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Effective inactivation of a wide range of viruses by pasteurization.
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Effective inactivation of a wide range of viruses by pasteurization.

Transfusion. 2017 Nov 16;:

Authors: Gröner A, Broumis C, Fang R, Nowak T, Popp B, Schäfer W, Roth NJ

Abstract
BACKGROUND: Careful selection and testing of plasma reduces the risk of blood-borne viruses in the starting material for plasma-derived products. Furthermore, effective measures such as pasteurization at 60°C for 10 hours have been implemented in the manufacturing process of therapeutic plasma proteins such as human albumin, coagulation factors, immunoglobulins, and enzyme inhibitors to inactivate blood-borne viruses of concern. A comprehensive compilation of the virus reduction capacity of pasteurization is presented including the effect of stabilizers used to protect the therapeutic protein from modifications during heat treatment.
STUDY DESIGN AND METHODS: The virus inactivation kinetics of pasteurization for a broad range of viruses were evaluated in the relevant intermediates from more than 15 different plasma manufacturing processes. Studies were carried out under the routine manufacturing target variables, such as temperature and product-specific stabilizer composition. Additional studies were also performed under robustness conditions, that is, outside production specifications.
RESULTS: The data demonstrate that pasteurization inactivates a wide range of enveloped and nonenveloped viruses of diverse physicochemical characteristics. After a maximum of 6 hours' incubation, no residual infectivity could be detected for the majority of enveloped viruses. Effective inactivation of a range of nonenveloped viruses, with the exception of nonhuman parvoviruses, was documented.
CONCLUSION: Pasteurization is a very robust and reliable virus inactivation method with a broad effectiveness against known blood-borne pathogens and emerging or potentially emerging viruses. Pasteurization has proven itself to be a highly effective step, in combination with other complementary safety measures, toward assuring the virus safety of final product.

PMID: 29148053 [PubMed - as supplied by publisher]




Factors affecting patient-reported outcomes after red blood cell transfusion in medical patients.
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Factors affecting patient-reported outcomes after red blood cell transfusion in medical patients.

Transfusion. 2017 Nov 13;:

Authors: Chan KLL, Mak WMV, Tam YH, Lee KKH

Abstract
BACKGROUND: Physical variables like mortality or cardiac events were used to evaluate the requirement of red blood cell (RBC) transfusion. However, patient-reported outcomes (PROs) of blood transfusion recipients were seldom assessed. The health-related quality of life (HRQoL) of patients before and after RBC transfusion was compared in this study.
STUDY DESIGN AND METHODS: The study period was February to June 2016. Standardized generic and anemia symptom-specific HRQoL instruments were administered to patients receiving RBC transfusion in the medical unit of a single center. The primary outcome was the change in HRQoL scores on Days 1 and 7 posttransfusion from baseline values on the day of transfusion (Day 0). Multiple linear regression analysis was performed to study the effect of transfusion strategy and other factors on PRO.
RESULTS: The analysis included 99 general medical patients. The median (interquartile range) pretransfusion hemoglobin level was 72 (66-78) g/L. Two or more units of RBCs were prescribed to 45 patients (45%) on Day 0. Functional Assessment of Cancer Therapy-Anemia Subscale improved significantly on Days 1 and 7 by effect sizes of 0.41 and 0.38, respectively (p < 0.001). Regression analysis showed that lower baseline HRQoL scores were associated with better PRO on both Day 1 and Day 7 (p < 0.001). Transfusion trigger and number of RBC units transfused did not affect the change in HRQoL.
CONCLUSION: Worse pretransfusion HRQoL is a predictor of improvement in PRO after blood transfusion. There is no evidence that a restrictive transfusion or single-unit policy jeopardizes PRO.

PMID: 29134668 [PubMed - as supplied by publisher]




Dose capping of plerixafor in patients weighing more than 100 kg at one vial led to successful mobilization outcomes and significant cost savings.
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Dose capping of plerixafor in patients weighing more than 100 kg at one vial led to successful mobilization outcomes and significant cost savings.

Transfusion. 2017 Nov 13;:

Authors: Park G, Shayani S, Stiller T, Wang S, Yuan S

Abstract
BACKGROUND: Plerixafor is frequently used as an adjunct agent to improve mobilization of peripheral blood stem cells in many clinical settings. However, its high cost (>$8000 per single-use 24-mg vial) is a significant concern. The manufacturer-recommended dose is 0.24 mg/kg. Therefore, patients weighing more than 100 kg would require a second vial, thus doubling the drug cost per dose. We implemented a policy of capping the dose of plerixafor at 24 mg, or one vial, for patients weighing more than 100 kg. This retrospective study compares the mobilization of patients more than 100 kg who received capped doses, with historical control patients who received full, uncapped doses.
STUDY DESIGN AND METHODS: Consecutive, eligible patients weighing more than 100 kg who received capped (n = 47) and full doses of plerixafor (n = 40) were identified. Plerixafor was given up-front, as a rescue agent due to suboptimal mobilization, or during remobilization. Baseline characteristics and mobilization data were collected and compared.
RESULTS: Patients in the two groups showed comparable baseline characteristics. They collected similar total numbers of CD34+ cells/kg (median, 4.08 × 10(6) vs. 3.36 × 10(6) CD34+ cells/kg; p = 0.86) and achieved comparable collection success rates as defined by collecting more than 2.0 × 10(6) CD34+ cells/kg (98% vs. 90%, p = 0.21). However, patients who received capped doses required only half of the number of vials of plerixafor (median, 3 vials vs. 6 vials; p < 0.0001).
CONCLUSION: Dose capping plerixafor at 24 mg for patients more than 100 kg is a cost-effective strategy, which achieved comparable mobilization outcomes and reduced the total number of vials of plerixafor used by half.

PMID: 29134662 [PubMed - as supplied by publisher]




"Best practice" for extracorporeal photopheresis in acute and chronic graft-versus-host disease by Societa' Italiana di Emaferesi and Manipolazione Cellulare and Gruppo Italiano Trapianto Midollo Osseo: a national survey to ascertain its degree of application in Italian transplant centers.
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"Best practice" for extracorporeal photopheresis in acute and chronic graft-versus-host disease by Societa' Italiana di Emaferesi and Manipolazione Cellulare and Gruppo Italiano Trapianto Midollo Osseo: a national survey to ascertain its degree of application in Italian transplant centers.

Transfusion. 2017 Nov 13;:

Authors: Pierelli L, Bosi A, Olivieri A

Abstract
BACKGROUND: A recent "best practice" promoted and published by Gruppo Italiano Trapianto Midollo Osseo (GITMO) and Societa' Italiana di Emaferesi and Manipolazione Cellulare (SIDEM) on the use of extracorporeal photopheresis (ECP) in acute and chronic graft-versus-host disease (GVHD) has been tested for the degree of agreement and application among Italian transplant centers.
STUDY DESIGN AND METHODS: Twenty-four Italian centers coordinating a pair number of transplant programs completed the Web-based survey within the fixed deadline, representing approximately 52% of those centers that have a GITMO-accredited allogeneic transplant program that routinely uses ECP in GVHD.
RESULTS: The level of full agreement was more than 85% for most of the answers given by the best practice (14 of 16) to the various issues. For the answers of two questions dealing with indications of ECP in acute GVHD and with safety and quality measures we observed a full agreement of 62 and 50%, respectively.
CONCLUSION: This report shows a very good success of best practice among Italian centers, indicating that, after 3 years, it seems to be still updated and useful. More discussion has been observed for safety and quality measures and, likely, this issue deserves a dedicated focus on a future consensus report.

PMID: 29134658 [PubMed - as supplied by publisher]