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A mathematical model for estimating residual transmission risk of occult hepatitis B virus infection with different blood safety scenarios.
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A mathematical model for estimating residual transmission risk of occult hepatitis B virus infection with different blood safety scenarios.

Transfusion. 2017 Feb 28;:

Authors: Weusten J, van Drimmelen H, Vermeulen M, Lelie N

Abstract
BACKGROUND: If anti-hepatitis B core antibody testing is not mandated blood donors with occult hepatitis B infection (OBI) may transmit hepatitis B virus (HBV) to a recipient in spite of the use of nucleic acid amplification technology (NAT) or pathogen inactivation (PI).
STUDY DESIGN AND METHODS: We developed a model to estimate OBI transmission risk based on three components: the probability distribution of the viral load (VL) in a randomly selected OBI donor, the probability that a given VL remains undetected, and the probability that this VL causes infection in the recipient. A subset of 217 South African OBI samples identified by individual donation (ID)-NAT screening were quantified by replicate testing using an ID-NAT assay (Ultrio Plus) against HBV DNA standard dilution series. The observed log VLs could be described by a Gumbel distribution. A correction was included to compensate for OBI samples missed by initial ID-NAT screening.
RESULTS: The model estimates that 3.3% of all OBI donations are undetected by ID-NAT (Ultrio Plus) and cause infection by a blood component containing 20 mL plasma, going up to 8.7% when using minipools of 6 (MP6)-NAT. For 200-mL plasma transfusion these risks were estimated at 14 and 28%, respectively, while PI with modest (2 log) reduction capacity would reach 4.8% without NAT and 1.3 or 0.4% when combined with MP6- or ID-NAT.
CONCLUSION: The model can be used to compare different screening and/or PI strategies in reducing viral transmission risk and could serve as a tool in evaluating efficacy of alternative blood safety scenarios.

PMID: 28244600 [PubMed - as supplied by publisher]




Clinical effectiveness of platelets in additive solution treated with two commercial pathogen-reduction technologies.
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Clinical effectiveness of platelets in additive solution treated with two commercial pathogen-reduction technologies.

Transfusion. 2017 Feb 24;:

Authors: Rebulla P, Vaglio S, Beccaria F, Bonfichi M, Carella A, Chiurazzi F, Coluzzi S, Cortelezzi A, Gandini G, Girelli G, Graf M, Isernia P, Marano G, Marconi M, Montemezzi R, Olivero B, Rinaldi M, Salvaneschi L, Scarpato N, Strada P, Milani S, Grazzini G

Abstract
BACKGROUND: Two noninferiority, randomized, controlled trials were conducted in parallel comparing the safety and efficacy of platelets treated with Intercept or Mirasol pathogen-reduction technologies versus standard platelets.
STUDY DESIGN AND METHODS: The primary endpoint was the percentage of hematology patients who developed World Health Organization Grade 2 or greater bleeding. A noninferiority margin of 11% was chosen based on expected Grade 2 or greater bleeding in 20% of controls. The study was closed for financial restrictions before reaching the planned sample size of 828 patients, and an intention-to-treat analysis was conducted on 424 evaluable patients.
RESULTS: In the Intercept trial (113 treated vs. 115 control patients), the absolute risk difference in Grade 2 or greater bleeding was 6.1%, with an upper one-sided 97.5% confidence limit of 19.2%. The absolute risk difference in the Mirasol trial (99 treated vs. 97 control patients) was 4.1%, and the upper one-sided 97.5% confidence limit was 18.4%. Neither absolute risk difference was statistically significant. In both trials, posttransfusion platelet count increments were significantly lower in treated versus control patients. Mean blood component use in treated patients versus controls was 54% higher (95% confidence interval, 36%-74%; Intercept) and 34% higher (95% confidence interval, 16%-54%; Mirasol) for platelets and 23% higher (95% confidence interval, 8%-39%; Intercept) and 32% higher (95% confidence interval, 10%-57%; Mirasol) for red blood cells. Unexpected reactions and adverse events were not reported. Mortality did not differ significantly between treated and control patients.
CONCLUSION: Although conclusions on noninferiority could not be drawn due to low statistical power, the study provides additional information on the safety and efficacy of pathogen-reduced platelets treated with two commercial pathogen-reduction technologies.

