Transfusion Medicine/Hemostasis Clinical Research Network

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DESCRIPTION (provided by applicant) This application responds to RFA-HL-06-108 entitled "Announcement of a Limited Competition for the Continuation of the Transfusion Medicine/Hemostasis Clinical Trials Network" (TMH CTH) (U01). Clinical issues in transfusion medicine and hemostasis often deal with a large number of relatively uncommon diseases. It has been difficult to answer clinical questions about specific areas of transfusion medicine/hemostasis due to the lack of a critical number of patients at any given institution. The TMH Network was established in 2002, composed of 17 core centers recognized as being leaders in this field of medicine. It is a national resource assigned with the purpose of advancing knowledge and understanding in the area of transfusion medicine and hemostasis. The Network has promoted the comparison of novel management strategies of potential benefit for children and adults with hemostatic disorders and has evaluated novel as well as existing blood therapies and cytokines for the treatment of hematologic disorders. The emphasis over the last 4 years has been on identifying areas of transfusion medicine/hemostasis that need to be scientifically explored, developing research protocols with a goal toward facilitating optimal therapy, initiating clinical trials, and moving towards completion and data analysis. Therapeutic trials have involved the use of investigational drugs or blood products, including those already approved and used, as well as those not currently used. The Network emphasizes the strength of the close collaboration between experts in transfusion medicine and hematology to potentially explore the role for other blood derived products, such as granulocytes. Three research studies have been approved by the Protocol Review Committee and DSMB (PLADO, SHIP and RICH) and are currently being conducted at participating centers or are on the verge of initiating clinical trials. The Network has a pipeline of several other studies that are close to being activated (HIT, Granulocyte Study, CVAD, STAR). Each year, thousands of patients receive treatment for diseases like "FTP and Hemophilia. Many millions more have problems with thrombocytopenia, neutropenia and anemia. This network has established a building block for future research to help treat and combat these problems. UNIVERSITY OF IOWA CRITIQUES