2021
DOI: 10.3390/pathogens10111499
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The 4-Year Experience with Implementation and Routine Use of Pathogen Reduction in a Brazilian Hospital

Abstract: (1) Background: We reviewed the logistics of the implementation of pathogen reduction (PR) using the INTERCEPT Blood System™ for platelets and the experience with routine use and clinical outcomes in the patient population at the Sírio-Libanês Hospital of São Paulo, Brazil. (2) Methods: Platelet concentrate (PC), including pathogen reduced (PR-PC) production, inventory management, discard rates, blood utilization, and clinical outcomes were analyzed over the 40 months before and after PR implementation. Age di… Show more

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Cited by 5 publications
(7 citation statements)
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“…With effective inactivation of a range of bacterial strains and demonstrated sterility at outdate, [46][47][48] many countries across Europe, Asia, and Latin America permit PRPC storage for up to 7 days before transfusion, facilitating improved platelet logistics, increased availability, and reduced wastage. 23,49 The efficacy of 6-7-day-stored amotosalen-UVA buffy-coat derived platelets was demonstrated in a Phase 3 RCT 5 that confirmed noninferiority of the 1-h corrected count increment (CCI) compared with conventional platelets. Post-transfusion bleeding, RBC use, and the median time to the next PC transfusion after the study PC were not different.…”
Section: Discussionmentioning
confidence: 92%
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“…With effective inactivation of a range of bacterial strains and demonstrated sterility at outdate, [46][47][48] many countries across Europe, Asia, and Latin America permit PRPC storage for up to 7 days before transfusion, facilitating improved platelet logistics, increased availability, and reduced wastage. 23,49 The efficacy of 6-7-day-stored amotosalen-UVA buffy-coat derived platelets was demonstrated in a Phase 3 RCT 5 that confirmed noninferiority of the 1-h corrected count increment (CCI) compared with conventional platelets. Post-transfusion bleeding, RBC use, and the median time to the next PC transfusion after the study PC were not different.…”
Section: Discussionmentioning
confidence: 92%
“…Furthermore, in routine practice there has been minimal change in RBC, plasma, or platelet usage attributed to the introduction of PRPCs, despite evidence of reduced platelet count increments when compared with untreated conventional platelets. [20][21][22][23] The therapeutic efficacy of PRPCs stored for 6-7 days is supported by a Phase 3 RCT 5 and by postmarket experience. [20][21][22][23][24][25] Further studies presented in this manuscript support transfusion of PRPCs through 7 days of storage: Phase 1 studies evaluated the post-storage in vitro platelet properties of apheresis PRPCs suspended in 65% PAS-3/35% plasma or 100% plasma (Test) compared to untreated conventional platelets from the same donor (Control) and stored for 7 days; thrombin generation of conventional or PRPCs stored for 7 days in 100% plasma; and a Phase 2 study comparing the in vivo post-infusion radiolabeled recovery and survival of PRPCs suspended in 100% plasma and stored for 7 days, with fresh autologous platelets prepared from platelet-rich plasma (PRP) isolated from whole blood.…”
Section: Introductionmentioning
confidence: 98%
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“…Notably, the clinical hemostasis efficacy of INTERCEPT-treated PCs stored for 6-7 days when compared with historical 5-day-stored PCs has been documented in a Phase 3 randomized controlled trial 27 and extensive post-market experience at sites that routinely store for up to 7 days. [28][29][30][31] Since 7-day stored LEDtreated platelets displayed identical in vitro quality to those of 7-day stored UVA lamp-treated platelets, it is reasonable to anticipate that 7-day stored LED-treated platelets would survive in vivo at similar levels. Randomized clinical trials and post-marketing studies measuring the posttransfusion increments in platelet counts, time between platelet transfusion, and numbers of PC units transfused remain essential to evaluate their clinical efficacy.…”
Section: Discussionmentioning
confidence: 99%