PMID: 28236335 [PubMed - as supplied by publisher]




Human platelet antigen (HPA)-specific immunoglobulin M antibodies in neonatal alloimmune thrombocytopenia can inhibit the binding of HPA-specific immunoglobulin G antibodies.
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Human platelet antigen (HPA)-specific immunoglobulin M antibodies in neonatal alloimmune thrombocytopenia can inhibit the binding of HPA-specific immunoglobulin G antibodies.

Transfusion. 2017 Feb 24;:

Authors: Hopkins M, Lucas G, Calvert A, Bendukidze N, Green F, Kotecha K, Poles A

Abstract
BACKGROUND: A term baby with unexplained thrombocytopenia and a platelet (PLT) count of 14 × 10(9) /L (maternal PLT count was 200 × 10(9) /L) was investigated for neonatal alloimmune thrombocytopenia.
STUDY DESIGN AND METHODS: Serologic investigations were performed using the PLT immunofluorescence test (PIFT), monoclonal antibody immobilization of PLT antigens (MAIPA), and a bead-based assay (BBA) with maternal sera taken up to 56 days postdelivery. One serum sample was also separated into "immunoglobulin (Ig)M-rich" and "IgM-depleted" fractions and tested for PLT-specific antibodies. The family was genotyped for HPA.
RESULTS: HPA-3a-specific IgM antibodies were detected in the PIFT and confirmed in the BBA. PLT-specific IgG HPA-3a antibodies were not detected in the MAIPA assay and BBA in the initial sample but were detected in both techniques in subsequent serum samples. Testing of IgM-rich and IgM-depleted fractions in the MAIPA assay revealed that IgG antibody binding of the IgM-depleted fraction was inhibited by approximately 50% when it was reconstituted with the IgM-rich fraction suggesting that the IgM antibodies blocked the binding of the IgG antibodies. This effect was not observed when the IgM-depleted fraction or untreated serum was diluted with elution buffer. Incompatibility for HPA-3 was identified between the mother and the infant. The infant received one HPA-1a, -5b negative neonatal PLT transfusion, and one random PLT transfusion, with satisfactory outcomes. Both units were later found to be HPA-3b3b.
CONCLUSION: HPA-3a IgM antibodies can inhibit PLT-specific HPA-3a IgG antibodies in the MAIPA assay.

PMID: 28236317 [PubMed - as supplied by publisher]




An international survey on the role of the hospital transfusion committee.
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An international survey on the role of the hospital transfusion committee.

Transfusion. 2017 Feb 24;:

Authors: Yazer MH, Lozano M, Fung M, Kutner J, Murphy MF, Oveland Apelseth T, Pogłód R, Selleng K, Tinmouth A, Wendel S, Yahalom V, Biomedical Excellence for Safer Transfusion (BEST) Collaborative

Abstract
BACKGROUND: Hospital transfusion committees (HTCs) can oversee all aspects of transfusion practice at a hospital. This survey sought to identify which quality variables were being reported at HTCs around the world.
STUDY DESIGN AND METHODS: A working party composed of members of the Biomedical Excellence for Safer Transfusion (BEST) collaborative developed a survey of quality variables that could be potentially presented at HTC meetings. The survey was electronically sent to all BEST members who were encouraged to complete it if they were active on an HTC and to send it to other colleagues with similar experience. An expert panel was convened to determine which quality variables are the most important for review at HTC meetings.
RESULTS: There were 121 respondents; the majority were from Europe (52%), Asia (19%), or North America (19%). Most respondents (68%) were at university hospitals. Of the 117 (97%) respondents with an HTC, the committee most often met quarterly (42%) and reviewed transfusion reactions (79%) and risk management-reported events (52%). The HTCs most commonly included transfusion medicine physicians, anesthesiologists, and other physicians who regularly transfuse blood products. Some of the most commonly reported quality variables included number of blood products transfused, wasted, and expired and the number of improperly labeled specimens. The expert panel analysis revealed that some variables that were deemed important were not being frequently reported at HTCs.
CONCLUSION: There is variability in the variables being reported at HTCs around the world with some important variables not frequently reported.

