Comparison of AI-assisted Navigated Hematoma Aspiration With Conservative Treatment for Spontaneous Intracerebral Hemorrhage: A Multicenter Randomized Controlled Trial

Background and Rationale Spontaneous intracerebral hemorrhage (ICH) is a devastating form of stroke with high morbidity and mortality, especially in low- and middle-income populations. Traditional open craniotomy for hematoma evacuation remains controversial due to its invasiveness and the associated risk of secondary brain injury. In recent years, minimally invasive approaches have gained traction, particularly in patients with moderate hematoma volume. Among them, AI-assisted navigation-guided hematoma aspiration offers the promise of precise, real-time trajectory planning and minimized parenchymal disruption. In parallel, pharmacological approaches that promote hematoma resolution and neuroprotection-termed "targeted pharmacological therapy"-are emerging as non-surgical alternatives. However, no large-scale, prospective randomized controlled trials have directly compared these two strategies in patients with moderate-volume ICH (defined as 20-50 mL), a group that often poses management dilemmas in clinical practice.

Study Objective The primary aim of this study is to compare the efficacy and safety of AI-assisted navigated hematoma aspiration versusconservative therapy in patients with spontaneous supratentorial ICH of moderate volume (20-50 mL). We hypothesize that AI-assisted aspiration will yield superior functional outcomes compared to pharmacological treatment, without increasing the risk of adverse events.

Study Design This is a prospective, multicenter, randomized controlled trial involving 680 patients recruited from multiple high-volume stroke or neurosurgical centers. After obtaining informed consent, eligible participants will be randomly assigned in a 1:1 ratio to receive either AI-guided navigated hematoma aspiration or conservative therapy. Due to the nature of the interventions, this is an open-label trial; however, outcome assessment will be performed by independent evaluators blinded to the treatment allocation.

Randomization will be centralized and stratified by participating center using a computer-generated allocation sequence. All participating centers will receive standardized training to ensure protocol adherence, including surgical techniques, drug regimens, and outcome assessment procedures. The anticipated recruitment period is 24 months, with each patient followed up for a total of 6 months post-treatment.

Eligibility Criteria Participants aged between 18 and 80 years who present with spontaneous supratentorial ICH confirmed by non-contrast CT scan will be considered for inclusion. Eligible patients must have a hematoma volume between 20 and 50 mL as meassured with the 3D Slicer software, and a Glasgow Coma Scale (GCS) score of at least 8 upon admission. Patients must be randomized within 24 hours of symptom onset. Exclusion criteria include infratentorial hemorrhage, secondary causes of ICH (e.g., trauma, vascular malformations, tumors), severe comorbidities, coagulopathy that cannot be reversed, and pregnancy.