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    Haemonetics Select Publications

    • 2017 Clinical trials update: Innovations in hemophilia therapy

      Hartmann, J. and Croteau, S. E.
      Am J Hematol., 2016

      A surge in therapeutic clinical trials over recent years is paving the way for transformative treatment options for patients with hemophilia. The introduction of recombinant factor concentrates in the early 1990s facilitated the use of prophylactic replacement as standard care for hemophilia rather than on-demand treatment. This has revolutionized health outcomes for hemophilia patients, enabling participation in physical activities and reducing debilitating, chronic joint damage. Challenges of prophylactic factor infusion include the frequency of infusions needed to maintain factor levels greater than 1%, patient adherence, reliable intravenous access, and development of neutralizing alloantibodies ("inhibitors"). Novel therapeutics seek to improve upon current factor concentrates by several different mechanisms: (1) extending the half-life of circulating exogenous factor protein, (2) replacing the gene necessary for production of endogenous factor protein, (3) employing bispecific antibody technology to mimic the coagulation function of factor VIII, (4) disrupting anticoagulant proteins, such as tissue factor pathway inhibitor (TFPI) or antithrombin (AT3) with antibodies, aptamers, or RNA interference technology. Emerging treatment options may reduce the frequency of (extended half-life products) or eliminate (gene therapy) the need for scheduled factor concentrate infusions, or provide a subcutaneous administration option (bispecific antibody, AT3, and TFPI targeting therapies). In addition, the nonfactor replacement strategies provide a promising treatment option for patients with inhibitors, presently the greatest unmet medical need in hemophilia. This review highlights current and recently completed clinical trials that are driving a paradigm shift in our approach to hemophilia care for patients with and without inhibitors. 

      © 2016 Wiley Periodicals, Inc.

      View abstract
    • First report of the point-of-care TEG: A technical validation study of the TEG-6S system 

      Gurbel, P.A., Bliden, K.P., Tantry, U.S., Monroe, A.L., Muresan, A.A., Brunner, N.E., Lopez-Espina, C.G., Delmenico, P.R., Cohen, E., Raviv, G., Haugen, D.L., Ereth, M.H.
      Platelets, 2016

      Thrombelastography (TEG) measured by the TEG5000 Hemostasis Analyzer is an established but the labor-intensive method for assessing global hemostasis. The first true point-of-care TEG, the TEG6s system, uses resonance-frequency viscoelasticity measurements and a disposable multi-channel microfluidic cartridge to assess hemostasis and response to antiplatelet therapy. TEG assays (n = 5,100) were performed on the blood of healthy volunteers (n = 157) and patients undergoing coronary revascularization at three hospitals (n = 300). The results from the TEG6s were compared with the conventional TEG5000 in accordance with Clinical and Laboratory Standards Institute (CLSI) and FDA recommendations. Precision testing was conducted using blood from healthy donors, all assays were run for 5 consecutive days in duplicate using multiple operators, lots, and instruments. Reference ranges were comparable between the TEG systems.

      Deming regression analysis demonstrated a strong correlation between the two systems for the standard hemostasis tests (R r = 0.932, MA r = 0.972, LY30 r = 0.938). Method comparison analysis showed an acceptable agreement between PlateletMapping (PM) assays for measuring arachidonic acid (indicator of aspirin response)- and adenosine diphosphate (indicator of P2Y12 inhibitor response)-induced platelet aggregation (total agreement = 90%, and 72%, respectively). TEG6s precision testing yielded low variability (CV 0–13%) in all measures. The new point-of-care TEG6s is associated with greater ease of use than the TEG5000 and provides precise results. The results correlated between methods for all variables. TEG6s is a promising device for near-patient hemostasis monitoring and future trials of personalized therapy designed to reduce bleeding and thrombosis. 