PMID: 28236313 [PubMed - as supplied by publisher]




p38 mitogen-activated protein kinase regulates mitochondrial function and microvesicle release in riboflavin- and ultraviolet light-treated apheresis platelet concentrates.
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p38 mitogen-activated protein kinase regulates mitochondrial function and microvesicle release in riboflavin- and ultraviolet light-treated apheresis platelet concentrates.

Transfusion. 2017 Feb 24;:

Authors: Chen Z, Schubert P, Bakkour S, Culibrk B, Busch MP, Devine DV

Abstract
BACKGROUND: Biochemical analyses of mechanisms triggered in platelets (PLTs) upon pathogen inactivation (PI) are crucial to further understand the impact of PI on PLT functionality and, subsequently, quality.
STUDY DESIGN AND METHODS: PLT concentrates (PCs) were split into four small illumination bags: 1) untreated control, 2) treated with riboflavin and ultraviolet light (RF/UV), and spiked with 3) solvent control dimethyl sulfoxide and 4) p38 mitogen-activated protein kinase (MAPK) inhibitor SB203580 before RF/UV treatment. Flow cytometry was used to monitor PLT mitochondrial potential (ΔΨm ); generation of intracellular reactive oxygen species (ROS); and release of microvesicles (MVs), mitochondria (MT), and MVs containing MT (MVs/MT). Quantitative polymerase chain reaction (qPCR) was used to quantify extracellular mitochondrial DNA (mtDNA). Translocation of selected mitochondrial proteins was analyzed in subcellular fractions by immunoblot.
RESULTS: RF/UV treatment triggered an increased mitochondrial translocation of both Bax and Bid (p < 0.05, Day 7) and cytochrome c release (p < 0.01, Day 7), loss of ΔΨm (p < 0.05, Day 5 and Day 7), and ROS generation (p < 0.01, Day 5 and Day 7) in PCs compared to the untreated control during storage. These PI-triggered changes were inhibited by SB203580 (p < 0.05). The release of MVs, MT, and MVs/MT was increased upon the RF/UV treatment during storage (p < 0.05) and, with the exception of MT, the release was decreased by the inhibitor (p < 0.05). qPCR analysis showed that RF/UV does not trigger mtDNA release during storage.
CONCLUSION: These findings further our understanding of mechanisms in PLTs initiated by the RF/UV treatment, demonstrating that this treatment induces p38 MAPK-dependent mitochondrial signaling and MV release in apheresis PCs.

PMID: 28236306 [PubMed - as supplied by publisher]




Autologous lymphapheresis for the production of chimeric antigen receptor T cells.
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Autologous lymphapheresis for the production of chimeric antigen receptor T cells.

Transfusion. 2017 Feb 24;:

Authors: Allen ES, Stroncek DF, Ren J, Eder AF, West KA, Fry TJ, Lee DW, Mackall CL, Conry-Cantilena C

