The Transfusion Medicine/Hemostasis Clinical Trials Network (TMH Network) was established in October 2002 to conduct large multi-institutional clinical trials.This Network will promote the efficient comparison of novel management strategies of potential benefit for children and adults with hemostatic disorders. The trials will address areas such as hemophilia, idiopathic thrombocytopenia purpura (ITP) and thrombotic thrombocytopenic purpura (TTP) and will evaluate new as well as existing blood products and cytokines for the treatment of hematologic disorders.

Background

In recent years, there have been numerous advances in the world of transfusion medicine and hematology, however, an urgent need remains to evaluate new blood products and promising new therapies for hemostatic disorders. Functioning clinical networks in Europe have fostered the collaborative approach to clinical problems and have been relatively successful. Similar networks for studies in the areas of transfusion medicine/hemostasis are not available in the U.S. There are several reasons why a Transfusion Medicine/Hemostasis Clinical Research Network would accelerate clinical research and translation of research to practice. Multi-center trials will reduce the number of patients needed at each clinical center and allow accrual to be completed more rapidly. Further, a common treatment protocol will reduce variables that contribute to patient outcome and allow valid comparisons between treatments.

The objective of a Transfusion Medicine/Hemostasis Clinical Research Network will be to standardize approaches to existing diagnoses and treatments, and evaluate new ones. The emphasis will be on clinical trials with a goal toward facilitating optimal therapy. Therapeutic trials may involve investigational drugs or blood products, including those already approved but not currently used, and those currently used. The Network will emphasize the strength of the close collaborations between experts in transfusion medicine and those in hemostasis (and hematology) to potentially explore the role for other blood derived products.

The treatment of patients with hemostatic disorders that are congenital in origin (e.g., hemophilia A), immune mediated (e.g., idiopathic thrombocytopenic purpura or thrombotic thrombocytopenic purpura) or due to coagulopathies resulting from chemotherapy, surgery, or trauma all require collaboration between physicians who are specialized in transfusion medicine and those with specialized knowledge of hemostasis. For some of the relatively rare disorders, new treatments are available; they may be extremely costly and may not have been compared to other less costly but effective agents. Without systematic studies, the best choices of treatment for specific patients cannot be made.