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
Locations
1Sponsors 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