Clinical disorders that affect hemostasis and require replacement transfusions are common and life threatening disorders. Progress in developing better methods of defining new and more effective treatments for these disorders is complicated by the lack of mechanisms for coordinated studies. This application is in response to an RFA to participate in a Transfusion Medicine/Hemostasis Clinical Research Network. The resources available at the University of North Carolina at Chapel Hill for participation in a such a network are described, including the institutional commitment and excellence in the areas of hemostasis and transfusion medicine and the strong institutional emphasis on clinical research and the resources supporting clinical research. These resources provide well-defined study populations and access to large numbers of patients. Two clinical trials are proposed for the network. The first is a short term, multicenter study to use automated culture to monitor bacterial contamination of platelet concentrates under normal storage conditions.
The aim of the study is to extend the shelf life of platelets. Platelet concentrates will be cultured on day 2 and the results of the culture used to extend the shelf life of sterile platelets from 5 to 7 days. The second study is a long term, multicenter, double-masked, placebo-controlled trial of recombinant VIla in patients with severe trauma and uncontrolled bleeding.
The aim of the study is to determine the efficacy of recombinant factor Vlla as a hemostatic agent in severe trauma with bleeding that is refractory to standard replacement with fresh frozen plasma. The primary endpoint in the study is survival, determined at 24 h, 48 h, and 28 days. The secondary endpoints are the number of blood products infused, the number of days on ventilatory assistance, the number of days in the intensive care unit, the number of hospital days, and the extent of organ dysfunction.

Agency
National Institute of Health (NIH)
Institute
National Heart, Lung, and Blood Institute (NHLBI)
Type
Research Project--Cooperative Agreements (U01)
Project #
1U01HL072355-01
Application #
6571564
Study Section
Special Emphasis Panel (ZHL1-CSR-R (S1))
Program Officer
Harvath, Liana
Project Start
2002-09-30
Project End
2007-08-31
Budget Start
2002-09-30
Budget End
2003-08-31
Support Year
1
Fiscal Year
2002
Total Cost
$300,000
Indirect Cost
Name
University of North Carolina Chapel Hill
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
078861598
City
Chapel Hill
State
NC
Country
United States
Zip Code
27599
Uhl, Lynne; Assmann, Susan F; Hamza, Taye H et al. (2017) Laboratory predictors of bleeding and the effect of platelet and RBC transfusions on bleeding outcomes in the PLADO trial. Blood 130:1247-1258
Leissinger, C; Josephson, C D; Granger, S et al. (2014) Rituximab for treatment of inhibitors in haemophilia A. A Phase II study. Thromb Haemost 112:445-58
Josephson, Cassandra D; Granger, Suzanne; Assmann, Susan F et al. (2012) Bleeding risks are higher in children versus adults given prophylactic platelet transfusions for treatment-induced hypoproliferative thrombocytopenia. Blood 120:748-60
Triulzi, Darrell J; Assmann, Susan F; Strauss, Ronald G et al. (2012) The impact of platelet transfusion characteristics on posttransfusion platelet increments and clinical bleeding in patients with hypoproliferative thrombocytopenia. Blood 119:5553-62
Slichter, Sherrill J; Kaufman, Richard M; Assmann, Susan F et al. (2010) Dose of prophylactic platelet transfusions and prevention of hemorrhage. N Engl J Med 362:600-13
Steiner, M E; Assmann, S F; Levy, J H et al. (2010) Addressing the question of the effect of RBC storage on clinical outcomes: the Red Cell Storage Duration Study (RECESS) (Section 7). Transfus Apher Sci 43:107-16
Afenyi-Annan, Araba; Brecher, Mark E; Bandarenko, Nicholas (2007) Update on multi-center clinical trials in the United States. Transfus Apher Sci 36:5-12
Slichter, Sherrill J (2006) Background, rationale, and design of a clinical trial to assess the effects of platelet dose on bleeding risk in thrombocytopenic patients. J Clin Apher 21:78-84