Pathogen-reduced Platelets Research Articles

Introduction of 7-day amotosalen/ultraviolet A light pathogen-reduced platelets in Honduras: Impact on platelet availability in a lower middle-income country.

Honduras became the first lower middle-income country (LMIC) to adopt amotosalen/UVA pathogen-reduced (PR) platelet concentrates (PCs) as a national platelet safety measure in 2018. The Honduran Red Cross (HRC) produces ~70% of the national platelet supply using the platelet-rich plasma (PRP) method. Between 2015 and 2018, PCs were screened with bacterial culture and issued as individual, non-pooled PRP units with weight-based dosing and 5-day shelf-life. PR PCs were produced in six-PRP pools with a standardized dose (≥3.0 × 1011), no bacterial screening and 7-day shelf-life. Gamma irradiation and leukoreduction were not used. PC production and distribution data were retrospectively analysed in two periods. Period 1 (P1) included 3 years of PRP PCs and a transition year (2015-18). Period 2 (P2) included 5 years of PR PCs (2019-23). PC doses were standardized to an equivalent adult dose for both periods. Descriptive statistics were calculated. HRC produced 10% more PC doses per year on average in P2 compared to P1. Mean annual waste at HRC declined from 23.9% in P1 to 1.1% in P2. Two urban regions consumed 96% of PC doses in P1 and 88.3% in P2. PC distributions increased in 14/18 regions. Standardized dosage, PR and 7-day shelf-life increased PC availability, reduced waste, eliminated bacterial screening and avoided additional costs for arboviral testing, leukoreduction and irradiation. Access to PC transfusion remains limited in Honduras; however, the conversion to pooled PR PCs illustrates the potential to sustainably expand PC distribution in an LMIC.

In vitro regenerative effects of a pooled pathogen-reduced lyophilized human cord blood platelet lysate for wound healing applications.

Cord blood platelets, easily obtained from blood units not suitable for haematopoietic stem cell transplantation, represent an abundant source of growth factors for use in wound healing. Although several protocols have been described for platelet lysate production, no standard manufacturing protocol is available. The use of pooled cord blood platelets could thus facilitate standardization. In this study, the effect of varying concentrations (up to 20%) of a pooled pathogen-reduced lyophilized cord blood platelet lysate (PRL-CBPL) was investigated in different cell types involved in the wound healing process. The effect of heparin addition was also evaluated. In parallel, a comparison was performed with a single donor cord blood platelet lysate (SD-CBPL). The effect of PRL-CBPL on the viability and proliferation of different cell lines (L929 mouse fibroblasts and HaCaT keratinocytes) and human primary cells (fibroblasts-NHDF, coronary artery smooth muscle cells-HCASMC and coronary artery endothelial cells-HCAEC), on HaCaT migration and the chemotactic effect on human monocytes (THP-1) was evaluated. PRL-CBPL showed a lower PDGF-AB amount compared to SD-CBPL. Differing concentrations of both CBPL were necessary to influence cell viability and proliferation. 3% was the optimal concentration for L929 and HaCaT as well as for NHDF and HCASMC, while HCAEC required 10%. The effect of added heparin was more evident on SD-CBPL and in particular on NHDF and HCASMC proliferation. Keratinocyte scratch closure was obtained with 3 and 5% PRL-CBPL and SD-CBPL respectively. Both CBPLs caused an increase in the number of migrated THP-1 monocytes in a concentration-dependent manner up to 20% with a higher monocyte migration for SD-CBPL with respect to PRL-CBPL and in cells treated with heparin. The data obtained suggest that PRL-CBPL is an effective standardized alternative to SD-CBPL.

Isohemagglutinin titration in pooled and apheresis platelets.

