Early Minimally Invasive Removal of Intracerebral Hemorrhage (ENRICH): Study protocol for a multi-centered two-arm randomized adaptive trial

• Type of Material: Article
• Authors: Gustavo Pradilla Andrade, Emory University; Jonathan Ratcliff, Emory University; Alex Hall, Emory University; Edoardo Porto, Emory University; Benjamin R Saville, Berry Consultants LLC; Roger J Lewis, Berry Consultants LLC; Jason Allen, Emory University; Michael Frankel, Emory University; David Wright, Emory University; Daniel Barrow, Emory University; Gustavo Pradilla, Emory University
• Language: English
• Date: 2023-03-16
• Publisher: FRONTIERS MEDIA SA
• Publication Version: Final Published Version
• Copyright Statement: © 2023 Ratcliff, Hall, Porto, Saville, Lewis, Allen, Frankel, Wright, Barrow and Pradilla.
• License: Creative Commons Attribution 4.0 International
• Final Published Version (URL): http://dx.doi.org/10.3389/fneur.2023.1126958
• Title of Journal or Parent Work: FRONTIERS IN NEUROLOGY
• Volume: 14
• Start Page: 1126958
• End Page: 1126958
• Grant/Funding Information: This study received funding from NICO Corporation. The SLT at Emory University and representatives of the funder oversee trial design, leadership, and conduct. The SLT oversees all clinical trial activities including design, protocol development, protocol amendments, database development, and final analyses and interpretation of data. The funder will perform monitoring at all sites to ensure data quality and integrity, and the protection of the rights and safety of subjects through a contract research organization.
• Keywords: GRADING SCALE; PERIHEMATOMAL EDEMA; INITIAL CONSERVATIVE TREATMENT; minimally invasive trans-sulcal parafascicular surgery; METAANALYSIS; BLOOD-PRESSURE; NATURAL-HISTORY; EARLY SURGERY; EVACUATION; intracerebral hemorrhage (ICH); lobar ICH; Science & Technology; Life Sciences & Biomedicine; Neurosciences; SAFETY; Neurosciences & Neurology; Clinical Neurology; STICH; minimally invasive surgery (MIS); deep ICH
• Research Categories: Health Sciences, Medicine and Surgery; Biology, Biostatistics

Abstract

Background: Intracerebral hemorrhage (ICH) is a potentially devastating condition with elevated early mortality rates, poor functional outcomes, and high costs of care. Standard of care involves intensive supportive therapy to prevent secondary injury. To date, there is no randomized control study demonstrating benefit of early evacuation of supratentorial ICH. Methods: The Early Minimally Invasive Removal of Intracerebral Hemorrhage (ENRICH) Trial was designed to evaluate the minimally invasive trans-sulcal parafascicular surgery (MIPS) approach, a technique for safe access to deep brain structures and ICH removal using the BrainPath® and Myriad® devices (NICO Corporation, Indianapolis, IN). ENRICH is a multi-centered, two-arm, randomized, adaptive comparative-effectiveness study, where patients are block randomized by ICH location and Glasgow Coma Score (GCS) to early ICH evacuation using MIPS plus standard guideline-based management vs. standard management alone to determine if MIPS results in improved outcomes defined by the utility-weighted modified Rankin score (UWmRS) at 180 days as the primary endpoint. Secondary endpoints include clinical and economic outcomes of MIPS using cost per quality-adjusted life years (QALYs). The inclusion and exclusion criteria aim to capture a broad group of patients with high risk of significant morbidity and mortality to determine optimal treatment strategy. Discussion: ENRICH will result in improved understanding of the benefit of MIPS for both lobar and deep ICH affecting the basal ganglia. The ongoing study will lead to Level-I evidence to guide clinicians treatment options in the management of acute treatment of ICH. Trial registration: This study is registered with clinicaltrials.gov (Identifier: NCT02880878).