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.

Condition	Treatment or Intervention
Purpura, Thrombocytopenic Blood Disease	Procedure: Blood Platelet Transfusions

Further Study Details: 

BACKGROUND: 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: Determination of the Optimal Prophylactic Platelet Dose Strategy to Prevent Bleeding in Thrombocytopenic Patients: This study is in recruitment and is expected to accrue 1,350 patients.

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. The study will be activated in early 2005.

The following two protocols are under development: 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.

Helicobacter Pylori Eradication in Idiopathic Thrombocytopenic Purpura.

Genders Eligible for Study:  Male

Criteria

No eligibility criteria

Georgia
      Emory University, Atlanta,  Georgia,  30322,  United States; Recruiting
Iowa
      University of Iowa College of Medicine, Iowa City,  Iowa,  52242,  United States; Recruiting
Louisiana
      Tulane University, New Orleans,  Louisiana,  70112-2699,  United States; Recruiting
Maryland
      Johns Hopkins University, Baltimore,  Maryland,  21287,  United States; Recruiting
      University of Maryland at Baltimore, Baltimore,  Maryland,  21201,  United States; Recruiting
Massachusetts
      Massachusetts General Hospital, Boston,  Massachusetts,  02114-2554,  United States; Recruiting
      Children's Hospital, Boston, Boston,  Massachusetts,  02115,  United States; Recruiting
Minnesota
      University of Minnesota Twin Cities, Minneapolis,  Minnesota,  55455,  United States; Recruiting
New York
      Weill Medical College of Cornell University, New York,  New York,  10021,  United States; Recruiting
North Carolina
      University of North Carolina, Chapel Hill,  North Carolina,  27599,  United States; Recruiting
      Duke University, Durham,  North Carolina,  27710,  United States; Recruiting
Ohio
      Case Western Reserve University, Cleveland,  Ohio,  44106-4937,  United States; Recruiting
Oklahoma
      University of Oklahoma Health Sciences Center, Oklahoma City,  Oklahoma,  73190,  United States; Recruiting
Pennsylvania
      University of Pittsburgh, Pittsburgh,  Pennsylvania,  15261,  United States; Recruiting
      University of Pennsylvania, Philadelphia,  Pennsylvania,  19104,  United States; Recruiting
Washington
      Puget Sound Blood Center, Seattle,  Washington,  98104-1256,  United States; Recruiting
Wisconsin
      Blood Center of Southeastern Wisconsin, Milwaukee,  Wisconsin,  53201-2178,  United States; Recruiting

Study chairs or principal investigators

Donald Bambilla,  New England Research Institute, Inc.   
Mark Brecher,  University of North Carolina   
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   

Study ID Numbers:  144
Record last reviewed:  March 2005
Last Updated:  April 1, 2005
Record first received:  April 19, 2004
ClinicalTrials.gov Identifier:  NCT00081718
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08