Platelet inventory constraints necessitate ABO-incompatible platelet transfusion. Many minimize the hemolytic impact by confirming low titre (LT) donor isohemagglutinins. This process is costly. Pathogen-reduced platelets (PRP) in platelet additive solutions (PAS) will dilute plasma and decrease high-titre isohemagglutinins (HT). We determined the proportion of HT platelets and incompatible transfusions for units suspended in plasma to reassess the need for titres following introduction of PRP/PAS. Our titre method is manual tube (1:50) dilution of platelet supernatant from apheresis or whole blood derived buffy coat pools suspended in plasma, tested with A1/B red cells. Testing included 49,058 pooled and 11,738 apheresis platelets over 4 years. The HT proportion, rate of out-of-group transfusions, and hemolytic reactions were determined. The impact of PAS dilution was estimated. Totally 60,796 platelet units were tested. Group O pooled and group B apheresis platelets had HT in 6.6% and 5.7%, respectively. Group A pooled and apheresis platelets included 2% with HT. Approximately 25% of platelets transfused were ABO-incompatible and no hemolytic reactions were reported. Based on the proportions of PAS-E and plasma for PRP platelets, plasma from each donor comprises 11 mL (6% of total volume) vs 20-257 mL in untreated pools. PAS-E will replace and dilute residual plasma by at least 50%. Rare platelet pools may demonstrate HT. PRP platelets with PAS will reduce titres and may abrogate the need for titration. A strategy of group specific transfusion or transfusion of group A PRP platelet transfusions may be a safe alternative.

Acute pulmonary injury in hematology patients supported with pathogen-reduced and conventional platelet components

AbstractPatients treated with antineoplastic therapy often develop thrombocytopenia requiring platelet transfusion, which has potential to exacerbate pulmonary injury. This study tested the hypothesis that amotosalen-UVA pathogen–reduced platelet components (PRPCs) do not potentiate pulmonary dysfunction compared with conventional platelet components (CPCs). A prospective, multicenter, open-label, sequential cohort study evaluated the incidence of treatment-emergent assisted mechanical ventilation initiated for pulmonary dysfunction (TEAMV-PD). The first cohort received CPC. After the CPC cohort, each site enrolled a second cohort transfused with PRPC. Other outcomes included clinically significant pulmonary adverse events (CSPAE) and the incidence of treatment-emergent acute respiratory distress syndrome (TEARDS) diagnosed by blinded expert adjudication. The incidence of TEAMV-PD in all patients (1068 PRPC and 1223 CPC) was less for PRPC (1.7 %) than CPC (3.1%) with a treatment difference of –1.5% (95% confidence interval [CI], –2.7 to –0.2). In patients requiring ≥2 PCs, the incidence of TEAMV-PD was reduced for PRPC recipients compared with CPC recipients (treatment difference, –2.4%; 95% CI, –4.2 to –0.6). CSPAE increased with increasing PC exposure but were not significantly different between the cohorts. For patients receiving ≥2 platelet transfusions, TEARDS occurred in 1.3% PRPC and 2.6% CPC recipients (P = .086). Bayesian analysis demonstrated PRPC may be superior in reducing TEAMV-PD and TEARDS for platelet transfusion recipients compared with CPC recipients, with 99.2% and 88.8% probability, respectively. In this study, PRPC compared with CPC demonstrated high probability of reduced severe pulmonary injury requiring assisted mechanical ventilation in patients with hematology disorders dependent on platelet transfusion. This trial was registered at www.ClinicalTrials.gov as #NCT02549222.

Therapeutic efficacy and safety of pathogen-reduced platelet components: Results of a meta-analysis of randomized controlled trials.

Clinical efficacy and safety of pathogen-reduced platelet concentrates (PR-PCs) concerning bleeding prevention are still debated despite conclusive real-world data from multiple countries where PR-PCs are transfused routinely. We performed a meta-analysis of randomized controlled trials (RCTs) comparing the clinical efficacy and safety of conventional platelet components (PCs) and PR-PCs prepared with the amotosalen/ultraviolet A light (INTERCEPT platelet concentrate [I-PC]) or riboflavin/ultraviolet light (Mirasol platelet concentrate [M-PC]) technologies, transfused in thrombocytopenic adult patients. A literature search was conducted, and 10 RCTs met the criteria for inclusion in this meta-analysis. Summary odds ratios (ORs) of clinically significant bleeding (World Health Organization [WHO] bleeding grade ≥2), severe bleeding (WHO bleeding score ≥3) and all-cause mortality were calculated. The use of I-PC was not associated with an increase in the OR of clinically significant bleeding when compared to non-treated PCs (OR, 1.12; 95% CI: 0.89-1.41; p = 0.33), whereas transfusions with M-PC showed an increase in clinically significant bleeding (OR, 1.34; 95% CI: 1.03-1.75; p = 0.03). The OR of severe bleeding did not increase with either I-PC or M-PC (OR 0.88; 95% CI: 0.59-1.31; p = 0.52 for I-PC; OR 1.25; 95% CI: 0.66-2.37; p = 0.49 for M-PC). In the case of all-cause mortality, compared to non-treated PC, I-PC showed an OR of 0.61 (95% CI: 0.36-1.04; p = 0.07), and M-PC showed an OR of 3.04 (95% CI: 0.81-11.47; p = 0.1). No differences were observed concerning the clinical efficacy and safety of overall PR-PCs when compared to non-treated PCs. However, differences are evident when analysing platelets prepared with the two PR technologies independently.

