Clinical efficacy and safety of the factor VIII/von Willebrand factor concentrate BIOSTATE in patients with von Willebrand's disease: a prospective multi-centre study.
ABSTRACT von Willebrand's disease (VWD) is an inherited bleeding disorder characterized by deficient levels of or dysfunctional von Willebrand factor (VWF). This phase II/III open-label, multicentre study evaluated the efficacy and safety of BIOSTATE, a high purity plasma-derived double-virus inactivated FVIII/VWF concentrate, when used in non-surgical bleeds, surgical procedures and prophylactic therapy in VWD patients for whom desmopressin treatment was deemed ineffective, inadequate or contraindicated. Twenty three patients (7 type 1, 9 type 2 and 7 type 3; 12 male, 11 female), who received FVIII/VWF concentrate as part of their VWD management, were recruited prospectively between December 2004 and May 2007 from eight centres in Australia and New Zealand. BIOSTATE dosing was based on pre-treatment FVIII:C and/or VWF:RCo plasma levels and a predetermined dosing guide. Haemostatic efficacy of BIOSTATE was rated as excellent or good for all major and minor surgery events, long-term prophylaxis, and for four of the six assessable non-surgical bleeding events. Blood transfusions were required by two major surgery patients as well as one patient with a non-surgical bleed. The median overall exposure to BIOSTATE across all groups was 8 days, greater in the prophylactic group (range 53-197) compared with major surgery (3-24), minor surgery (1-8) and non-surgical bleeds (1-10). BIOSTATE was shown to be efficacious and well tolerated when treating patients with VWD. This study also provides important insights into dosing regimens with BIOSTATE and the role of monitoring therapy with FVIII:C and VWF:RCo.
- Chemistry and Physics of Lipids - CHEM PHYS LIPIDS. 01/2011; 164.
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ABSTRACT: A data-aided (DA) timing recovery method for general continuous phase modulation (CPM) signaling is introduced. This method requires only symbol rate sampling and is independent of the carrier phase offset, owing to the use a differential operator. By examining the phase of the data after the differential operation, we derive an expression of the phase error caused by the timing offset and obtain an efficient timing error function. Then a feedback timing recovery algorithm is developed by exploiting this timing error function. The characteristics of the algorithm are examined through computer simulationVehicular Technology Conference, 1999 IEEE 49th; 08/1999
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ABSTRACT: Blood may be transfused as whole blood or as one of its components. Because patients seldom require all of the components of whole blood, it makes sense to transfuse only that portion needed by the patient for a specific condition or disease. This treatment, known as "blood component therapy", allows several patients to benefit from one unit of donated whole blood. Blood components include red blood cells, plasma, platelets, and cryoprecipitate. A considerable literature has accumulated over the past decade indicating that leukocytes present in allogeneic cellular blood components, intended for transfusion, are associated with adverse effects to the recipient. These include the development of febrile transfusion reactions, graft-versus-host disease, alloimmunization to leukocyte antigens, and the immunomodulatory effects that might influence the prognosis of patients with a malignancy. Moreover, it has become evident that such leukocytes may be the vector of infectious agents such as cytomegalovirus (CMV), Human T-Lymphotrophic Virus 1/11 (HTLV-I/II), and Epstein Barr (EBV) as well as other viruses. Effective stewardship of blood ensuring that several patients potentially benefit from components derived from one unit of donated whole blood is important for economic, supply/demand reasons and to protect the national inventory at times of national blood shortage. Blood safety in developing countries can be improved by more appropriate use of blood components rather than whole blood transfusion and the provision of alternatives such as oral and intravenous iron, erythropoietin, saline and colloids. This will facilitate the optimal use of the limited blood supply. Political will and open-mindedness to innovative ways to improve supply, appropriateness, optimal use and safety of blood from all types of donors are essential to promote more evidence-based approaches to blood transfusion practice in sub-Saharan Africa.Transfusion Clinique et Biologique 12/2011; 18(5-6):516-26. · 0.64 Impact Factor