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 每年在美国，超过20万人接受医院外心脏骤停（OHCA）的治疗， 不到十分之一的神经功能能够生存。体外心肺复苏 （ECPR）使用经皮静脉静脉外循环（VA-ECMO）正在成为潜在的 对于失败标准疗法的OHCA患者的有效复苏策略。在发布的最近案例系列中 生存率范围为4-33％。尽管很有希望，但ECPR对OHCA的功效尚未确定 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 首次前瞻性随机临床试验评估ECPR难治性OHCA的功效。目标的目标 NHLBI临床试验试验研究的应用是生成初步的可行性和功效数据 必要且足够的设计全尺度临床试验，该试验将提供有关价值的明确指导 ECPR用于难治性OHCA。我们的第一个目的是证明旨在的培训计划的功效 确保急诊室提供商可以快速安全地启动ECPR。我们的第二个目标是 评估EMS复苏策略的可行性和性能，该策略结合了快速识别和 将难治性OHCA患者运输到具有ECPR能力的急诊科。我们的第三个目标是 评估ED方案在难治性OHCA患者中启动ECPR的可行性和性能。 我们的最终目的是设计和优化一项自适应临床试验，该试验将最大程度地发挥作用 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 应用前瞻性随机临床试验，以评估ECPR对难治性的效力 医院心脏骤停（EROCA试验）。这种试验的潜在影响很大。广泛 ECPR实施难治性OHCA的总生存率可以两倍 在美国。但是，紧急医疗系统，急诊科和医院需要 关于实施这种有希望但资源密集型疗法的价值的循证指导。 我们团队的目标是提供实现基于价值实施的必要证据。