The Mass-SIREN Group

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Project Summary/Abstract: This application will continue support for a New England based Network Clinical Center (Hub) for the Strategies to Innovate EmeRgENcy Care Clinical Trials Network (SIREN). We propose to continue our integrated, collaborative team of high-volume tertiary care medical centers with expertise in emergency care clinical research. Our core institutions include Beth Israel Deaconess Medical Center (BIDMC), Boston Children's Hospital (BCH), Boston Medical Center (BMC), Brigham & Women's Hospital (BWH), Dartmouth Hitchcock Medical Center (DHMC), Massachusetts General Hospital (MGH), UMass Memorial Medical Center (UMMMC), and University of Vermont Medical Center (UVM). The team will continue to function administratively as a Hub and Spoke model, but operationally as a collaborative team of medical centers. Specific Aims include: Aim 1: To continue to manage an administrative Hub for the SIREN Clinical Trials Network at Massachusetts General Hospital (MGH). We will continue to coordinate activities with the CCC, our Hub, and Spokes, including attendance at SIREN investigator meetings. Aim 2. To continue to support enrollment in ICECAP at MGH, Yale-New Haven Hospital, and Beth Israel Deaconess Medical Center. We will work to launch Brigham & Women's Hospital as an ICECAP site over the next 6 months. We will work to support enrollment in the Pediatric ICECAP trial and are working with both MGH and Yale-New Haven Hospital to prepare for participation and study launch. Aim 3. To continue to support enrollment in BOOST-3 at MGH, Yale-New Haven Hospital, UMass Medical Center, and Beth Israel Deaconess Medical Center. We will work to launch Brigham & Women's Hospital as a BOOST-3 site over the next 6 months. We will also support enrollment in the BOOST-3 ancillary trials Bio- BOOST and Electro-BOOST. Aim 4: To continue to support submission of novel trials. In coordination with the SIREN CCC, two of our Mass-SIREN investigators are working to submit the KESETT (Ketamine for Status Epilepticus) trial for funding.