This proposal is submitted in response to RFA-HL-06-108 to allow Johns Hopkins to continue to participate in the Transfusion Medicine/ Hemostasis Clinical Trials Network (TMH CTN), a program initiated five years ago in response to RFA-HL-02-001. The proposal is submitted by the Transfusion Medicine Division of the Johns Hopkins Medical Institutions (JHMI) with specific collaborations from the Hematology divisions of the Departments of Medicine and Pediatrics (responsible for the management of sickle cell anemia and hemostatic disorders), and the Hematopoietic and Therapeutic Support service (HATS) (a joint program of the Departments of Pathology and Oncology. The JHMI core clinical center will coordinate the activities of individuals with expertise in transfusion medicine/hemostasis, taking advantage of pre-existing links between the JHMI departments and programs, and utilizing a large and diverse patient base whose therapy is highly dependent upon transfusion and hemostatic therapies. The Hopkins team will participate with 16 other previously selected institutions and the coordinating center of the network (NERI), proposing study protocols and amending protocols suggested by collaborating institutions. In the initial five years of the TMH CTN, we have entered 58 patients into the platelet dosage study (PLADO) and have received IRB approval to initiate enrollment into the SHIP study and the RICH study. We have been active participants at the steering committee and in other committee functions for protocol design and implementation. We have also contributed a number of publications attributed to our JHMI authors and the TMH CTN.
