Extracorporeal CPR for Refractory Out-of-Hospital Cardiac Arrest (EROCA) Trial Planning Grant

难治性院外心脏骤停 (EROCA) 体外心肺复苏 (EROCA) 试验计划补助金

• 批准号: 9182635
• 负责人: Robert H. Bartlett
• 金额: $ 34.88万
• 依托单位: UNIVERSITY OF MICHIGAN AT ANN ARBOR
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-08-18 至 2018-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9182635
• 关键词: 911 call; Accident and Emergency department; Address; Adult; Beds; Blood Vessels; Cannulations; Cardiopulmonary Resuscitation; Caring; Case Series; Childhood; Clinical Trials; County; Critical Care; Data; Data Sources; Emergency Situation; Emergency medical service; Exposure to; Extracorporeal Circulation; Futility; Goals; Grant; Health system; Heart; Heart Arrest; Hospitals; Informed Consent; Intervention; Intervention Studies; Lung; Measures; Medical; Medical emergency; Methods; Michigan; Multicenter Studies; National Heart, Lung, and Blood Institute; Nervous System Physiology; Outcome; Paramedical Personnel; Patients; Performance; Phase; Phase III Clinical Trials; Pilot Projects; Protocols documentation; Provider; Publishing; Qualifying; Randomized Clinical Trials; Refractory; Reporting; Research; Resources; Resuscitation; Survival Rate; System; Testing; Therapeutic; Training; Training Programs; United States; Universities; University Hospitals; Work; authority; base; design; emergency service responder; evidence base; experience; meetings; member; multidisciplinary; primary outcome; prospective; simulation; success

SUMMARY Over 200,000 people are treated for out-of-hospital cardiac arrest (OHCA) each year in the United States, and less than 1 in 10 survive with favorable neurologic function. Extracorporeal cardiopulmonary resuscitation (ECPR) using percutaneous veno-arterial extracorporeal circulation (VA-ECMO) is emerging as a potentially effective resuscitation strategy for OHCA patients who fail standard therapy. In published recent case series, survival rates range from 4-33%. Although promising, the efficacy of ECPR for OHCA has yet to be determined in a prospective randomized clinical trial. The overall goal of our research team is to design and perform the first prospective randomized clinical trial to evaluate the efficacy of ECPR for refractory OHCA. The goal of this NHLBI Clinical Trial Pilot Studies application is to generate the preliminary feasibility and efficacy data necessary and sufficient to design a full-scale clinical trial that will provide definitive guidance on the value of ECPR for refractory OHCA. Our first Aim is to demonstrate the efficacy of a training program designed to assure that emergency department providers can rapidly and safely initiate ECPR. Our second Aim is to evaluate the feasibility and performance of an EMS resuscitation strategy incorporating rapid identification and transport of patients with refractory OHCA to an ECPR-capable emergency department. Our third Aim is to evaluate the feasibility and performance of an ED protocol for initiating ECPR in patients with refractory OHCA. Our final Aim is to design and optimize an adaptive clinical trial that will maximize the performance of the planned Phase III multicenter study. The results of these aims will be used to prepare and submit a R01 application for a prospective randomized clinical trial to evaluate the efficacy of ECPR for Refractory Out-of- hospital Cardiac Arrest (EROCA Trial). The potential impact of such a trial is significant. Widespread implementation of ECPR for refractory OHCA could double overall survival rates, saving >10,000 lives each year in the United States. However, emergency medical systems, emergency departments and hospitals need evidence-based guidance regarding the value of implementing this promising but resource intensive therapy. The goal of our team is to provide the essential evidence needed to enable value-based implementation.

概括 在美国，每年有超过 200,000 人因院外心脏骤停 (OHCA) 接受治疗， 只有不到十分之一的患者能够存活并具有良好的神经功能。体外心肺复苏 使用经皮静脉-动脉体外循环（VA-ECMO）的 ECPR（ECPR）正在成为一种潜在的治疗方法。 针对标准治疗失败的 OHCA 患者的有效复苏策略。在最近发布的案例系列中， 存活率范围为 4-33%。尽管前景广阔，但 ECPR 对 OHCA 的疗效仍有待确定 在一项前瞻性随机临床试验中。我们研究团队的总体目标是设计和执行 第一个评估 ECPR 对难治性 OHCA 疗效的前瞻性随机临床试验。此举的目标 NHLBI 临床试验试点研究申请旨在生成初步可行性和疗效数据 设计全面的临床试验是必要且充分的，该试验将为以下方面的价值提供明确的指导： ECPR 用于难治性 OHCA。我们的首要目标是展示培训计划的有效性，该计划旨在 确保急诊科提供者能够快速、安全地启动 ECPR。我们的第二个目标是 评估 EMS 复苏策略的可行性和性能，其中包括快速识别和 将难治性 OHCA 患者转运至具备 ECPR 能力的急诊科。我们的第三个目标是 评估针对难治性 OHCA 患者启动 ECPR 的 ED 方案的可行性和性能。 我们的最终目标是设计和优化适应性临床试验，以最大限度地提高临床试验的性能 计划的 III 期多中心研究。这些目标的结果将用于准备和提交 R01 申请一项前瞻性随机临床试验，以评估 ECPR 对难治性外伤患者的疗效 医院心脏骤停（EROCA 试验）。这种试验的潜在影响是巨大的。广泛 对难治性 OHCA 实施 ECPR 可使总体生存率翻倍，每项可挽救超过 10,000 条生命 年在美国。然而，紧急医疗系统、急诊科和医院需要 关于实施这种有前途但资源密集型疗法的价值的基于证据的指导。 我们团队的目标是提供实现基于价值的实施所需的基本证据。