Early Minimally Invasive Image-Guided Endoscopic Removal of Brain Hemorrhage Compared to Standard Medical Care in Adults with Spontaneous Supratentorial Intracerebral Hemorrhage

What this Trial Is About

This research aims to evaluate the effectiveness of early minimally invasive image-guided hematoma evacuation combined with best medical treatment BMT compared to BMT alone in patients with spontaneous supratentorial intracerebral hemorrhage SSICH. SSICH is a serious form of stroke with poor outcomes and limited treatment improvements from current standard care or traditional surgery. This open-labeled, randomized controlled trial seeks to determine if early endoscopic surgery within 24 hours of bleeding onset can improve functional outcomes at 6 months. Participants are randomly assigned to one of two groups. The intervention group receives BMT plus early minimally invasive endoscopic hematoma evacuation performed within 6 to 24 hours after symptom onset, using advanced imaging and neuro-navigation techniques to guide the surgical procedure. The control group receives best medical treatment alone, which includes strict blood pressure control, seizure prevention, intensive care monitoring, and other guideline-based supportive care. The study involves six visits, with four during hospital stay and two follow-ups as part of routine care. During each visit, assessments include the Glasgow Coma Scale GCS, modified Rankin Scale mRS, and National Institute of Health Stroke Scale NIHSS. Three visits involve CT scans and blood sampling, while other visits assess patient satisfaction, cognition, and quality of life. The primary outcome is functional status measured by mRS at 6 months. Secondary outcomes include mortality rates, cognitive changes, neurological deficits, quality of life, and time spent in intensive care. The trial runs until December 2029 and was designed with patient and public input.

Early Minimally Invasive Image Guided Endoscopic Evacuation of Intracerebral Haemorrhage (EMINENT-ICH)