Early Minimally Invasive Endoscopy-Guided Surgery for Spontaneous Supratentorial Intracerebral Hemorrhage in Adults

What this Trial Is About

Intracerebral hemorrhage ICH, a type of stroke causing significant death and disability, is being studied to see if early minimally invasive endoscopy-guided surgery improves patient outcomes compared to standard medical care. This trial focuses on adults with spontaneous supratentorial ICH, aiming to begin surgery within 8 hours of symptom onset. The study is a multicenter, randomized clinical trial led by Radboud University Medical Center, investigating both functional recovery and biological changes after treatment. Participants are randomly assigned to receive either minimally invasive endoscopy-guided surgery plus standard medical management or standard medical management alone. The surgical procedure uses neuronavigation-integrated devices approved for this purpose. Surgery must start within 8 hours of symptoms, and the trial includes detailed monitoring of brain imaging and immune profiles in a subgroup. The standard care group receives blood pressure management, stroke unit admission, and supportive care. Participants will be followed for up to one year with assessments at 6 days, 90 days, 180 days, and 365 days including functional scales like the modified Rankin Scale, stroke severity scores, quality of life questionnaires, and safety monitoring for complications or death. Imaging studies at baseline, 24 hours, and day 6 assess clot and edema changes. The trial also evaluates cost-effectiveness of the surgical approach. Overall participation spans up to one year with multiple clinical and imaging evaluations.

Dutch Intracerebral Hemorrhage Surgery Trial