Transfusion Medicine/Hemostasis Clinical Research Network - Article Botanicals; Herbalism; Medicinal Herbs
Clinical Trial: Transfusion Medicine/Hemostasis Clinical Research Network
This study is currently recruiting patients.
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 |
| Procedure: Blood Platelet Transfusions |
MedlinePlus related topics: Bleeding Disorders; Blood and Blood Disorders; Immune System and Disorders
Study Type: Interventional
Study Design: Treatment
Study start: September 2002; Expected completion: August 2007
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
Location and Contact Information
Emory University, Atlanta, Georgia, 30322, United States; Recruiting
Christopher D. Hillyer, Study Chair
University of Iowa College of Medicine, Iowa City, Iowa, 52242, United States; Recruiting
Ronald G. Strauss, Study Chair
Tulane University, New Orleans, Louisiana, 70112-2699, United States; Recruiting
Cindy A. Leissinger, Study Chair
Johns Hopkins University, Baltimore, Maryland, 21287, United States; Recruiting
Paul M. Ness, Study Chair
University of Maryland at Baltimore, Baltimore, Maryland, 21201, United States; Recruiting
John R. Hess, Study Chair
Massachusetts General Hospital, Boston, Massachusetts, 02114-2554, United States; Recruiting
David J. Kuter, Study Chair
Children's Hospital, Boston, Boston, Massachusetts, 02115, United States; Recruiting
Ellis J. Neufeld, Study Chair
University of Minnesota Twin Cities, Minneapolis, Minnesota, 55455, United States; Recruiting
Jeffrey McCullough, Study Chair
Weill Medical College of Cornell University, New York, New York, 10021, United States; Recruiting
James B. Bussel, Study Chair
University of North Carolina, Chapel Hill, North Carolina, 27599, United States; Recruiting
Mark Brecher, Study Chair
Duke University, Durham, North Carolina, 27710, United States; Recruiting
Thomas L. Ortel, Study Chair
Case Western Reserve University, Cleveland, Ohio, 44106-4937, United States; Recruiting
Keith R. McCrae, Study Chair
University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, 73190, United States; Recruiting
James N. George, Study Chair
University of Pittsburgh, Pittsburgh, Pennsylvania, 15261, United States; Recruiting
Darrell J. Triulzi, Study Chair
University of Pennsylvania, Philadelphia, Pennsylvania, 19104, United States; Recruiting
Barbara A. Konkle, Study Chair
Puget Sound Blood Center, Seattle, Washington, 98104-1256, United States; Recruiting
Sherrill J. Slichter, Study Chair
Blood Center of Southeastern Wisconsin, Milwaukee, Wisconsin, 53201-2178, United States; Recruiting
Janice G. Mc Farland, Study Chair
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
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
Cache Date: April 9, 2005