      View abstract
    • Transfusion reactions: Prevention, diagnosis, and treatment

      Delaney, M., Wendel, S., Bercovitz, R.S., Cid, J., Cohn, C., Dunbar, N.M., Apelseth, T.O., Popovsky, M., Stanworth, S.J., Tinmouth, A., Van De Watering, L., Waters, J.H., Yazer, M., Ziman, A.
      The Lancet, 2016

      Blood transfusion is one of the most common procedures in patients in hospital so it is imperative that clinicians are knowledgeable about appropriate blood product administration, as well as the signs, symptoms, and management of transfusion reactions. In this Review, we, an international panel, provide a synopsis of the pathophysiology, treatment, and management of each diagnostic category of transfusion reaction using evidence-based recommendations whenever available. 

      © 2016 Elsevier Ltd. All rights reserved.

      View abstract
    • Use of thromboelastography (TEG) for detection of new oral anticoagulants

      Dias, J.D., Norem, K., Doorneweerd, D.D., Thurer, R.L., Popovsky, M.A., Omert, L.A.
      Archives of Pathology and Laboratory Medicine, 2015

      Context: The clinical introduction of new oral anticoagulants (NOACs) has stimulated the development of tests to quantify the effects of these drugs and manage complications associated with their use. Until recently, the only treatment choices for the prevention of venous thromboembolism in orthopedic surgical patients, as well as for stroke and systemic embolism in patients with atrial fibrillation, were vitamin K antagonists, antiplatelet drugs, and unfractionated and low-molecular-weight heparins. With the approval of NOACs, treatment options and consequent diagnostic challenges have expanded. 

      Objective: To study the utility of thromboelastography (TEG) in monitoring and differentiating between 2 currently approved classes of NOACs, direct thrombin inhibitors (dabigatran) and factor Xa inhibitors (rivaroxaban and apixaban). 

      Design: Blood samples from healthy volunteers were spiked with each NOAC in both the presence and absence of ecarin, and the effects on TEG were evaluated. 

      Results: Both the kaolin test reaction time (R time) and the time to maximum rate of thrombus generation were prolonged versus control samples and demonstrated a dose response for apixaban (R time within the normal range) and dabigatran. The RapidTEG activated clotting time test allowed the creation of a dose-response curve for all 3 NOACs. In the presence of anti-Xa inhibitors, the ecarin test promoted significant shortening of kaolin R times to the hypercoagulable range, while in the presence of the direct thrombin inhibitor only small and dose-proportional R time shortening was observed. 

      Conclusions: The RapidTEG activated clotting time test and the kaolin test appear to be capable of detecting and monitoring NOACs. The ecarin test may be used to differentiate between Xa inhibitors and direct thrombin inhibitors. Therefore, TEG may be a valuable tool to investigate hemostasis and the effectiveness of reversal strategies for patients receiving NOACs. 

      View abstract
    • Experimental prestorage filtration removes antibodies and decreases lipids in RBC supernatants mitigating TRALI in vivo

      Silliman, C.C., Kelher, M.R., Khan, S.Y., LaSarre, M., West, F.B., Land, K.J., Mish, B., Ceriano, L., Sowemimo-Coker, S.
      Blood, 2014

      Transfusion-related acute lung injury (TRALI) remains a significant cause of transfusion-related mortality with red cell transfusion. We hypothesize that prestorage filtration may reduce proinflammatory activity in the red blood cell (RBC) supernatant and prevent TRALI. Filters were manufactured for both small volumes and RBC units. Plasma containing antibodies to human lymphocyte antigen (HLA)-A2 or human neutrophil antigen (HNA)-3a was filtered, and immunoglobulins and specific HNA-3a and HLA-2a neutrophil (PMN) priming activity were measured. Antibodies to OX27 were added to plasma, and filtration was evaluated in a 2-event animal model of TRALI. RBC units from 31 donors known to have antibodies against HLA antigens and from 16 antibody-negative controls were filtered. Furthermore, 4 RBC units were drawn and underwent standard leukoreduction. Immunoglobulins, HLA antibodies, PMN priming activity, and the ability to induce TRALI in an animal model were measured. Small-volume filtration of plasma removed >96% of IgG, antibodies to HLA-A2 and HNA-3a, and their respective priming activity, as well as mitigating antibody-mediated in vivo TRALI. In RBC units, experimental filtration removed antibodies to HLA antigens and inhibited the accumulation of lipid priming activity and lipid-mediated TRALI. We conclude that filtration removes proinflammatory activity and the ability to induce TRALI from RBCs and may represent a TRALI mitigation step. 

