Ratcliff Jonathan J, Hall Alex J, Porto Edoardo, Saville Benjamin R, Lewis Roger J, Allen Jason W, Frankel Michael, Wright David W, Barrow Daniel L, Pradilla Gustavo
Department of Emergency Medicine, Emory University School of Medicine, Atlanta, GA, United States.
Department of Neurology, Emory University School of Medicine, Grady Hospital, Atlanta, GA, United States.
Front Neurol. 2023 Mar 16;14:1126958. doi: 10.3389/fneur.2023.1126958. eCollection 2023.
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.
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.
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.
This study is registered with clinicaltrials.gov (Identifier: NCT02880878).
脑出血（ICH）是一种潜在的毁灭性疾病，早期死亡率高，功能预后差，护理成本高。护理标准包括强化支持治疗以预防继发性损伤。迄今为止，尚无随机对照研究证明早期清除幕上脑出血的益处。
早期微创清除脑出血（ENRICH）试验旨在评估微创经脑沟旁束手术（MIPS）方法，这是一种使用BrainPath和Myriad设备（NICO公司，印第安纳波利斯，印第安纳州）安全进入深部脑结构并清除脑出血的技术。ENRICH是一项多中心、双臂、随机、适应性比较疗效研究，患者按脑出血位置和格拉斯哥昏迷评分（GCS）进行区组随机分组，分别接受MIPS联合基于标准指南管理的早期脑出血清除术与单纯标准管理，以确定MIPS是否能改善以180天效用加权改良Rankin评分（UWmRS）为主要终点的预后。次要终点包括使用每质量调整生命年（QALY）成本的MIPS临床和经济结果。纳入和排除标准旨在纳入一组具有高发病率和死亡率风险的广泛患者，以确定最佳治疗策略。
ENRICH将有助于更好地理解MIPS对影响基底节的脑叶和深部脑出血的益处。正在进行的研究将产生一级证据，以指导临床医生在脑出血急性治疗管理中的治疗选择。
本研究已在clinicaltrials.gov注册（标识符：NCT02880878）。
