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 distribution and wastage rates were compared over the 10 months before and after approval for PR-PC to be stored for up to seven days. (3) Results: A 100% PR-PC inventory was achieved by increasing double apheresis collections and production of double doses using pools of two single apheresis units. Discard rates decreased from 6% to 3% after PR implementation and further decreased to 1.2% after seven-day storage extension for PR-PCs. The blood utilization remained stable, with no increase in component utilization. A significant decrease in adverse transfusion events was observed after the PR implementation. (4) Conclusion: Our experience demonstrates the feasibility for Brazilian blood centers to achieve a 100% PR-PC inventory. All patients at our hospital received PR-PC and showed no increase in blood component utilization and decreased rates of adverse transfusion reactions.

Evaluation of amotosalen and UVA pathogen‐reduced apheresis platelets after 7‐day storage

“…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.…”

“…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.…”

“…[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. This manuscript summarizes and integrates the experience with PRPC stored >5 days and was designed to evaluate the hypothesis that single-donor derived PRPCs stored for 7 days retain sufficient function for therapeutic transfusion efficacy.…”

“…Postmarket studies have documented clinical efficacy with reduced wastage and increased PC availability when compared with historical 5‐day‐stored PCs. 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 20–23 …”

Biochemical and functional characteristics of stored (double‐dose) buffy‐coat platelet concentrates treated with amotosalen and a prototype UVA light‐emitting diode illuminator

“…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.…”