXiaolei Chen

About this trial

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 criteria

Qualifiers

Confirmed supratentorial hypertensive intracerebral hemorrhage on brain CT scan

Hematoma volume 20-50mL

Patients with with GCS score ≥8

Admitted within 24h of ictus

Disqualifiers

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

Trial design

Treatments tested in this trial

  • AI-Assisted Navigated Hematoma Aspiration
  • Conservative Treatment

Treatment groups

680 Participants
are divided into 2 treatment groups

Locations

1
Chinese PLA General Hospital100853, BeijingBeijing Municipality, China

Sponsors and collaborators

Xiaolei Chen

Lead sponsor

Chinese PLA General Hospital

Sponsor institution

Jingzhou Central Hospital

Collaborator

Wuhan No.1 Hospital

Collaborator

People's Hospital of Guangxi Zhuang Autonomous Region

Collaborator

Siping Central People's Hospital

Collaborator

Yichang Central People's Hospital

Collaborator

Peking University First Hospital

Collaborator

First Affiliated Hospital of Xinjiang Medical University

Collaborator

First Affiliated Hospital, Sun Yat-Sen University

Collaborator