      © 2014 by The American Society of Hematology.

      View abstract
    • Washing older blood units before transfusion reduces plasma iron and improves outcomes in experimental canine pneumonia

      Corteś-Puch, I., Wang, D., Sun, J., Solomon, S.B., Remy, K.E., Fernandez, M., Feng, J., Kanias, T., Bellavia, L., Sinchar, D., Perlegas, A., Solomon, M.A., Kelley, W.E., Popovsky, M.A., Gladwin, M.T., Kim-Shapiro, D.B., Klein, H.G., Natanson, C.
      Blood, 2014

      In a randomized controlled blinded trial, 2-year-old purpose-bred beagles (n = 24), with Staphylococcus aureus pneumonia, were exchanged-transfused with either 7- or 42-day-old washed or unwashed canine universal donor blood (80 mL/kg in 4 divided doses). Washing red cells (RBC) before transfusion had a significantly different effect on canine survival, multiple organ injury, plasma iron, and cell-free hemoglobin (CFH) levels depending on the age of stored blood (all, P < .05 for interactions). Washing older units of blood improved survival rates, shock score, lung injury, cardiac performance and liver function, and reduced levels of non-transferrin bound iron and plasma labile iron. In contrast, washing fresh blood worsened all these same clinical parameters and increased CFH levels. Our data indicate that transfusion of fresh blood, which results in less hemolysis, CFH, and iron release, is less toxic than transfusion of older blood in critically ill infected subjects. However, washing older blood prevented elevations in plasma circulating iron and improved survival and multiple organ injury in animals with an established pulmonary infection. Our data suggest that fresh blood should not be washed routinely because, in a setting of established infection, washed RBC are prone to release CFH and result in worsened clinical outcomes.

      View abstract
    • Evaluation of an experimental filter designed for improving the quality of red blood cells (RBCs) during storage by simultaneously removing white blood cells and immunomodulators and improving RBC viscoelasticity and Band 3 proteins

      Sowemimo-Coker, S.O.
      Transfusion, 2014

      Background: Storage age of red blood cells (RBCs) has been reported to be associated with increased mortality and morbidity. During storage, RBCs undergo changes in biochemical and functional properties. Stored RBCs may also contain white blood cells (WBCs), activated platelets (PLTs), cytokines, immunoglobulin, and other bioactive proteins. Transfusion of these bioactive proteins and cells with RBCs has the potential to cause serious adverse effects. We evaluated the performances of an experimental filter (EF) designed to remove immunoglobulins, cytokines, and other bioactive proteins in RBCs.

      Study Design and Methods: Sixteen sets, each containing 3 units of ABO-identical RBCs in AS-3 were obtained from a blood bank. Three units of RBCs were combined together and then split into three equal aliquots, A, B, and C. Unit A was unfiltered while Units B and C were filtered with a leukoreduction filter and the EF, respectively. All the units were stored at 4°C in a blood bank refrigerator for 42 days. We measured RBC viscoelasticity, hemolysis, RBC adenosine triphosphate, Band 3 proteins, cytokines, PLTs, WBCs, and immunoglobulin before and after filtration and on Days 21 and 42 of storage. Data were analyzed by repeated-measures analysis of variance with Newman-Keuls multiple comparison test.