Cold platelet transfusion: The effects of a fluid warmer on platelet function.

Recently the US Food and Drug Administration has granted variances to select blood centers to supply cold-stored platelet components (CSP). In hemorrhage resuscitation warming of blood components with approved fluid warming devices is common. Pathogen-reduced apheresis platelet units were collected and stored in one of two ways: (1) CSP-I, (2) CSP-D. CSP-I were collected and immediately stored at 1-6°C until used. CSP-D were collected and stored at 20-24°C for 5 days and transferred to storage at 1-6°C until use. Aggregometry using arachidonic acid (AA), adenosine diphosphate (ADP) and collagen as agonists was performed on the unit samples before and after the units were infused through a Ranger blood-warming device. CSP-I, 23 units, had very high aggregation responses to all agonists (all ≥47.6 ± 20.7). There was a statistically significant reduction in ADP-induced aggregometry results from 55.1 ± 23.2 before compared to 33.5 ± 14.6 following infusion of the PLT through the blood warmer (p < .001). There were no differences in AA and collagen aggregometry results before and after the infusion of the platelets through the blood warmer. CSP-D had 5 of the 15 units with visible clotting in the bag. The 10 CSP-Ds studied had lower aggregation than all agonists before and after infusion through the blood-warming device (all ≤49.9 ± 35.9). We detected a statistically significant reduction in ADP-induced aggregometry in CSP-I run through a Ranger blood-warming device with no change with AA or collagen agonist aggregometry.

P‐TS‐38 | Impact of Amotosalen/UVA Treatment for Pathogen Reduction in Platelet Concentrates on Transfusion Efficacy in Cardiac Surgery

P‐TS‐38 | Impact of Amotosalen/UVA Treatment for Pathogen Reduction in Platelet Concentrates on Transfusion Efficacy in Cardiac Surgery

Storage of pathogen-reduced platelets

Storage of pathogen-reduced platelets

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

BackgroundAmotosalen/UVA pathogen‐reduced platelet components (PRPCs) with storage up to 7 days are standard of care in France, Switzerland, and Austria. PRPCs provide effective hemostasis with reduced risk of transfusion‐transmitted infections and transfusion‐associated graft versus host disease, reduced wastage and improved availability compared with 5‐day‐stored PCs. This study evaluated the potency of 7‐day PRPCs by in vitro characterization and in vivo pharmacokinetic analysis of autologous PCs.Study Design and MethodsThe in vitro characteristics of 7‐day‐stored apheresis PRPCs suspended in 100% plasma or 65% platelet additive solution (PAS‐3)/35% plasma, thrombin generation, and in vivo radiolabeled post‐transfusion recovery and survival of 7‐day‐stored PRPCs suspended in 100% plasma were compared with either 7‐day‐stored or fresh autologous conventional platelets.ResultsPRPCs after 7 days of storage maintained pH, platelet dose, in vitro physiologic characteristics, and thrombin generation when compared to conventional 7‐day PCs. In vivo, the mean post‐transfusion survival was 151.4 ± 20.1 h for 7‐day PRPCs in 100% plasma (Test) versus 209.6 ± 13.9 h for the fresh autologous platelets (Control), (T‐ΔC: 72.3 ± 8.8%: 95% confidence interval [CI]: 68.5, 76.1) and mean 24‐h post‐transfusion recovery 37.6 ± 8.4% for Test versus 56.8 ± 9.2% for Control (T‐ΔC: 66.2 ± 11.2%; 95% CI: 61.3, 71.1).DiscussionPRPCs collected in both 100% plasma as well as 65% PAS‐3/35% plasma and stored for 7 days retained in vitro physiologic characteristics. PRPCs stored in 100% plasma for 7 days retained in vivo survival. Lower in vivo post‐radiolabeled autologous platelet recovery is consistent with reported reduced count increments for allogenic transfusion.

