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

摘要 在美国，每年有20多万人因院外心脏骤停而接受治疗， 只有不到十分之一的人存活下来，并具有良好的神经功能。体外循环心肺复苏 (ECPR)使用经皮动静脉-动脉体外循环(VA-ECMO)正在成为一种潜在的 对于未通过标准治疗的患者，有效的复苏策略。在最近出版的案例系列中， 存活率从4%到33%不等。尽管ECPR很有希望，但它的疗效仍有待确定 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 首次前瞻性随机临床试验评价ECPR治疗难治性肝细胞癌的疗效。这样做的目的是 NHLBI临床试验先导研究的应用是生成初步的可行性和有效性数据 设计一项全面的临床试验是必要和充分的，该试验将提供关于 ECPR治疗难治性心肌梗死。我们的第一个目标是证明一项旨在 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绩效，其中包括快速识别和 将难治性心肌梗死患者送往具有ECPR能力的急诊科。我们的第三个目标是 评估ED方案在难治性心肌梗死患者中启动心肺复苏的可行性和有效性。 我们的最终目标是设计和优化适应性临床试验，使 计划中的第三阶段多中心研究。这些AIMS的结果将用于准备和提交R01 一项前瞻性随机临床试验在评价ECPR治疗难治性出院疗效中的应用 医院心脏骤停(EROCA试验)。这种审判的潜在影响是巨大的。广为传播 对难治性心肌梗死实施ECPR可将总体存活率提高一倍，每人挽救1万人的生命 在美国的一年。然而，急救医疗系统、急诊科和医院需要 关于实施这一前景看好但资源密集的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的实施所需的基本证据。

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.