Transfusion Medicine/Hemostasis Clinical Research Network

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DESCRIPTION (provided by applicant) Core Center Program Objectives: The Pittsburgh Transfusion Medicine/Hemostasis Research Network (PTN); an original and active member of the TMH network seeks to continue to contribute to important multicenter clinical trials in transfusion medicine and hemostasis. We have capitalized on our three strengths in successfully executing the first TMH study (PLADO) and will apply these strengths similarly to t future trials to be conducted by the TMH network. These strengths include: 1) The integrated delivery of transfusion medicine and coagulation services to all the major University of Pittsburgh Medical Center Health System (UPMCHS) hospitals by the University of Pittsburgh faculty at the Institute For Transfusion Medicine (ITxM). 2) The extraordinary patient base afforded by the UPMCHS hospitals including a Pittsburgh Cancer Institute (PCI), adult and pediatric level I trauma centers, a large organ transplant program, a children's hospital, a women's hospital and outpatient facilities including a comprehensive hemophilia center and cancer center. 3) The extensive experience of the investigators and study coordinator in running and/or participating in multicenter clinical trials in transfusion medicine and hemostasis. Specific Aims: The Core Center will provide the infrastructure and oversight necessary for the successful implementation and execution of these trials including: management of the budget for each protocol, administrative support using our established program network office, coordination of resources for the operation of each protocol (eg research nurse, data manager), assure timely implementation and operation of new protocols (eg accrual, data reporting, patient follow up), provide oversight through regular research meetings with protocol investigators, assist protocol investigators with adverse event reporting, data analysis, interpretation, and publication, and work with other network sites to select and revise study protocols. We will meet these objectives by completing our planned enrollment of the PLADO study, initiating enrollment in the SHIP study, and implementing the upcoming TMH clinical studies including but not limited to RICH, CVAD, Granulocyte and STAR. These clinical studies are expected to provide critically important information needed to establish evidence based recommendations for the treatment of patients requiring blood components or patients with hemostatic abnormalities.