Efficacy and Safety of Pathogen-Reduced Platelets Compared with Standard Apheresis Platelets: A Systematic Review of RCTs.

In this systematic review, we evaluate the efficacy and safety of blood components treated with pathogen reduction technologies (PRTs). We searched the Medline, Embase, Scopus, Ovid, and Cochrane Library to identify RCTs evaluating PRTs. Risk of bias assessment and the Mantel–Haenszel method for data synthesis were used. We included in this review 19 RCTs evaluating 4332 patients (mostly oncohematological patients) receiving blood components treated with three different PRTs. Compared with standard platelets (St-PLTs), the treatment with pathogen-reduced platelets (PR-PLTs) does not increase the occurrence of bleeding events, although a slight increase in the occurrence of severe bleeding events was observed in the overall comparison. No between-groups difference in the occurrence of serious adverse events was observed. PR-PLT recipients had a lower 1 and 24 h CI and CCI. The number of patients with platelet refractoriness and alloimmunization was significantly higher in PR-PLT recipients compared with St-PLT recipients. PR-PLT recipients had a higher number of platelet and RBC transfusions compared with St-PLT recipients, with a shorter transfusion time interval. The quality of evidence for these outcomes was from moderate to high. Blood components treated with PRTs are not implicated in serious adverse events, and PR-PLTs do not have a major effect on the increase in bleeding events. However, treatment with PRTs may require a greater number of transfusions in shorter time intervals and may be implicated in an increase in platelet refractoriness and alloimmunization.

Residual risks of bacterial contamination for pathogen-reduced platelet components.

Platelet components are commonly transfused to patients for a variety of indications, including patients with low platelet counts or patients with platelet dysfunction who are bleeding or at high risk of bleeding. Although the risk of pathogen contamination of platelet components has declined significantly over the last 40 years, it remains a concern for the patients, for blood banks and for physicians. Pathogen inactivation (PI) technologies have been developed to mitigate this risk. This review focuses on the residual risks of transfusion-transmitted bacterial infections by platelet transfusion after PI. We describe and assess the relationship between the bacterial load and the timing and capacity of reduction of the different PI technologies, as well as the risks that could represent spore-forming microorganisms and the possible introduction of microorganisms after PI.

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

BackgroundPlatelet 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 methodsThe 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. ResultsA 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). ConclusionPRT 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.

The impact of pathogen-reduced platelets in acute leukaemia treatment on the total blood product requirement: a subgroup analysis of an EFFIPAP randomised trial.

To evaluate the impact of pathogen-reduced (PR) platelet transfusions on blood products requirement for clinical practice. PR platelets are increasing in use as standard blood products. However, few randomised trials have evaluated their impact on bleeding control or prevention. Furthermore, PR platelets recirculate less than untreated platelets. A subgroup study of the randomised clinical trial EFFIPAP compared three arms of platelet preparations (PR: P-PRP/PAS, additive solution: P-PAS and plasma P-P arms respectively). The subgroup of acute leukaemia patients, in their chemotherapy induction phase, included 392 patients (133 P-PRP/PAS arm, 132 P-PAS arm and 130 P-P arm). Blood requirements were analysed across over periods of 7 days. The number of platelet transfusions per week was significantly higher in the P-PRP/PAS group 2.3 [1.6-3.3] compared to the control groups 1.9 [1.3-2.8] and 2.0 [1.3-3.0] for P-P and P-PAS groups respectively (p < 0.0001). However, the total number of platelets transfused per week was not different. The number of red blood cell concentrates (RBC) transfusion per week did not differ either. In a homogeneous group of patients, platelet pathogen reduction resulted in an increased number of platelet units transfused per week while having no impact on the total number of platelets transfused or the number of RBC transfusion; resulting to an average requirement of 2 RBC and 2-3 platelets transfusions per week of marrow aplasia.

Transfusion-Transmitted Hepatitis A Virus, France, 2018.

We report a transfusion-transmitted hepatitis A virus infection in an immunocompromised patient in France, detected shortly after a transfusion of pathogen-reduced pooled platelets. This case raises questions about the efficacy of donor screening methods. Additional safety measures, such as routine donation screening, should be considered.

Hemostatic efficacy of pathogen-reduced platelets in children undergoing cardiopulmonary bypass.

