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Home > "T" Clinical Trials Conditions > Transfusion Medicine/Hemostasis Clinical Research Network  Transfusion Medicine/Hemostasis Clinical Research Network
Transfusion Medicine/Hemostasis Clinical Research Network
For Condition: Purpura, Thrombocytopenic,Blood Disease
Status: Not yet recruiting
Sponsor(s): National Heart, Lung, and Blood Institute (NHLBI) ,
Synopsis: 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.
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: 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. H. Pylori Eradication in Idiopathic Thrombocytopenia (ITP): This two-armed randomized clinical trial will determine whether eradication of H Pylori in patients with ITP leads to amelioration of thrombocytopenia.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Male
Protocol Entry Criteria: No eligibility criteria
Total Enrollment:
Location and Contact Information:
Overall Study Official:
SherrillSlichter, , Puget Sound Blood Center
Additional Information:
Study ID Numbers: 144;
Study Start Date: September 2002
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00081718
Other Blood Disease Studies:
1. Delta Hepatitis and Liver Disease in Hemophiliacs
2. Induction of Stable Chimerism for Sickle Cell Anemia
3. Vietnam Era Twin (VET) Registry
4. Hepatitis Delta Infections in Hemophiliacs
5. Thalassemia (Cooley's Anemia) Clinical Research Network (TCRN)
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Transfusion Medicine/Hemostasis Clinical Research Network
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