More than 100 patients are now enrolled in the ENRICH randomised controlled trial. The trial is designed to compare the outcomes between early surgical intervention of clot removal using the minimally disruptive BrainPath Approach (NICO Corporation) and the “watch and see” medical management standard of care.
ENRICH (Early MiNimally-invasive Removal of ICH) opened patient enrolment in January 2017 for the 300-patient trial that uniquely includes multi-disciplinary teams of stroke neurology, neurosurgery and neuro-critical care physicians from each of the 30 trial sites that include major medical and academic centres and large community hospitals. Nearly 100 site surveys were received from interested sites to participate in the trial.
ENRICH is a multi-centre trial sponsored by NICO and led by the Emory Stroke Centre of Emory University hospitals and the Marcus Stroke & Neuroscience Centre of Grady Memorial Hospital, both in Atlanta, USA. Ideal trial subjects are spontaneous supratentorial intracerebral haemorrhage (ICH) patients with a potential chance of benefiting from surgical treatment based on well-defined criteria for study enrolment.
The current standard of care for ICH calls for medical management of the patient that often allows blood to remain in the brain, causing mass effect and toxicity that triggers a grim clinical outcome for the patient and early mortality rates of 32–50%. The ENRICH goal is to compare the efficacy and safety of standard medical management of ICH to early surgical evacuation (less than 24 hours) using the BrainPath Approach, a parafascicular (parallel to the brain’s fibre tracts) and trans-sulcal (natural openings and folds of the brain) surgical approach which aims to achieve maximum clot removal, durable haemostasis, and functional improvement of the patient. The BrainPath Approach uses the NICO BrainPath for minimally-disruptive access and automated NICO Myriad for clot evacuation.