Pediatric patients undergoing cardiopulmonary bypass (CPB) often require blood component transfusions. Pathogen-reduction (PR) of platelets reduces the risk of microbial contamination; however, its effect on hemostatic efficacy in this population is unclear. This study sought to characterize the hemostatic efficacy of PR platelets in children undergoing CPB. We performed a retrospective chart review of patients admitted to a pediatric intensive care unit following CPB surgery from 2015 to 2019. Demographic data, validated scoring of repair complexity, products received, and outcomes were compared. The primary outcome was postoperative chest tube bleeding. A total of 140 patients were enrolled. The majority of surgeries (124/140) were Risk Adjustment for Congenital Heart Surgery (RACHS) 1-3 repairs. Seventy-four percent of patients (104/140) received only standard platelets whereas 26% (36/140) received PR platelets. There were no differences between the groups in the age (p= .90), sex (p= .20) or RACHS score (p= .06). Postoperatively, there was no difference in the median chest tube output for 1h (p= .27), 2h (p= .26), 4h (p= .09), 8h (p= .16), or for the first 24 h following surgery (p= .23) in patients who received standard versus PR platelets. There was also no difference in receipt of platelets (p= .18), cell saver (p= .79), or cryoprecipitate (p= .28). Patients receiving PR platelets did not have more blood loss or require more transfusions than those who received standard platelets. This suggests that PR platelets may provide acceptable hemostasis with the additional benefits of reduced risk of microbial contamination in pediatric patients undergoing CPB.

How do I implement pathogen-reduced platelets?

Several risk mitigation steps have improved the safety of platelets in regard to bacterial contamination, but this continues to be a concern today. A Food and Drug Administration (FDA) Guidance issued in December 2018 aims to further limit this risk. The guidance offers multiple pathways for compliance, and hospital blood banks will have to collaborate with blood donor centers to assess various factors before deciding which method is most appropriate for them. Our institution considered several factors before moving forward with pathogen reduction technology. This included an assessment of platelet shelf-life, bacterial testing requirements, the efficacy of low-yield platelets, and managing a mixed platelet inventory. The decision to transition to pathogen-reduced platelets was associated with complex collection and processing limitations that resulted in either an increase in platelets that were over-concentrated or products with a low platelet yield. Through trials of various collection settings with unique target volumes and target platelet yields, our blood donor center was able to optimize the production. At the hospital end, this transition required a thorough review of low-yield platelet products and their clinical efficacy. Additionally, this implementation necessitated collaboration with clinical colleagues, comprehensive education, and training. Pathogen-reduced platelets would be the most efficient way for our institution to be compliant. This summary may serve as a roadmap for other institutions that are considering which FDA prescribed method to use and provide support for those that have decided on pathogen reduction technology but need to optimize their collections to best utilize low-yield products.

Current state and positive impact of hospital-based blood donor centers in the United States.

The COVID-19 pandemic has brought tremendous challenges to the United States blood supply. Decreased collections have caused blood product shortages. The number of hospital-based donor centers (HBDCs) has decreased in the past decades, but they provide important support to their hospital systems. We identified 79 active HBDCs through an information request to the FDA. These centers were invited to participate in a survey about their activities, blood product collections, and perceived value. Thirty-six centers responded (46% response rate). The centers represented a wide range of states and geographic settings. Whole blood collection was most common, but some respondents also prepared specialized products such as COVID-19 convalescent plasma and pathogen-reduced platelets. Positive impacts of HBDCs included inventory availability, cost-effectiveness/savings, community outreach, supporting special patient populations, and collecting specialty products. All respondents anticipate at least stable operations, if not growth, in the future. HBDCs continue to be valuable assets in addressing emerging patient transfusion needs. Their unique offerings are tailored to the populations their hospitals support, and demonstrate the value in having the collection infrastructure in place to rapidly respond to critical shortages. This survey provides benchmark data about a broad group of HBDCs including products prepared, inventory self-sufficiency levels, and reasons for positive impact.

Pathogen-reduced platelets in pediatric and neonatal patients: Demographics, transfusion rates, and transfusion reactions.

