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

项目摘要 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 现有的研究网络将引领应急创新战略的成功招生中心 关怀临床试验网络(SIREN)。OHSU具有管理多站点ED和EMS的特定经验 作为NIH/NHLBI复苏结果联盟(ROC)十个区域招募中心之一的研究 NIH/NINDS神经紧急治疗试验(NETT)的22个登记中心之一 财团。OHSU SIREN研究小组包括首席调查人员、合作调查人员和研究/数据 OHSU中华民国和NETT枢纽的经理。我们的教员团队成员都是联邦政府资助的临床 科学家们，其中包括NIH在2015年资助的前十名DEM调查人员中的两名。我们有超过100个人年 具有在EMS和ED环境下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研究的经验和我们研究团队的领导：目标1.创建警报器 招生网实现年招生人数至少100人。1A.构建ED辐条 网络。我们建议八个具有以下条件的辐条：1.三级医疗临床基础设施 支持所有SIREN试验；2.ED研究招生的良好历史；3.先前存在的研究合作 和OHSU警报队一起。我们的网络提供高容量和多样化的服务(按种族、民族、付款人) 在过去的两年里，已经招募了14,000名患者。1B.建设EMS网络。对于Out- 医院警报研究，我们将继续使用我们创建的广泛的区域EMS研究网络 通过我们的中华民国和NETT经验。这包括18个EMS机构和14家接收医院 通过ROC和NETT招募了约2000名患者。1C。组建专科专家小组。我们在此基础上 ROC、NETT和其他多项合作紧急护理研究，包括麻醉学专家， 心脏病学、心胸外科、重症监护、急诊内科、血液学、神经病学、神经外科 和创伤手术。目标2.促进国家警报网的治理和科学工作。2A。 参与警报器治理工作。我们的警报器研究团队成员在 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委员会和出版物委员会。我们会 继续对警报网进行类似的治理委员会参与。2B。引领警报器的科学努力。 我们曾领导中华民国写作小组，担任中华民国审判的推动者，并与人合著40份中华民国报告。我们 预计将对警报器做出类似的贡献。我们提出了两个SIREN试验(低血压创伤 复苏，改良气管插管)。综上所述，OHSU拥有机构经验、学习团队 领导力，以及先前存在的ED和EMS研究网络，以领导一个成功的警报器枢纽。

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.