With this application, the Transfusion Medicine Program, Emery University seeks to become a Core Clinical Center within the proposed network. As a Core Clinical Center, we will contribute scientific concepts and protocol development; participate in the overall administration of the clinical trials through the national Steering Committee and Data Coordinating Center; adhere to national and institutional guidelines and regulatory requirements related to research involving human subjects; accrue eligible patients to trials selected to be conducted by the Network; and disseminate findings through timely publications and presentations of data. The complex and significant research questions related to TM/hemostasis require clinical studies to evaluate developmental concepts through to ultimate testing of new strategies compared to the standard-of-care through large-scale, controlled trials, necessitating the development of such a proposed network. As a Core Clinical Center of the Clinical Research Network we will pursue the following Specific Aims, to: 1) investigate significant questions in transfusion medicine practice; 2) evaluate novel management strategies in hemostatic and hematologic disorders in both pediatric and adult settings; and 3) establish the programmatic infrastructure and systems to ensure multidisciplinary, multi-center interactions, data quality/analysis, and efficient, timely accrual to trials. In this proposal we provide evidence of our institutional and individual expertise in multi-center clinical trials, as well as documentation of access to relevant patient populations, volume of blood/blood products collected and infused, and multidisciplinary interaction in the Core Clinical Center. Further evidence of our expertise is provided through the inclusion of two proposed model clinical protocols, both randomized trials, investigating important clinical questions in transfusion medicine and hemostasis. The expertise of the multidisciplinary investigators; access to significant numbers of cases with conditions that potentially would be eligible for prospective studies in Transfusion Medicine and/or Hemostasis; excellent organization for clinical trial implementation and data management; innovative concepts for development of possible trials; and national leadership in Transfusion Medicine as well as hemostasis and thrombosis provide the basis for Emery University's efforts to participate as a core member of the NHLBI clinical network in TM/Hemostasis.
