A national surveillance system for continuous monitoring of blood transfusion safety: German haemovigilance data.

BACKGROUND AND OBJECTIVES: Haemovigilance (HV) systems aim to improve transfusion outcomes in patients and donor safety. An important question for blood regulators is how to ensure an effective HV system. MATERIALS AND METHODS: We retrospectively analysed the HV reports submitted to Paul-Ehrlich-Institut over the last two decades. RESULTS: Between 2011 and 2020, 50.86 million units of blood components were used, and 8931 suspected serious donor and recipient adverse reactions (SARs), 874 serious adverse events (SAEs) and 12,073 donor look-backs were reported. Following implementation of specific risk-minimization measures (RMMs) between 2000 and 2010, SAR reporting rates decreased for transfusion-transmitted viral infections (TTVIs), transfusion-related acute lung injury (TRALI) and transfusion-transmitted bacterial infections (TTBIs), while increasing for other serious adverse transfusion reactions. Within this decade, the overall blood component use decreased. CONCLUSION: Long-term data collection forms the basis to establish trends and changes in reporting and to evaluate the effect of RMM. Standardized criteria for reaction types, seriousness and imputability assessments and availability of a denominator are important elements. Central data collection and independent assessment allow for monitoring HV data in a nationwide context over time. Stakeholder involvement and transparent feedback on the benefit of RMM will help to achieve the objectives of HV.

Review of haemovigilance at the Rabat Regional Blood Transfusion Centre in Morocco (2017-2021).

Introduction: blood transfusion remains an essential therapeutic intervention, but the occurrence of transfusion reactions makes its administration even more complex. Vigilant reporting of such reactions by recipients of blood products is essential for effective haemovigilance. This study aimed to determine the frequency and nature of transfusion reactions. Methods: conducted over five years (2017-2021) at the Haemovigilance Department of the Rabat Regional Blood Transfusion Centre, this retrospective study exploited incident forms notified by health establishments and data from the regional blood transfusion centre's computer system. Results: from 1 January 2017 and 31 December 2021, the Rabat Regional Blood Transfusion Centre distributed 435,651 labile blood products to various healthcare establishments, which reported 191 transfusion reactions involving 191 patients. The median age of the patients was 44.3 years, with an overall cumulative incidence of transfusion reactions of 0.44 per 1000 labile blood products delivered. The predominant reactions were non-haemolytic febrile and allergic reactions, accounting for 41.36% and 35.60% respectively. Grade 1 reactions accounted for 87% of all reactions recorded. During the study period, three deaths were recorded, with ABO incompatibility and transfusion-related acute lung injury (TRALI) accounting for two and one case respectively. Transfusion reactions involving erythrocyte components were significantly more frequent than those involving platelet and plasma components. Conclusion: this study revealed a relatively low incidence of transfusion reactions (0.44%), dominated by non-haemolytic febrile and allergic reactions. Several levels of failure were identified, in particular under-reporting of reactions and inadequate training in transfusion practices and haemovigilance, as well as the need for an effective electronic transfusion reaction reporting system to facilitate reporting and identification of underlying problems and risk factors to improve the quality of transfusion care provided to patients.

The incidence of transfusion-related acute lung injury using active surveillance: A systematic review and meta-analysis.