Abstract
BACKGROUND: The first step in manufacturing chimeric antigen receptor (CAR) T cells is to collect autologous CD3+ lymphocytes by apheresis. Patients, however, often have leukopenia or have other disease-related complications. We evaluated the feasibility of collecting adequate numbers of CD3+ cells, risk factors for inadequate collections, and the rate of adverse events.
STUDY DESIGN AND METHODS: Apheresis lymphocyte collections from patients participating in three CAR T-cell clinical trials were reviewed. Collections were performed on the COBE Spectra by experienced nurses, with the goal of obtaining a minimum of 0.6 × 10(9) and a target of 2 × 10(9) CD3+ cells. Preapheresis peripheral blood counts, apheresis parameters, and product cell counts were analyzed.
RESULTS: Of the 71 collections, 69 (97%) achieved the minimum and 55 (77%) achieved the target. Before apheresis, the 16 patients with yields below the target had significantly lower proportions and absolute numbers of circulating lymphocytes and CD3+ lymphocytes and higher proportions of circulating blasts and NK cells than those who achieved the target (470 × 10(6) lymphocytes/L vs. 1340 × 10(6) lymphocytes/L, p = 0.008; 349 × 10(6) CD3+ cells/L vs. 914 × 10(6) CD3+ cells/L, p = 0.001; 17.6% blasts vs. 4.55% blasts, p = 0.029). Enrichment of blasts in the product compared to the peripheral blood occurred in four patients, including the two patients whose collections did not yield the minimum number of CD3+ cells. Apheresis complications occurred in 11 patients (15%) and, with one exception, were easily managed in the apheresis clinic.
CONCLUSIONS: In most patients undergoing CAR T-cell therapy, leukapheresis is well tolerated, and adequate numbers of CD3+ lymphocytes are collected.

PMID: 28236305 [PubMed - as supplied by publisher]




Characterization of hepatitis B virus (HBV) preS/S gene mutations in blood donors with occult HBV infection in the Baoji area of North China.
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Characterization of hepatitis B virus (HBV) preS/S gene mutations in blood donors with occult HBV infection in the Baoji area of North China.

Transfusion. 2017 Feb 24;:

Authors: Liao H, Liu Y, Chen J, Ding W, Li X, Xu Z, Yang Y, Chen R, Si L, Xu X, Guo J, Xu D

Abstract
BACKGROUND: Occult hepatitis B virus (HBV) infection (OBI) in blood donors was investigated in the Baoji area of North China, and OBI-related viral mutations in donors were characterized.
STUDY DESIGN AND METHODS: In total, 110,843 blood donor samples that were consecutively collected from December 2011 to March 2015 at the Baoji Blood Center were examined. Hepatitis B surface antigen-negative and HBV DNA-positive OBI samples were amplified for sequence analysis of OBI-related mutations in the HBV preS/S region. HBV genomes from 108 adult patients with chronic hepatitis B from North China were used as controls.
RESULTS: OBI was detected in 60 (1:1847) individual blood donors. All OBI samples were negative for hepatitis B e-antigen, and 55 were positive for anti-hepatitis B core antigen. The preS/S genes were successfully sequenced for 43 OBI samples. OBI-related S gene mutations in the major hydrophilic region were detected more frequently in blood donors with OBI than that in controls (51.16 vs. 12.96%; p < 0.01). Specifically, the incidence of five OBI-related major hydrophilic region mutations (sS117T, sT118K, sT131N, sT134Y/L, and sD144E) was significantly higher in blood donors with OBI than in controls. In addition, the coexistence of multiple OBI-related mutations in the major hydrophilic region was detected more frequently in donors than in controls (30.23 vs. 1.85%; p < 0.01), and preS deletions greater than 33 base pairs also were detected more frequently in blood donors with OBI than in controls.
CONCLUSION: OBI in blood donors should be addressed attentively in the Baoji area of North China, and HBV preS/S gene mutations may play an important role in OBI prevalence in the area.

PMID: 28236303 [PubMed - as supplied by publisher]




Pathogen inactivation treatment of plasma and platelet concentrates and their predicted functionality in massive transfusion protocols.
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Pathogen inactivation treatment of plasma and platelet concentrates and their predicted functionality in massive transfusion protocols.