      Results: The EF significantly (p<0.05) reduced the levels of immunoglobulin (control IgG, 2.184 ± 1.918 mg/mL; BPF4, 2.216 ± 1.956 mg/mL; and EF, 0.363 ± 0.391 mg/mL), PLTs, cytokines, and improved viscoelastic properties when compared to either control or leukoreduced RBCs.

      Conclusion: The EF achieved lower levels of WBCs, improved viscoelastic properties, and reduced levels of immunoglobulins and cytokines but significance will require clinical evaluation. 

      © 2013 American Association of Blood Banks.

      View abstract
    • How we view and approach transfusion-associated circulatory overload: Pathogenesis, diagnosis, management, mitigation, and prevention

      Andrzejewski Jr., C., Casey, M.A., Popovsky, M.A.
      Transfusion, 2013

      Although recognized as a serious complication of hemotherapy, few data are available on the incidence of transfusion-associated circulatory overload (TACO). Detailed demographic and clinical information was obtained from records of 382 Medicare patients undergoing total hip or knee replacements (and receiving transfusions) from January 1992 to December 1993 at five Massachusetts hospitals. Seventy-eight percent of the patients were women with a mean age of 77 years. Thirty-two percent had co-morbidities including myocardial or coronary disease. Transfusion-related complications and comorbidities were identified and reviewed by transfusion experts. Patients were excluded from consideration if non-transfusion factors such as myocardial disease could have contributed to the development of acute pulmonary edema. Four (3 females, 1 male) patients (1.05%) developed TACO postoperatively. Mean age of these patients was 84 years (range, 75-101) versus 77 years for non-TACO. The mean intraoperative estimated blood loss was 375 mL. Each patient received only 1-2 units of red blood cells prior to onset of TACO, and in two cases only autologous blood was used. The mean positive fluid balance was 2,480 mL. The mean pretransfusion hematocrit prior to circulatory overload (CO) was 26.0 percent. Symptoms were reversed with diuretics. Length of stay was significantly prolonged by these incidents. TACO is a frequent and serious event in an orthopedic surgical setting. It is associated with advanced age, increased health care costs, and may occur in the setting of modest transfusion volumes. The utilization of conservative transfusion criteria and fluid management in the perioperative setting may decrease the incidence of this complication in this population.

      View abstract
    • Anemia, iron depletion, and the blood donor: It's time to work on the donor's behalf

      Popovsky, M.A.
      Transfusion, 2012

      Objective: The study objective was to determine the effects of implementing a blood conservation algorithm on blood product use and outcomes in a community cardiac surgery program.

      Methods: A blood management strategy including lower hemoglobin transfusion threshold and algorithm-driven decisions was adopted. Intraoperatively, point-of-care testing was used to avoid inappropriate component transfusion. A low prime perfusion circuit was adopted. Blood was withdrawn from patients before initiating bypass when possible. Patients undergoing coronary and valve procedures were included. Outlier patients receiving more than 10 units packed red blood cells were excluded. Data were collected for 6 months as a baseline group (group I). A 3-month period of program implementation was allotted. Data were subsequently collected for 6 months and comprised the study patients (group II). Prospective data were collected on demographics, blood use, and outcomes.

      Results: Group I comprised 481 patients, and group II comprised 551 patients. Group II received fewer units of packed red blood cells, fresh-frozen plasma, and cryoprecipitate than group I. There was no difference in platelets transfused. Total blood product use was reduced by 40% in group II (P < .001). The overall 30-day mortality was 1.3%. There were no differences in mortality, reoperation for bleeding, or other postoperative outcomes between the groups.

      Conclusions: Implementation of a comprehensive blood conservation algorithm can be rapidly introduced, leading to reductions in blood and component use with no detrimental effect on early outcomes. Point-of-care testing can direct component transfusion in coagulopathic cases, with most coagulopathic patients requiring platelets. Further research will determine the effects of reduced transfusions on long-term outcomes. 

      © 2012 The American Association for Thoracic Surgery. Published by Mosby, Inc. All rights reserved.

      View abstract
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