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

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.

NCT Number	NCT07077343
Lead Sponsor	Xiaolei Chen Collaborators: Jingzhou Central Hospital, Wuhan No.1 Hospital, People's Hospital of Guangxi Zhuang Autonomous Region, Siping Central People's Hospital, Yichang Central People's Hospital, Peking University First Hospital, First Affiliated Hospital of Xinjiang Medical University, First Affiliated Hospital, Sun Yat-Sen University
Conditions	Intracerebral Hemorrhage
Enrollment	680 participants
Start Date	2025-07-01
Primary Completion	2030-12-31 (estimated)
Study Completion	2031-06-30 (estimated)
Updated on ClinicalTrials.gov	2026-04-27