Transfusion. 2017 Feb 24;:

Authors: Arbaeen AF, Schubert P, Serrano K, Carter CJ, Culibrk B, Devine DV

Abstract
BACKGROUND: Trauma transfusion packages for hemorrhage control consist of red blood cells, plasma, and platelets at a set ratio. Although pathogen reduction improves the transfusion safety of platelet and plasma units, there is an associated reduction in quality. This study aimed to investigate the impact of riboflavin/ultraviolet light-treated plasma or platelets in transfusion trauma packages composed of red blood cell, plasma, and platelet units in a ratio of 1:1:1 in vitro by modeling transfusion scenarios for trauma patients and assessing function by rotational thromboelastometry.
STUDY DESIGN AND METHODS: Pathogen-reduced or untreated plasma and buffy coat platelet concentrate units produced in plasma were used in different combinations with red blood cells in trauma transfusion packages. After reconstitution of these packages with hemodiluted blood, the hemostatic functionality was analyzed by rotational thromboelastometry.
RESULTS: Hemostatic profiles of pathogen-inactivated buffy coat platelet concentrate and plasma indicated decreased activity compared with their respective controls. Reconstitution of hemodiluted blood (hematocrit = 20%) with packages that contained treated or nontreated components resulted in increased alpha and maximum clot firmness and enhanced clot-formation time. Simulating transfusion scenarios based on 30% blood replacement with a transfusion trauma package resulted in a nonsignificant difference in rotational thromboelastometry parameters between packages containing treated and nontreated blood components (p ≥ 0.05). Effects of pathogen inactivation treatment were evident when the trauma package percentage was 50% or greater and contained both pathogen inactivation-treated plasma and buffy coat platelet concentrate.
CONCLUSION: Rotational thromboelastometry investigations suggest that there is relatively little impact of pathogen inactivation treatment on whole blood clot formation unless large amounts of treated components are used.

PMID: 28236302 [PubMed - as supplied by publisher]




Development of the Platelet Efficacy Score (PEscore) to predict the efficacy of platelet transfusion in oncohematologic patients.
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Development of the Platelet Efficacy Score (PEscore) to predict the efficacy of platelet transfusion in oncohematologic patients.

Transfusion. 2017 Feb 24;:

Authors: Quaglietta A, Di Saverio M, Lucisano G, Accorsi P, Nicolucci A

Abstract
BACKGROUND: Despite the prophylactic use of platelet transfusion, hemorrhagic complications still represent an important cause of morbidity and mortality in patients with hematologic malignancies. Patient-related factors and characteristics of the transfused product can affect transfusion efficacy.
STUDY DESIGN AND METHODS: The aim of this study was to develop and validate the Platelet Efficacy Score (PEscore), based on patient and product characteristics, to predict the likelihood of a satisfactory platelet transfusion (absolute increment ≥10.5 × 10(9) /L). This study utilized data relative to 16,265 platelet transfusions performed in 1592 oncohematologic patients. The whole sample was divided into two random samples: a training set, in which different patient-related and transfusion-related characteristics were included in a predictive model to develop the PEscore; and a validation set, in which the predictive properties of the PEscore were confirmed. In the training set, multilevel logistic regression analysis was performed in which the likelihood of attaining a satisfactory transfusion was modeled.
RESULTS: The predictive score ranged between 0 and 30. Predictive properties of the PEscore were confirmed by the observed rates of satisfactory transfusions in the validation sample; the probability of a satisfactory transfusion was less than 10% for a score less than 12 and exceeded 50% if the score was 22 or higher. The likelihood of a satisfactory transfusion increased by 29% for a 1-unit increase in the PEscore (odds ratio, 1.29; 95% confidence interval, 1.27-1.31).
CONCLUSION: The availability of a prediction score can increase transfusion efficacy, help the transfusion medicine specialist in the choice of the best product for the individual patient, and avoid waste of resources.

PMID: 28236299 [PubMed - as supplied by publisher]




Molecular characterization of three novel weak D type alleles with additional haplotype data on weak D Types 1.2 and 18.
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Molecular characterization of three novel weak D type alleles with additional haplotype data on weak D Types 1.2 and 18.

Transfusion. 2017 Feb 24;:

Authors: Anani WQ, Yassai MB, Bensing KM, Denomme GA

PMID: 28236294 [PubMed - as supplied by publisher]




Prioritizing of bacterial infections transmitted through substances of human origin in Europe.
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Prioritizing of bacterial infections transmitted through substances of human origin in Europe.

