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

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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.