Universal adoption of pathogen inactivation of platelet components: impact on platelet and red blood cell component use (original) (raw)
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International Journal of Pharmacy and Pharmaceutical Sciences, 2016
Objective: In the Brazilian public health system, sterile filtration is often used to prevent infections associated with platelet transfusion. The literature addressing this issue indicates that pathogen inactivation could be incorporated as an alternative to the development of individual tests and blood donor selection. The objective was to assess whether the use of platelets submitted to pathogen inactivation by photochemical methods could decrease the incidence of post-transfusion infections by viruses, bacteria or other pathogens compared to the use of platelet concentrate or platelets extracted by apheresis without photochemical treatment. Methods: A literature review from 1998 to 2015 was conducted. The scientific literature was surveyed using six electronic databases, two Internet search tools and a manual search of references, using specific search strategies for each database. The selected studies were assessed for quality according to a specific methodology. Data analysis was performed by observations made from the efficacy of the methods. Results: From a detailed analysis of 426 articles retrieved, 10 articles were selected for this review. Among the selected studies, seven studies were clinical trials, and three studies were systematic reviews in combination with meta-analysis. The outcomes analyzed included the reduction of the residual risk in pathogen transmission, mortality, occurrence of hemorrhagic events, corrected count increment (CCI) after 1 h, CCI after 24 h, and transfusion reactions. Conclusion: Differences were found in the quality of the included studies. Systematic reviews conducted on this topic, in alliance with political, social and administrative factors, will aid decision makers regarding its incorporation into the Brazilian Health System.
Cost-effectiveness of pathogen inactivation for platelet transfusions in the Netherlands
Transfusion Medicine, 2005
The objective of this study is to estimate cost-effectiveness of pathogen inactivation for platelet transfusions in the Netherlands. We used decision tree analysis to evaluate the cost-effectiveness of the addition of pathogen inactivation of pooled platelets to standard procedures for platelet transfusion safety (such as, donor recruitment and screening). Data on transfusions were derived from the University Medical Centre Groningen (the Netherlands) for 1997. Characteristics of platelet recipients (patient group, age, gender and survival) and data/assumptions on viral and bacterial risks were linked to direct and indirect costs/benefits of pathogen inactivation. Post-transfusion survival was simulated with a Markov model. Standard methods for cost-effectiveness were used. Cost-effectiveness was expressed in net costs per life-year gained (LYG) and estimated in baseline-and sensitivity analysis. Sensitivity was analysed with respect to various assumptions including sepsis risk, reduction of the discard rate and discounting. Stochastic analysis to derive 90% simulation intervals (SIs) was performed on sepsis risk. Net costs per LYG for pathogen inactivation were estimated E554 000 in the baseline-weighted average over the three patient groups (90% SI: E354 000-1092 500). Sensitivity analysis revealed that costeffectiveness was insensitive to viral risks and indirect costing, but highly sensitive to the assumed excess transfusions required and discounting of LYG. Given relatively high net costs per LYG that are internationally accepted for blood transfusion safety interventions, our estimated cost-effectiveness figures for pathogen inactivation may reflect acceptable costeffectiveness in this specific area. Two main assumptions of our model were that the pathogen inactivation was 100% effective in preventing transmission of the pathogens considered and was not associated with major and/or costly adverse reactions. Validation of several crucial parameters is required, in particular the Dutch risk for acquiring and dying of transfusionrelated sepsis.
Transfusion and Apheresis Science, 2018
Background: Platelet concentrates (PCs) treated by the pathogen inactivation technology (PI) using amotosalen and UVA illumination (PI-PCs) can be manufactured in additive solutions (PAS-III and PAS-IIIM) or in 100% Plasma. Quality control (QC) is an integral part of the production. We capitalized on our ongoing QC program to capture 8 years-worth of data on parameters related to the quality of 116,214 PI-PCs produced under different manufacturing methods. Materials and methods: Selected in vitro parameters of metabolism, activation, and storage were analyzed for the different manufacturing periods to compare PI-PCs versus conventional PCs (C-PCs) resuspended in different PAS. Results and discussion: All BC-PCs met quality standards for pH and dose and residual leucocytes. As expected, storage time correlated with increased lactate, LDH, Annexin V, CD62, sCD40 L levels and decreased glucose and pH. With PAS-IIIM, higher levels of glucose were observed toward the end of shelf life (p < 0.0001) with lower platelet activation markers Annexin V (p = 0.038) and CD62 (p = 0.0006). Following PI implementation, a low expire rate of < 0.5% was observed. While a 2.3% mean increase in the production of PCs occurred from 2011 to 2015, the distribution of red blood cell concentrates dropped by 4.4%. A mean incidence of 0.14% for transfusion-related adverse reaction was observed while PI-PCs were distributed, similar to the one observed with C-PCs. Overall, PI-PCs prepared in additive solutions consistently met quality standards. Those prepared in PAS-IIIM appeared to have better retention of in vitro characteristics compared to PAS-III though all demonstrated functionality and clinical effectiveness.
Platelet concentrates: reducing the risk of transfusion-transmitted bacterial infections
International Journal of Clinical Transfusion Medicine, 2014
The introduction of a combination of interventions during collection of whole-blood or platelet concentrates has been successful in lowering the degree of bacterial contamination in the final product, the platelet concentrate, by 50%-75%. These interventions were improved donor questionnaires, best-practice skin disinfection, and diversion of first blood volume. These interventions have reduced the number of bacteria present in the platelet concentrates. In combination with screening for bacterial contamination of platelet concentrates with a culture method, the degree of transfusion-transmitted bacterial infection has been reduced significantly. Due to the very low initial bacteria counts upon collection of the products, the need for improved sensitivity of early screenings tests or highly selective point-of-issue tests remains. The latter should be rapid and easy to perform. An alternative approach might be the implementation of pathogen-inactivation methods for cellular blood products to reduce the amount of pathogens. However, these methods are costly, and so far not proved to be cost-effective, especially in countries with an already-low incidence of transfusion-transmitted infections by viruses, parasites, or bacteria.