BACKGROUND: Transfusion-related acute lung injury (TRALI) is a leading cause of transfusion-related mortality. A concern with passive surveillance to detect transfusion reactions is underreporting. Our aim was to obtain evidence-based estimates of TRALI incidence using meta-analysis of active surveillance studies and to compare these estimates with passive surveillance. STUDY DESIGN AND METHODS: We performed a systematic review and meta-analysis of studies reporting TRALI rates. A search of Medline and Embase by a research librarian identified studies published between January 1, 1991 and January 20, 2023. Prospective and retrospective observational studies reporting TRALI by blood component (red blood cells [RBCs], platelets, or plasma) were identified and all inpatient and outpatient settings were eligible. Adult and pediatric, as well as general and specific clinical populations, were included. Platelets and plasma must have used at least one modern TRALI donor risk mitigation strategy. A random effects model estimated TRALI incidence by blood component for active and passive surveillance studies and heterogeneity was examined using meta-regression. RESULTS: Eighty studies were included with approximately 176-million blood components transfused. RBCs had the highest number of studies (n = 66) included, followed by platelets (n = 35) and plasma (n = 34). Pooled TRALI estimates for active surveillance studies were 0.17/10,000 (95% confidence intervals [CI]: 0.03-0.43; I2 = 79%) for RBCs, 0.31/10,000 (95% CI: 0.22-0.42; I2 = <1%) for platelets, and 3.19/10,000 (95% CI: 0.09-10.66; I2 = 86%) for plasma. Studies using passive surveillance ranged from 0.02 to 0.10/10,000 among the various blood components. DISCUSSION: In summary, these estimates may improve a quantitative understanding of TRALI risk, which is important for clinical decision-making weighing the risks and benefits of transfusion.

Standardized reporting of pulmonary transfusion complications: Development of a model reporting form and flowchart.

BACKGROUND: Pulmonary complications of blood transfusion, including transfusion-related acute lung injury (TRALI), transfusion-associated circulatory overload (TACO), and transfusion-associated dyspnea, are generally underdiagnosed and under-reported. The international TRALI and TACO definitions have recently been updated. Currently, no standardized pulmonary transfusion reaction reporting form exists and most of the hemovigilance forms have not yet incorporated the updated definitions. We developed a harmonized reporting form, aimed at improved data collection on pulmonary transfusion reactions for hemovigilance and research purposes by developing a standardized model reporting form and flowchart. MATERIALS AND METHODS: Using a modified Delphi method among an international, multidisciplinary panel of 24 hemovigilance experts, detailed recommendations were developed for a standardized model reporting form for pulmonary complications of blood transfusion. Two Delphi rounds, including scoring systems, took place and several subsequent meetings were held to discuss issues and obtain consensus. Additionally, a flowchart was developed incorporating recently published redefinitions of pulmonary transfusion reactions. RESULTS: In total, 17 participants completed the first questionnaire (70.8% response rate) and 14 participants completed the second questionnaire (58.3% response rate). According to the results from the questionnaires, the standardized model reporting form was divided into various subcategories: general information, patient history and transfusion characteristics, reaction details, investigations, treatment and supportive care, narrative, and transfused product. CONCLUSION: In this article, we present the recommendations from a global group of experts in the hemovigilance field. The standardized model reporting form and flowchart provide an initiative that may improve data collected to address pulmonary transfusion reactions.

The impact of revised definitions for transfusion-associated circulatory overload and transfusion-related acute lung injury on haemovigilance reporting.

BACKGROUND AND OBJECTIVES: Transfusion-associated circulatory overload (TACO) and transfusion-related acute lung injury (TRALI) are serious adverse transfusion reactions. Standardized surveillance definitions are important to ensure consistent reporting of cases. Recently, revised definitions have been developed for TACO and TRALI, the latter of which has not yet been widely implemented. This study aimed to assess the impact of the new TACO and TRALI definitions on haemovigilance reporting. MATERIALS AND METHODS: The Australian Red Cross Lifeblood Adverse Transfusion Reaction database was accessed to identify all cases of suspected or confirmed TACO and TRALI referred from 1 July 2015 to 30 June 2019. Cases were assessed against both the former and new definitions and the results were compared. RESULTS: A total of 73 cases were assessed. There were 48 TACO cases identified. Only 26 of 48 cases strictly met the former 2011 International Society of Blood Transfusion (ISBT) definition of TACO; 6 cases did not meet the definition and 16 cases lacked sufficient clinical details. In comparison, 46 cases met the revised 2018 ISBT definition, with only 2 cases having insufficient details. There were 24 cases of TRALI according to the existing 2004 Canadian Consensus Conference (CCC) definition compared with 25 cases according to the proposed 2019 revised definition. CONCLUSION: The revised TACO definition captured more cases than the former definition. No significant differences were observed in the number of TRALI cases under the proposed new definition. This is the first study to provide validation data for the revised TRALI definition.