Transfusion. 2017 Feb 24;:

Authors: Domanović D, Cassini A, Bekeredjian-Ding I, Bokhorst A, Bouwknegt M, Facco G, Galea G, Grossi P, Jashari R, Jungbauer C, Marcelis J, Raluca-Siska I, Andersson-Vonrosen I, Suk JE

Abstract
BACKGROUND: Bacteria are the pathogens most frequently transmitted through substances of human origin (SoHO). The European Centre for Disease Prevention and Control (ECDC) organized an expert consultation, with the objective of developing a priority list of bacterial pathogens transmissible via SoHO. The list will be used to further assess risks and determine appropriate preventive measures.
STUDY DESIGN AND METHODS: The 14 most frequently SoHO-transmitted bacteria identified through a scoping literature review were then prioritized during an expert workshop through a methodology based on multicriteria decision analysis. The selection of the prioritization method was based upon an ECDC framework for best practices in conducting risk-ranking exercises. Three transmission pathways, blood and blood components, tissues and cells, and organs, were considered in the ranking exercise.
RESULTS: According to the ranking score (RS), bacteria were organized within each SoHO pathway into one of four risk tiers: Tier 1 (RS ≥ 0.70), Tier 2 (RS = 0.60-0.69), Tier 3 (RS = 0.40-0.59), or Tier 4 (RS < 0.40). The most consistently identified pathogens in the highest risk Tiers 1 and 2 of all three pathways were: Staphylococcus aureus, Klebsiella spp., Escherichia coli, β-hemolytic streptococci, Pseudomonas spp., and Acinetobacter spp.
CONCLUSION: Six bacteria were defined as being of the highest priority in respect of the threat to the safety of SoHO and will be the subject of subsequent in-depth risk assessments to be conducted by ECDC to identify measures to mitigate the risk posed by these bacteria.

PMID: 28236291 [PubMed - as supplied by publisher]




The impact of bowl size, program setup, and blood hematocrit on the performance of a discontinuous autotransfusion system.
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The impact of bowl size, program setup, and blood hematocrit on the performance of a discontinuous autotransfusion system.

Transfusion. 2017 Feb 24;:

Authors: Seyfried TF, Gruber M, Streithoff F, Mandle RJ, Pawlik MT, Busse H, Hansen E

Abstract
BACKGROUND: Cell salvage is an essential element in the concept of blood management. Modern devices provide different bowl sizes and sensor-directed programs to optimally adjust to varying clinical situations.
STUDY DESIGN AND METHODS: In an experimental performance study, the discontinuous autotransfusion device XTRA (LivaNova/Sorin) was evaluated using fresh donor blood anticoagulated with heparin 5 U/mL and adjusted to a hematocrit of 10% or 25%, representing orthopedic or cardiac surgery. Test blood was processed with the autotransfusion device XTRA in four different bowls (55 mL, 125 mL, 175 mL, and 225 mL) and in three different program modes (a standard program, an optimized program, and an emergency program).
RESULTS: Processing speed increased with bowl size and with the emergency program (range, 6.4-29.8 mL red blood cells [RBCs]/min). The RBC recovery rate exceeded 90% for all bowls and programs except the 55-mL bowl with the emergency program. Plasma elimination exceeded 95% for all bowls and programs except the 225-mL bowl with the emergency and standard programs. Maximal RBC recovery (range, 94.7%-97.6%) and plasma elimination (range, 98.7%-99.5%) were obtained with the medium-sized bowls (125 mL and 175 mL) and the optimized program. Elimination rates for potassium or plasma free hemoglobin were consistently lower than for protein or albumin and were highest for heparin.
CONCLUSIONS: Increased hematocrit and RBC recovery rates are obtained with the optimized program Popt with the discontinuous autotransfusion device. The emergency program Pem speeds up the process but leads to RBC loss and reduced plasma elimination rates; therefore, it should be restricted to emergency situations. All four different sized bowls have high performance. Plasma elimination is represented best by protein or albumin elimination rates.

PMID: 28233319 [PubMed - as supplied by publisher]