AI-driven navigated hematoma aspiration vs. conservative treatment for spontaneous intracerebral hemorrhage: study protocol for a randomized controlled trial

BACKGROUND: Spontaneous intracerebral hemorrhage (ICH) remains one of the most devastating types of stroke, with high mortality and long-term disability. Minimally invasive hematoma evacuation techniques have been developed to improve outcomes by reducing hematoma volume while minimizing surgical trauma compared with conventional craniotomy or conservative treatment. Artificial intelligence (AI) and neuronavigation enable optimized trajectory planning, real-time intraoperative guidance, and individualized treatment strategies, potentially leading to improved clinical outcomes compared with conservative treatment. This study aims to compare the efficacy and safety of AI-driven navigated hematoma aspiration with conservative therapy. METHODS: This multicenter, prospective, randomized controlled, open-label trial with blinded outcome assessment will enroll approximately 680 patients with spontaneous supratentorial ICH (20-50 mL) within 24 h of onset and a Glasgow Coma Scale (GCS) score ≥ 8. Eligible patients aged 18-80 years will be randomly assigned in a 1:1 ratio to receive either AI-assisted, navigation-guided hematoma aspiration plus best medical therapy or best medical therapy alone. Randomization will be centralized and stratified by center. The primary outcome is functional status at 6 months, assessed by the modified Rankin Scale, with mRS 0-2 defined as a favorable outcome. Secondary outcomes include mortality, hematoma volume reduction, neurological function, complications, quality of life, length of hospital stay, and cost-effectiveness. DISCUSSION: This trial is designed to provide robust evidence on the efficacy and safety of AI-guided hematoma aspiration for ICH. If successful, it has the potential to support a precise and minimally invasive treatment strategy and improve clinical outcomes. TRIAL REGISTRATION: Clinical Trials NCT07077343. Registered on July 21, 2025.