The epidemiology of transfusion-related acute lung injury: A scoping review and analysis.

BACKGROUND: The purpose of this scoping review was to identify available sources of evidence on the epidemiology of transfusion-related acute lung injury (TRALI) and whether meta-analysis on the incidence of TRALI is feasible. TRALI is a serious complication and the second leading cause of death related to blood transfusion. Estimates of the incidence of TRALI would provide a useful benchmark for research to reduce TRALI. STUDY DESIGN AND METHODS: We searched the Medline, EMBASE, and PubMed databases for publications related to the incidence of TRALI and hemovigilance. We included all studies irrespective of language or country. Both full-text articles and conference abstracts were included. Participants of the studies must all have received a blood transfusion. Reviews and case studies were excluded. RESULTS: We identified 427 articles or abstracts to include for review. More than half were abstracts, and the majority were published after 2010. Reported TRALI definitions varied, but only 27.2% of studies reported any definition for TRALI. TRALI rates were reported using different denominators, such as per blood unit (54.1%), patient (34.4%), and transfusion episode (14.8%). Study populations and contexts were mostly general (75.6% and 80.3%, respectively). There was also variation in study design with most being observational (90.6%) and only 13.1% of all studies used modern donor restriction policies. DISCUSSION: There was substantial variation in reporting in studies on TRALI incidence. Meta-analysis of TRALI rates may be feasible in specific circumstances where reporting is clear. Future studies should clearly report key items, such as a TRALI definition.

Transfusion-related acute lung injury (TRALI): a retrospective review of reported cases in Queensland, Australia over 20 years.

BACKGROUND: Transfusion-related acute lung injury (TRALI) is a rare but potentially fatal transfusion reaction. An effective haemovigilance programme is important in implementing successful and targeted risk reduction strategies. We aim to provide a summary of TRALI cases referred for investigation in Queensland (QLD) Australia from 1999 to 2019, describing the epidemiological and laboratory features of local TRALI cases. MATERIALS AND METHODS: A retrospective audit evaluated all cases reported to the QLD Australian Red Cross Lifeblood over the 20-year study period. Cases were categorised according to the 2004 Canadian consensus criteria. RESULTS: Of the 91 cases referred for investigation, expert review confirmed 30 of TRALI and 18 of possible TRALI. A total of 238 donors and 110 blood products were assessed in confirmed cases. TRALI affected patients of all ages. Most patients had underlying haematological malignancies (25%), surgery (15%) or liver disease (13%). TRALI incidence was measured at 1 in 130,000 per issued product in QLD. Red cells were transfused in 32 cases, platelets in 18 and plasma products in 21, with 16 cases involving multiple products. Following laboratory assessment, 23% of cases had findings supportive of antibody mediated TRALI and 21% as likely non-antibody mediated. Possible TRALI was identified in 37.5% of cases of which 25% were antibody mediated and 12.5% non-antibody mediated. Nine (18.5%) cases were uncategorised due to insufficient immunologic investigations. DISCUSSION: Rates of TRALI incidence measured are lower than those seen in many international studies. A reduction in confirmed cases has been noted over recent years, supporting the implementation of risk-reduction strategies. We report a relatively higher proportion of non-antibody mediated TRALI and possible TRALI cases in more recent years, suggesting the need to further understand the role of product age and biological risk modifiers.

Incidence of transfusion-related acute lung injury temporally associated with solvent/detergent plasma use in the ICU: A retrospective before and after implementation study.

