Clinical Trial: Transfusion Medicine/Hemostasis Clinical Research Network

This study is currently recruiting patients.

Sponsored by: National Heart, Lung, and Blood Institute (NHLBI)
Information provided by: National Heart, Lung, and Blood Institute (NHLBI)


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

MedlinePlus related topics:  Bleeding Disorders;   Blood and Blood Disorders;   Immune System and Disorders

Study Type: Interventional
Study Design: Treatment

Further Study Details: 

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


No eligibility criteria

Location and Contact Information

      Emory University, Atlanta,  Georgia,  30322,  United States; Recruiting
Christopher D. Hillyer, M.D.,  404-712-5869    CHILLYE@EMORY.EDU 
Christopher D. Hillyer,  Study Chair

      University of Iowa College of Medicine, Iowa City,  Iowa,  52242,  United States; Recruiting
Ronald G. Strauss, M.D.  319-356-0387    RONALD-STRAUSS@UIOWA.EDU 
Ronald G. Strauss,  Study Chair

      Tulane University, New Orleans,  Louisiana,  70112-2699,  United States; Recruiting
Cindy A. Leissinger, M.D.  504-588-5433    CLEISSI@TULANE.EDU 
Cindy A. Leissinger,  Study Chair

      Johns Hopkins University, Baltimore,  Maryland,  21287,  United States; Recruiting
Paul M. Ness, M.D.  410-955-6583    PNESS@JHMI.EDU 
Paul M. Ness,  Study Chair

      University of Maryland at Baltimore, Baltimore,  Maryland,  21201,  United States; Recruiting
John R. Hess, M.D.  410-328-3834    JHESS@UMM.EDU 
John R. Hess,  Study Chair

      Massachusetts General Hospital, Boston,  Massachusetts,  02114-2554,  United States; Recruiting
David J. Kuter, M.D.  617-726-3906    KUTER.DAVID@MGH.HARVARD.EDU 
David J. Kuter,  Study Chair

      Children's Hospital, Boston, Boston,  Massachusetts,  02115,  United States; Recruiting
Ellis J. Neufeld, M.D.  617-355-8183    ELLIS.NEUFELD@CHILDRENS.HARVARD.EDU 
Ellis J. Neufeld,  Study Chair

      University of Minnesota Twin Cities, Minneapolis,  Minnesota,  55455,  United States; Recruiting
Jeffrey McCullough, M.D.  612-626-3772    MCCUL001@UMN.EDU 
Jeffrey McCullough,  Study Chair

New York
      Weill Medical College of Cornell University, New York,  New York,  10021,  United States; Recruiting
James B. Bussel  212-746-3474    JBUSSEL@MED.CORNELL.EDU 
James B. Bussel,  Study Chair

North Carolina
      University of North Carolina, Chapel Hill,  North Carolina,  27599,  United States; Recruiting
Mark Brecher, M.D.  919-966-8465 
Mark Brecher,  Study Chair

      Duke University, Durham,  North Carolina,  27710,  United States; Recruiting
Thomas L. Ortel, M.D.  919-684-5350    ORTE1001@MC.DUKE.EDU 
Thomas L. Ortel,  Study Chair

      Case Western Reserve University, Cleveland,  Ohio,  44106-4937,  United States; Recruiting
Keith McCrae, M.D.  216-368-1175    KXM71@PO.CWRU.EDU 
Keith R. McCrae,  Study Chair

      University of Oklahoma Health Sciences Center, Oklahoma City,  Oklahoma,  73190,  United States; Recruiting
James N. George, M.D.  405-271-4222    JIM-GEORGE@OUHSC.EDU 
James N. George,  Study Chair

      University of Pittsburgh, Pittsburgh,  Pennsylvania,  15261,  United States; Recruiting
Darrell J. Triulzi, M.D.  412-209-7304    DTRIULZI@ITXM.ORG 
Darrell J. Triulzi,  Study Chair

      University of Pennsylvania, Philadelphia,  Pennsylvania,  19104,  United States; Recruiting
Barbara A. Konkle, M.D.  215-662-9248    KONKLEB@MAIL.MED.UPENN.EDU 
Barbara A. Konkle,  Study Chair

      Puget Sound Blood Center, Seattle,  Washington,  98104-1256,  United States; Recruiting
Sherrill J. Slichter, M.D.  206-292-6541    SJSLICHTER@PSBC.ORG 
Sherrill J. Slichter,  Study Chair

      Blood Center of Southeastern Wisconsin, Milwaukee,  Wisconsin,  53201-2178,  United States; Recruiting
Janice G. Mc Farland, M.D.  414-937-6215 
Janice G. Mc Farland,  Study Chair

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   

More Information

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

Cache Date: April 9, 2005