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

项目摘要 俄勒冈州健康与科学大学（OHSU）拥有机构经验，研究团队领导， 现有的研究网络，以领导一个成功的招生中心的战略创新EmeRgENcy 护理临床试验网络（SIREN）。OHSU具有管理多站点艾德和EMS的具体经验 研究作为NIH/ NHLBI复苏结果联盟（ROC）的十个区域注册中心之一 以及NIH/ NINDS神经系统紧急治疗试验（NETT）的22个注册中心之一 财团OHSU SIREN研究团队包括主要研究者、合作研究者和研究/数据 OHSU ROC和NETT中心的经理。我们的教师团队成员都是联邦资助的临床 科学家，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和艾德环境中进行多地点研究的综合经验。我们利用我们广泛的 拥有多地点艾德/ EMS研究的经验以及我们的研究团队领导力：目标1。创建警报 注册网络，以实现每年至少100名参与者的注册。1a.构建艾德轮辐 网络我们提出八个辐条，具有以下资格：1.三级医疗临床基础设施 支持所有SIREN试验; 2.艾德研究招募的强大历史; 3.现有的研究合作 OHSU Siren团队我们的网络提供高容量和多样化（按种族，民族，付款人） 在过去的两年里，已经招募了超过14，000名患者。1b.构建EMS网络。为了- 医院SIREN研究，我们将继续使用我们广泛的区域EMS研究网络创建 通过我们的ROC和NETT经验。这包括18个EMS机构和14个接收医院， 通过ROC和NETT入组约2，000例患者。1c.建立一个专科专家小组。我们建立在 ROC，NETT和其他多个合作紧急护理研究，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、神经病学、神经外科， 和创伤手术目标二。促进国家SIREN网络的管理和科学工作。2a. 参与SIREN治理工作。我们的SIREN研究团队成员曾担任领导职务， ROC/NETT委员会，包括执行委员会、创伤委员会、心脏委员会、法规委员会、EMS委员会和出版委员会。我们将 继续类似的治理委员会参与SIREN网络。2b.领导SIREN的科学工作。 我们领导了ROC写作小组，担任ROC试验的促进者，并共同撰写了超过40份ROC报告。我们 期待为SIREN做出类似的贡献。我们提出了两个SIREN试验（低血压创伤 复苏，改良气管插管）。总之，OHSU拥有机构经验，研究团队 领导力，以及预先存在的艾德和EMS研究网络，以领导一个成功的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.