BACKGROUND: Transfusion-related acute lung injury (TRALI) is a severe complication of plasma transfusion, though the use of solvent/detergent pooled plasma (SDP) has nearly eliminated reported TRALI cases. The goal of this study was to investigate the incidence of TRALI in intensive care units (ICU) following the replacement of quarantined fresh frozen plasma (qFFP) by SDP. STUDY DESIGN AND METHODS: A retrospective multicenter observational before-after cohort study was performed during two 6-month periods, before (April-October 2014) and after the introduction of SDP (April-October 2015), accounting for a washout period. A full chart review was performed for patients who received ≥1 plasma units and developed hypoxemia within 24 h. RESULTS: During the study period, 8944 patients were admitted to the ICU. Exactly 1171 quarantine fresh frozen plasma (qFFP) units were transfused in 376 patients, and respectively, 2008 SDP units to 396 patients after implementation. Ten TRALI cases occurred during the qFFP and nine cases occurred during the SDP period, in which plasma was transfused. The incidence was 0.85% (CI95%: 0.33%-1.4%) per unit qFFP and 0.45% (CI95%: 0.21%-0.79%, p = 0.221) per SDP unit. One instance of TRALI occurred after a single SDP unit. Mortality was 70% for patients developing TRALI in the ICU compared with 22% in patients receiving at least one plasma transfusion. CONCLUSION: Implementation of SDP lowered the incidence of TRALI in which plasma products were implicated, though not significantly. Clinically diagnosed TRALI can still occur following SDP transfusion. Developing TRALI in the ICU was associated with high mortality rates, therefore, clinicians should remain vigilant.

Transfusion-Related Acute Lung Injury During Liver Transplantation: A Scoping Review.

Liver transplantation is associated with significant blood loss, often requiring massive blood product transfusion. Transfusion-related acute lung injury (TRALI) is a devastating cause of transfusion-related deaths. While reports have investigated the general incidence of TRALI, the incidence of TRALI specifically following transfusion during liver transplant remains unclear. This scoping review summarizes existing literature regarding TRALI during the liver transplantation perioperative period. Databases were searched for all articles and abstracts reporting on TRALI after liver transplantation. Data collected included number of patients studied, patient characteristics, incidences of TRALI, TRALI characteristics, and patient outcomes. The primary outcome investigated was the incidence of TRALI in the setting of liver transplantation. Thirteen full-text citations were included in this review. The incidence of TRALI post-liver transplant was 0.68% (65 of 9,554). Based on reported transfusion data, patients diagnosed with TRALI received an average of 10.92 ± 10.81 units of packed red blood cells (pRBC), 20.05 ± 15.72 units of fresh frozen plasma, and 5.75 ± 10.00 units of platelets. Common interventions following TRALI diagnosis included mechanical ventilation with positive end-expiratory pressure, inhaled high-flow oxygen, inhaled pulmonary vasodilator, and pharmacologic treatment using pressors or inotropes, corticosteroids, or diuretics. Based on reported mortality data, 26.67% of patients (12 of 45) diagnosed with TRALI died during the postoperative period. This scoping review underscores the importance of better understanding the incidence and presentation of TRALI after liver transplant surgery. The clinical implications of these results warrant the development of identification and management strategies for liver transplant patients at increased risk for developing TRALI.

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

BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

Early safety indicators of COVID-19 convalescent plasma in 5000 patients.

BACKGROUNDConvalescent plasma is the only antibody-based therapy currently available for patients with coronavirus disease 2019 (COVID-19). It has robust historical precedence and sound biological plausibility. Although promising, convalescent plasma has not yet been shown to be safe as a treatment for COVID-19.METHODSThus, we analyzed key safety metrics after transfusion of ABO-compatible human COVID-19 convalescent plasma in 5000 hospitalized adults with severe or life-threatening COVID-19, with 66% in the intensive care unit, as part of the US FDA expanded access program for COVID-19 convalescent plasma.RESULTSThe incidence of all serious adverse events (SAEs), including mortality rate (0.3%), in the first 4 hours after transfusion was <1%. Of the 36 reported SAEs, there were 25 reported incidences of related SAEs, including mortality (n = 4), transfusion-associated circulatory overload (n = 7), transfusion-related acute lung injury (n = 11), and severe allergic transfusion reactions (n = 3). However, only 2 of 36 SAEs were judged as definitely related to the convalescent plasma transfusion by the treating physician. The 7-day mortality rate was 14.9%.CONCLUSIONGiven the deadly nature of COVID-19 and the large population of critically ill patients included in these analyses, the mortality rate does not appear excessive. These early indicators suggest that transfusion of convalescent plasma is safe in hospitalized patients with COVID-19.TRIAL REGISTRATIONClinicalTrials.gov NCT04338360.FUNDINGMayo Clinic, Biomedical Advanced Research and Development Authority (75A50120C00096), National Center for Advancing Translational Sciences (UL1TR002377), National Heart, Lung, and Blood Institute (5R35HL139854 and R01 HL059842), National Institute of Diabetes and Digestive and Kidney Diseases (5T32DK07352), Natural Sciences and Engineering Research Council of Canada (PDF-532926-2019), National Institute of Allergy and Infectious Disease (R21 AI145356, R21 AI152318, and AI152078), Schwab Charitable Fund, United Health Group, National Basketball Association, Millennium Pharmaceuticals, and Octapharma USA Inc.

