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

创新紧急护理临床试验网络 (SIREN) 的策略 - 网络临床中心（中心）

• 批准号: 10200904
• 负责人: MOHAMUD RAMZANALI DAYA
• 金额: $ 15.09万
• 依托单位: OREGON HEALTH & SCIENCE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-07-15 至 2023-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10200904
• 关键词: Accident and Emergency department; Acute; Anesthesia procedures; Anesthesiology; Antihypertensive Agents; Cardiac; Cardiology; Centers for Disease Control and Prevention (U.S.); Clinical; Clinical Trials Network; Collaborations; Contracts; Coronary; Creatine Kinase MB Isoenzyme; Critical Care; Data; Development; Disclosure; Electric Countershock; Emergency Care; Emergency Medicine; Emergency Situation; Emergency medical service; Emergency research; Enrollment; Ethnic Origin; Evaluation; Event; Faculty; Funding; Health Sciences; Health Services Research; Heart Arrest; Hematology; Hemorrhage; Hospitals; Informed Consent; Institutional Review Boards; Lead; Leadership; Methods; Monitor; Multi-Institutional Clinical Trial; Myocardial Ischemia; National Heart, Lung, and Blood Institute; National Institute of Neurological Disorders and Stroke; Neurologic; Neurological emergencies; Neurology; Operative Surgical Procedures; Oregon; Outcome; Participant; Patient-Focused Outcomes; Patients; Performance; Persons; Physicians; Population; Positioning Attribute; Principal Investigator; Procedures; Publications; Race; Recording of previous events; Reporting; Research; Research Personnel; Resuscitation; Rural; Science; Scientist; Service setting; Site; Syncope; Toxicology; Translational Research; Trauma; Tube; United States Agency for Healthcare Research and Quality; United States National Institutes of Health; Universities; Work; Writing; acute care; clinical center; clinical infrastructure; community consultation; cost; data exchange; data management; endotracheal; experience; improved outcome; innovation; member; neurosurgery; payment; pediatric emergency; recruit; remediation; respiratory; risk stratification; tertiary care; trauma care; trauma surgery; treatment trial

Oregon Health & Science University (OHSU) has the institutional experience, study team leadership, and pre- existing 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 person- years 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 receiving 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.

俄勒冈州健康与科学大学（OHSU）具有机构经验，研究团队领导，和预 现有的研究网络，以领导一个成功的招生中心的战略，以创新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。我们有100多人- 在EMS和艾德环境中进行多站点研究的多年综合经验。我们利用我们 多中心艾德/ EMS研究的丰富经验和我们的研究团队领导，以： 目标1。创建SIREN注册网络，每年至少注册100名参与者。 1a.构建艾德辐条网络。我们提出八个辐条，具有以下资格：1. 支持所有SIREN试验的三级护理临床基础设施; 2.艾德研究招募的强大历史; 3.与OHSU SIREN团队已有的研究合作。我们的网络提供高容量和 多样化（按种族、民族、付款人）人群，在过去两年中招募了14，000多名患者。 1b.构建EMS网络。对于院外SIREN研究，我们将继续使用我们广泛的 通过我们的ROC和NETT经验创建的区域EMS研究网络。其中包括18个EMS 这些机构和14家接收医院通过ROC和NETT招募了约2,000名患者。 1c.建立一个专科专家小组。我们建立在ROC，NETT和其他多个合作伙伴的基础上， 紧急护理研究，包括麻醉学，心脏病学，心胸外科，关键 护理、急诊医学、血液学、神经病学、神经外科和创伤外科。 目标2.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研究团队成员已经领导了 ROC/NETT委员会的职位，包括执行、创伤、心脏、监管、EMS和 出版物。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。我们领导过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 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既存的艾德和EMS 研究网络，以领导一个成功的SIREN枢纽。