The purpose of the ENRICH trial is to provide clinical evidence of functional improvement, safety and economic benefit, measured by various endpoints, when comparing early surgical evacuation to the standard of care medical management for ICH.
The ENRICH trial began in December 2016 and will include at least 15 centers. The estimated primary completion date is December 2019, with final data collection completed for primary outcome measurement. Full study completion is expected in July 2020. Patient enrollment of 300 is estimated to take one year, with six months for patient follow up. Ideal trial candidates are spontaneous supratentorial ICH patients with a good clinical chance of benefiting from the surgical treatment based on well-defined criteria for study enrollment.
The trial will build on current peer-reviewed clinical data on the BrainPath Approach including a preliminary series of 39 patients treated for supratentorial spontaneous ICH. A 2016 Neurosurgery publication retrospectively reviewed patients from 11 centers and reported on the safety and feasibility of hematoma evacuation using a trans-sulcal surgical approach with BrainPath (1). Results showed greater than or equal to 90%, 75%, and 50% degree of hematoma evacuation in 72%, 23%, and 5% of patients, respectively, as well as no new surgical deficits or mortalities. Additionally, “statistically significant” improvement in patients’ neurological state was associated with early intervention. The publication was cited as a breakthrough in the treatment of hemorrhagic stroke by the National Stroke Association.
These results were replicated in an independent single-center study conducted by the Cleveland Clinic Foundation in 18 patients and published in Operative Neurosurgery in 2016 (2). The authors at Cleveland Clinic reported mean clot volume reduction of 95.7% and a median GCS improvement from 10 to 14. In addition, the bleeding source was identified in 65% of patients and coagulated with no rebleeds resulting during follow-up.
The trial will allow centers to produce prospective data documenting the best course of action for patients who are treated for this very deadly form of stroke.
1. Labib MA, Shah M, Kassam AB, Young R, Zucker L, Maioriello A, et al. The safety and feasibility of image-guided BrainPath-mediated transsulcul hematoma evacuation: a multicenter study. Neurosurgery. 2016: Published online AOP, June 17, 2016.
2. Bauer AM, Rasmussen PA, Bain MD. Initial single-center technical experience with the BrainPath system for acute intracerebral hemorrhage evacuation. Operative Neurosurgery. 2016; 0:1-7.