Transfusion Medicine/Hemostasis Clinical Research Network

To establish a clinical network which will promote the efficient comparison of new management strategies of potential benefit for children and adults with hemostatic disorders such as idiopathic thrombocytopenia (ITP) and thrombotic thrombocytopenic purpura (TTP). The network also will evaluate new as well as existing blood products and cytokines for the treatment of hematologic disorders.

Official Title

Transfusion Medicine/Hemostasis Clinical Research Network

Conditions

Purpura, ThrombocytopenicBlood Disease

Study Type

Interventional

Study Design

Treatment

Further Details

Expected completion: August 2007BACKGROUND: Clinical issues in transfusion medicine/hemostasis are sometimes focused on a large number of relatively rare diseases. For this reason, it is difficult to answer clinical questions of note due to the lack of a critical number of patients at any given institution. The NHLBI Workshop on Development of New Therapies for Rare Blood Diseases held on July 14, 1999 and a Working Group on Clinical Research in Transfusion Medicine/Hemostasis that was convened on August 18, 2000 recommended the facilitation of clinical trials in this area with increased links to regulatory agencies such that therapeutic development could be fostered. Functioning clinical networks in Europe have fostered the collaborative approach to clinical problems and have been relatively successful.There is an urgent need to evaluate promising new therapies for hemostatic disorders such as idiopathic thrombocytopenic purpura (ITP) and thrombotic thrombocytopenic purpura (TTP) and to evaluate new blood products, especially platelets and platelet substitutes, and cytokines such as thrombopoietin. Each year, thousands of patients receive platelet transfusions or are treated for autoimmune hemostatic disorders and yet few have the opportunity to participate in clinical trials that would potentially result in improved patient care. 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. Finally, the Network approach will increase the number of comparative trials that are conducted by providing a framework for rapid initiation of important studies, a focus on randomized studies, and efficient use of pooled clinical expertise and data management resources.DESIGN NARRATIVE: Several protocols under development involve new treatments for idiopathic thrombocytopenia (ITP) and thrombotic thrombocytopenic purpura (TTP). The first protocol for implementation is titled “Determination of the Optimal Prophylactic Platelet Dose Strategy to Prevent Bleeding in Thrombocytopenic Patients”. New amd existing blood products and cytokines will also be evaluated for the treatment of blood disorders. Seventeen core clinical centers will perform multiple clinical trials.The Study of Hemostasis and Invasive Procedures (SHIP) is currently under development. SHIP is a multicenter, randomized, controlled trial of fresh, frozen plasma or recombinant activated factor VII or no therapy prior to invasive hepatobiliary procedures.Rituximab for the Treatment of Patients with Congenital Hemophilia and High Titer Inhibitors.Granulocyte-Colony Stimulating Factor (G-CSF)/Dexamethasone Mobilized Granulocyte Transfusions for the Treatment of Serious Bacterial and Fungal Infections in Neutropenic Patients After Chemotherapy or Hematopoietic Transplantation.

Study Start

Study start: September 2002

Eligibility & Criteria

Total Enrolment

Contact Details

Donald Bambilla, New England Research Institute, Inc. James Bussel, Cornell University Medical College James George, University of Oklahoma Health Sciences Center John Hess, University of Maryland at Baltimore Christopher Hillyer, Emory University Barbara Konkle, University of Pennsylvania David Kuter, Massachusetts General Hospital Cindy Leissinger, Tulane University Janice Mc Farland, Blood Center of Southeastern Wisconsin Keith McCrae, Case Western Reserve University Jeffrey McCullough, University of Minnesota Twin Cities Paul Ness, Johns Hopkins University Ellis Neufeld, Children’s Hospital Boston Thomas Ortel, Duke University Sherrill Slichter, Puget Sound Blood Center Ronald Strauss, University of Iowa Darrell Triulzi, University of Pittsburgh Gilbert White, University of North Carolina