Comparison of transfusion-outcome in patients with massive bleeding receiving pathogen-reduced platelets prepared with two different technologies.

BACKGROUND: Platelet concentrates(PCs) prepared with pathogen reduction technologies(PRT) are being used in routine treatment of onco-haematological patients since several years but less data are available for other pathologies. STUDY DESIGN AND METHODS: The aim of the study was to compare the efficacy of PCs prepared with two PRT for the treatment of patients with massive bleeding. The primary endpoint was the overall survival and in addition we analyzed the consumption of blood components in patients undergoing massive transfusion(MT). Subsequently we wanted to analyze additional known factors associated with higher in-hospital mortality. Retrospective analysis of two consecutive periods in which the PRT used were INTERCEPT and Mirasol, respectively. RESULTS: A total of 313 patients were included (76 % males; median age: 63 years; 160 in the INTERCEPT group and 153 in the Mirasol group). We found significantly higher use of platelets in the Mirasol cohort, measured either in absolute per patient number of units (3vs.4; p = 0.002) or after adjustment for the number of transfused red blood cells. The risk of death increased with age and the outof-hospital onset of bleeding, even after adjustment for one another (sub-distribution hazard ratio[sHR] 2.53, 95 % confidence interval [CI] 1.75-3.66, p < 0.001, and sHR 2.56, 95 % CI 1.82-3.60, p < 0.001, respectively). CONCLUSION: PRT applied to platelets did not influence MT-related mortality, but differences were found for the efficacy of the PCs treated with the different PRT which were reflected in a heightened demand for transfusion when utilizing Mirasol-treated PCs. Factors associated with higher mortality were older age and out-of-hospital bleeding.

In vitro evaluation of pathogen inactivated platelet quality: An 8 year experience of routine use in Galicia, Spain.

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.