Pathogen-reduced platelets (PR PLT) are the emerging standard for proactive transfusion-transmitted infection (TTI) mitigation. There is, however, continued hesitation to transfuse PR PLT in children due to limited published data. We report demographics, rates of transfusion, and transfusion reactions (TR) associated with FDA-approved PR PLT in pediatric and neonatal patients at an academic medical center. Retrospective review was performed for patients <18 years receiving at least one platelet over a 300-day period at a large, tertiary care hospital. Patients were transfused PR or conventional (CONV) PLT, based on inventory availability. Statistical analysis was performed using Fisher Exact Test. During the study period, 191 patients received 1010 platelet transfusions (892 units). Sixty-eight patients received PR PLT only (1.3 units/patient, 95% confidence interval [CI] 1.1-1.5; 1.8 transfusions/patient, 95% CI 1.4-2.2), and 56 patients received CONV PLT only (1.4 units/patient, 95% CI 1.1-1.7; 1.6 transfusions/patient, 95% CI 1.3-1.9). Patients with hematologic malignancies undergoing chemotherapy/radiation and allogeneic hematopoietic stem cell transplant received the most platelet transfusions and more commonly received both platelet types. Of 506 PR PLT units, 5 TRs occurred; 386 CONV PLT resulted in two TRs (p=.7052). Of 51 neonates, 37 received PR PLT without adverse events, including 13 receiving phototherapy. No TTIs were identified in any group. There was no significant difference in rates of transfusion or TRs between PR and CONV PLT. Our study provides additional evidence that PR PLT can be transfused to pediatric and neonatal patients without increasing the risk of acute adverse events.

Pathogen reduction of platelets: experience of a single blood bank

: Pathogen reduction technology (PRT) has the potential to prevent pathogen transfusion transmission from blood donor to patient by impeding the replication of bacteria, viruses and parasites in blood components. Additionally, PRT can help to guarantee blood safety in challenging situations for blood supply, as in the Ebola or Chikungunya epidemics, or in a scenario full of uncertainties such as the current SARS-CoV-2 pandemic. The Balearic Islands Blood Bank (BIBB) is one of the few blood establishments worldwide with more than 10 years of experience in the routine use of amotosalen/UVA (Intercept Blood System) and riboflavin/UVA-UVB (Mirasol PRT system) for platelets (PLTs), the use of riboflavin/UVA-UVB for plasma and with research experience in riboflavin/UVA-UVB applied to whole blood. Over the years, we have had the opportunity to evaluate PRT from different perspectives, such as clinical and hemovigilance research in adults and children, in vitro studies on PRT effects on PLTs and assessing the financial impact of PRT implementation. PRT methods offer remarkable benefits but also have certain limitations, which are important to bear in mind during the decision-making process for PRT implementation. The purpose of this study is to review the current knowledge on PRT for PLTs drawing on our experience acquired over the last decade.

Transfusion-related adverse reactions: Data from the National Healthcare Safety Network Hemovigilance Module - United States, 2013-2018.

Despite current blood safety measures, transfusion recipients can experience transfusion-related adverse reactions. Monitoring these reactions can aid in understanding the effectiveness of current transfusion safety measures. Data from the National Healthcare Safety Network Hemovigilance Module were used to quantify adverse reaction risk. Facilities reporting at least one month of transfused blood components and transfusion-related adverse reactions during January 2013-December 2018 were included. Adverse reaction rates (number per 100,000 components transfused) were calculated for transfused components stratified by component type, collection, and modification methods. During 2013-2018, 201 facilities reported 18,308 transfusion-related adverse reactions among 8.34 million blood components transfused (220/100,000). Adverse reactions were higher among apheresis (486/100,000) and pathogen-reduced platelets (579/100,000) than apheresis red blood cells (197/100,000). Allergic reactions (41%) were most common. There were 23 fatalities and 9% of all adverse reactions were serious (severe, life-threatening, or fatal). Reactions involving pulmonary complications (transfusion-associated circulatory overload, transfusion-related acute lung injury and transfusion-associated dyspnea) accounted for 35% of serious reactions but 65% of fatalities. Most (76%) of the 37 transfusion-transmitted infections were serious; none involved pathogen-reduced components. One in 455 blood components transfused was associated with an adverse reaction although the risk of serious reactions (1 in 6224) or transfusion-transmitted infections (1 in 225,440) was lower. Some serious reactions identified were preventable, suggesting additional safety measures may be beneficial. Higher reaction rates identified among pathogen-reduced platelets require further study. These findings highlight the importance of monitoring reactions through national hemovigilance to inform current safety measures and the need for strategies to increase healthcare facility participation.