Adverse transfusion reactions in transfused children.

Transfusion in paediatrics requires specific guidelines, because child physiology and pathology differ significantly as compared to adults. Adverse transfusion reactions in transfused children also vary in type and frequency, but there is a better understanding of these reactions in adults than in children. However, for the most frequent adverse transfusion reactions, the overall prevalence is higher in children than in adults, with the exception of post-transfusion red blood cell alloimmunisation, which is lower, excluding patients with haemoglobinopathies. In several studies, allergic reactions were the most frequently reported adverse transfusion reaction in paediatrics, and the platelet concentrate the most frequently implicated blood product. Early diagnosis of certain adverse transfusion reactions such as haemosiderosis, is essential in order to initiate the best therapy and obtain a good clinical outcome. The prevention of adverse transfusion reactions in children is required, but needs further clinical studies in paediatrics. Lastly, changes in technology, policy and clinical practices will improve transfusion safety in children.

Effect of storage of platelet concentrates in PAS-B, PAS-C, or plasma on transfusion reactions.

BACKGROUND: Reports on the clinical consequences of longer storage time of platelet concentrates are contradictory. The objective of this study was to assess whether longer storage times are associated with a higher risk of transfusion reactions. STUDY DESIGN AND METHODS: We gathered storage times of pooled platelet concentrates related to transfusion reactions reported to the national hemovigilance office from 2004 to 2015. These were combined with storage times of platelet concentrates in the reference population to compare incidences of transfusion-associated circulatory overload, transfusion-related acute lung injury, allergic reactions, febrile nonhemolytic reactions, and "other" reactions between storage time categories. RESULTS: A total of 567,053 platelet concentrates and 1870 transfusion reactions were analyzed. Among platelet additive solution (PAS)-B platelet recipients, the odds ratio of a storage time of 4 to 5 days compared to 1 to 3 days was 1.60 (95% confidence interval [CI], 1.17-2.18) for allergic, and 1.47 (1.09-1.98) for febrile reactions. For PAS-C platelet recipients, the odds ratio for allergic reactions was 3.78 (95% CI, 1.31-10.9) for 4 to 5 days, and 4.57 (95% CI, 1.57-13.4) for 6- to 7-day-old platelets when compared to 1- to 3-day-old units. In all other studied reaction types, no statistically significant association was observed in platelets in plasma, PAS-B, and PAS-C. CONCLUSIONS: In plasma platelets, longer storage time was not associated with a higher incidence of transfusion reactions. In PAS platelets, longer storage time was associated with higher transfusion reaction incidences, in particular for allergic reactions with both PAS fluids and febrile reactions with PAS-B. This indicates that the effect of storage time is different for different reaction types and depends on the storage fluid.

Transfusion-Associated Circulatory Overload and Transfusion-Related Acute Lung Injury: Etiology and Prevention.

Transfusion-related acute lung injury and transfusion-associated circulatory overload are characterized by acute pulmonary edema within 6 hours of blood transfusion. Despite recognition as the leading causes of transfusion-related mortality, they remain difficult to study due to underrecognition and nonspecific diagnostic criteria. Recent study has shown that inflammatory cytokines and cardiopulmonary biomarker may be useful in differentiating pulmonary transfusion reactions and furthering our understanding of their pathogenesis. It is clear that donor / component mitigation and patient blood management strategies have decreased the incidence of pulmonary transfusion reactions. Additional clinical and translational research focused on identifying at-risk transfusion recipients is needed to further prevent these frequently severe cardiopulmonary events.

