HEMORRHAGE EVACUATION EMPLOYING MR ENDOSCOPIC SURGERY TRIAL

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DESCRIPTION (provided by the applicant): Intracerebral hemorrhage is a devastating and disabling disease, with 30-day mortality rates estimated to be between 35-52%, and only 20% of survivors independent at 6 months. Surgical therapies, to date, have not been demonstrated to be effective for ICH in randomized, controlled trials, but studies have not focused on early and novel surgical procedures. Magnetic resonance-guided endoscopic surgical evacuation is a promising technique for the treatment of primary ICH, providing minimally invasive hematoma evacuation. Part A of this project proposes a single-center, randomized, controlled, blinded outcome evaluation, phase II clinical trial of MR guided endoscopic surgical evacuation vs. conventional medical management for treatment of primary ICH within 24 hrs of symptom onset, in 60 patients over 5 years. The central aim of this proposal is to demonstrate that early magnetic resonance (MR)-guided endoscopic surgical evacuation is a feasible, and potentially efficacious, treatment for patients with acute ICH. A signal of potential efficacy will warrant launch of a pivotal trial, and data gathered in this pilot will aid in selection of the endpoint analysis and additional aspects of a phase 3 trial. In this pilot trial, the primary study endpoint will be the modified Rankin Scale of gIobal disability at 90 days, analyzed dichotomously (proportion of patients alive and independent) and quantitatively. Multi-modal MRI, including diffusion-perfusion imaging, will be employed to monitor the evolving pathophysiologic changes occurring with ICH in both surgically treated and medically managed patients to better elucidate the processes involved in perihematomal injury and their response to therapy. Part B proposes a genetic analysis substudy, in which human brain tissue, obtained from endoscopic clot removal and peri-hematomal biopsy, will be analyzed to identify the molecular mechanisms of peri-hematomal damage. Gene expression patterns will be measured using qualitative, real-time RT-PCR on a hypothesized set of neurotoxic genes, and using cDNA arrays to screen for a larger set of genes important in the evolution of intracranial hemorrhage.