The continuing evolution in medical care, adoption of high technology therapies, and advances in blood banking technology have led to innovations in transfusion therapy. Wise decisions about the use of novel blood products and the management of hemostatic disorders has created a need for a national clinical trials network to evaluate new therapies. A Transfusion Medicine and Hemostasis (TMH) Clinical Trials Network (CTN) was established in 2002. The principal investigators and their collaborators at the 17 funded sites, have worked successfully to develop and implement clinical trials in transfusion medicine and hemostasis. Protocols presently active include platelet dose (PLADO), use of fresh frozen plasma (SHIP), and those soon to be initiated are: granulocyte transfusion, an observational study of thrombosis in heparin induced thrombocytopenia, and rituximab for inhibitors in hemophilia. Several others are less developed. The University of Minnesota has a long history of successful transfusion medicine and hemostasis clinical trials. There is an excellent productive relationship between key clinical services and hemostasis and transfusion medicine faculty. The resources to successfully produce novel blood products or to provide new therapies for hemostatic conditions are available through our Molecular and Cellular Facility and Cell Therapy Laboratory the hospital blood bank and through excellent relationships with traditional blood suppliers. Therefore we propose to continue to participate in the Transfusion Medicine and Hemostasis Clinical Trials Network to continue to address important clinical issues that need scientific study in a multi-center network. Over the next the 5 years, as part of the TMH CTN we propose to participate in the network to: Maintain, and further enhance, a structure to support the development, implementation and conduct of clinical trials in the areas of transfusion medicine and hemostasis. Utilize the structure of working and study oversight subcommittees to complete ongoing trials and develop, refine and complete new trials proposed in this application. Develop collaborative relationships and support training opportunities to facilitate the success of the proposed clinical trials and further the fields of transfusion medicine and hemostasis. Disseminate results of the TMH CTN through presentation and publication of clinical trial results and other TMH CTN activities.
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