Strategies to Innovate EmeRgENcy Care Clinical Trials Network (SIREN) - Network Clinical Center (Hub)

项目概要 俄勒冈健康与科学大学 (OHSU) 拥有机构经验、研究团队领导力和 现有的研究网络将领导一个成功的招生中心，以实施创新应急战略 护理临床试验网络 (SIREN)。 OHSU 拥有管理多站点 ED 和 EMS 的具体经验 作为 NIH/NHLBI 复苏结果联盟 (ROC) 十个区域招募中心之一的研究 以及 NIH/NINDS 神经紧急治疗试验 (NETT) 22 个招募中心之一 财团。 OHSU SIREN 研究团队包括主要研究人员、共同研究人员和研究/数据 OHSU ROC 和 NTT 中心的经理。我们的教职团队成员都是联邦政府资助的临床 科学家，其中包括 2015 年 NIH 资助的前 10 名 DEM 研究人员中的两名。我们每年有超过 100 人 在 EMS 和 ED 环境中进行多站点研究的综合经验。我们利用我们广泛的 多站点 ED/EMS 研究经验和我们的研究团队领导力旨在： 目标 1. 创建 SIREN 招生网络实现每年至少招生100名参与者。 1a.构建 ED 辐条 网络。我们提出了八个具有以下资格的辐条： 1. 三级护理临床基础设施 支持所有 SIRN 试验； 2. ED 研究招生的悠久历史； 3. 已有的研究合作 与 OHSU Siren 团队合作。我们的网络服务量大且多样化（按种族、民族、付款人） 人口，并在过去两年招募了超过 14,000 名患者。 1b.构建EMS网络。对于出- 院外 SIREN 研究，我们将继续使用我们创建的广泛区域 EMS 研究网络 通过我们的 ROC 和 NTT 经验。其中包括 18 家 EMS 机构和 14 家接收医院 通过 ROC 和 NTT 招募了约 2,000 名患者。 1c.组建专科专家组。我们建立在 ROC、NETT 和多个其他协作紧急护理研究，包括麻醉学专家、 心脏病学、心胸外科、重症监护、急诊医学、血液学、神经内科、神经外科、 和创伤手术。目标 2. 为国家 SIREN 网络的治理和科学工作做出贡献。 2a. 参与 SIREN 治理工作。我们的 SIREN 研究团队成员在以下领域担任过领导职务： ROC/NETT 委员会，包括执行委员会、创伤委员会、心脏委员会、监管委员会、EMS 委员会和出版委员会。我们会 继续参与 SIREN 网络的类似治理委员会。 2b.引领 SIRN 科学努力。 我们领导过 ROC 写作小组，担任 ROC 试验的协调人，并与人共同撰写了超过 40 份 ROC 报告。我们 预计会对 SIREN 做出类似的贡献。我们提出两项 SIREN 试验（低血压创伤 复苏，改良气管插管）。综上所述，OHSU拥有机构经验、研究团队 领导力以及现有的 ED 和 EMS 研究网络来领导一个成功的 SIREN 中心。

Project Summary Oregon Health & Science University (OHSU) has the institutional experience, study team leadership, and preexisting research networks to lead a successful enrollment hub for the Strategies to Innovate EmeRgENcy Care Clinical Trials Network (SIREN). OHSU has specific experience managing multisite ED and EMS research as one of ten regional enrolling hubs for the NIH/ NHLBI Resuscitation Outcomes Consortium (ROC) and one of 22 enrolling hubs for the NIH/ NINDS Neurological Emergency Treatment Trials (NETT) consortium. The OHSU SIREN study team includes principal investigators, co-investigators, and study/ data managers for the OHSU ROC and NETT hubs. Our faculty team members are all federally funded clinical scientists and include two of the top 10 NIH funded DEM investigators in 2015. We have over 100 personyears of combined experience conducting multi-site research in EMS and ED settings. We leverage our extensive experience with multisite ED/ EMS research and our study team leadership to: Aim 1. Create a SIREN enrollment network to achieve an annual enrollment of at least 100 participants. 1a. Construct an ED Spoke Network. We propose eight spokes that have the following qualifications: 1. Tertiary -care clinical infrastructure to support all SIREN trials; 2. Strong history of ED research enrollment; 3. Pre -existing research collaborations with the OHSU SIREN team. Our network serves a high volume and diverse (by race, ethnicity, payer) population, and has enrolled >14,000 patients in the past two years. 1b. Construct an EMS Network. For out- of-hospital SIREN studies, we will continue to use our extensive regional EMS research network created through our ROC and NETT experiences. This includes 18 EMS agencies and 14 r eceiving hospitals that have enrolled ~2,000 patients through ROC and NETT. 1c. Construct a Subspecialty Expert Panel. We build on ROC, NETT and multiple other collaborative emergency care research to include experts in anesthesiology, cardiology, cardiothoracic surgery, critical care, emergency medicine, hematology, neurology, neurosurgery, and trauma surgery. Aim 2. Contribute to governance and scientific efforts of the national SIREN network. 2a. Participate in SIREN governance efforts. Our SIREN study team members have held leadership positions on ROC/NETT committees, including Executive, Trauma, Cardiac, Regulatory, EMS, and Publications. We will continue similar governance committee participation for the SIREN network. 2b. Lead SIREN scientific efforts . We have led ROC writing groups, served as facilitators for ROC trials, and co-authored >40 ROC reports. We anticipate making similar contributions to SIREN. We propose two SIREN trials (Hypotensive Trauma Resuscitation, Modified Endotracheal Tubes). In summary, OHSU has the institutional experience, study team leadership, and pre-existing ED and EMS research networks to lead a successful SIREN hub.