Are we underestimating reverse TRALI?

BACKGROUND: Transfusion-related acute lung injury (TRALI) is a rare but serious adverse transfusion reaction and is known to be related to anti-human leukocyte antigen (HLA) or anti-human neutrophil antigen (HNA) antibodies in donor plasma. In 2016, four of eight reported TRALI cases could not be explained by donor antibodies. It is assumed that fewer than 10% of TRALI cases are triggered by anti-HLA or anti-HNA antibodies in the patient's plasma (reverse TRALI). STUDY DESIGN AND METHODS: Three cases of red blood cell (RBC)-associated and one case of granulocyte-associated TRALI were investigated. Data were collected on the clinical aspects of the patient and the concerned blood product. Patient's HLA antibodies were determined and the implicated donor was contacted for HLA typing. The HLA antibody identification and strength were assessed using a bead assay (Luminex Single Antigen bead assay, Immucor). For HLA typing, a polymerase chain reaction-sequence-specific oligonucleotide method was used that also included Luminex detection. RESULTS: In three RBC-associated TRALI cases, HLA Class I and II antibodies found in the patient's plasma were specific for the HLA type of the transfused leukoreduced blood product. In a fourth case, HLA antibodies were found in a patient who developed TRALI after repeated granulocyte infusions. The HLA antibodies were directed against HLA antigens present on the donor WBCs. CONCLUSION: The diagnosis of reverse TRALI was retained in four cases, suggesting that reverse TRALI is more frequent than described in the literature, especially in patients with an increased risk for having HLA antibodies.

Ten years of TRALI mitigation: measuring our progress.

BACKGROUND: Transfusion-related acute lung injury (TRALI) is a leading cause of transfusion-associated mortality for which multiple mitigation strategies have been implemented over the past decade. However, product-specific TRALI rates have not been reported longitudinally and may help refine additional mitigation strategies. STUDY DESIGN AND METHODS: This retrospective multicenter study included analysis of TRALI rates from 2007 through 2017. Numerators included definite or probable TRALI reports from five blood centers serving nine states in the United States. Denominators were components distributed from participating centers. Rates were calculated as per 100,000 components distributed (p < 0.05 significant). RESULTS: One hundred four TRALI cases were reported from 10,012,707 components distributed (TRALI rate of 1.04 per 100,000 components). The TRALI rate was 2.25 for female versus 1.08 for male donated components (p < .001). The TRALI rate declined from 2.88 in 2007 to 0.60 in 2017. From 2007 to 2013, there was a significantly higher TRALI rate associated with female versus male plasma (33.85 vs. 1.59; p < 0.001) and RBCs (1.97 vs. 1.15; p = 0.03). From 2014 through 2017, after implementation of mitigation strategies, a significantly higher TRALI rate only from female-donated plateletpheresis continued to be observed (2.98 vs. 0.75; p = 0.04). CONCLUSION: Although the TRALI rates have substantially decreased secondary to multiple strategies over the past decade, a residual risk remains, particularly with female-donated plateletpheresis products. Additional tools that may further mitigate TRALI incidence include the use of buffy coat pooled platelets suspended in male donor plasma or platelet additive solution due to the lower amounts of residual plasma.

Donor characteristics do not influence transfusion-related acute lung injury incidence in a secondary analysis of two case-control studies.

OBJECTIVE: To investigate the relation between donor characteristics and TRALI incidence. BACKGROUND: Transfusion-related acute lung injury (TRALI) is a potentially fatal complication of transfusion. In pre-clinical studies and several clinical studies, TRALI has been related to loss of product quality during red blood cell (RBC) storage, called the "storage lesion". Donor characteristics, as for example age, genetics and life style choices influence this "storage lesion". We hypothesized that donor sex, age and blood type is related to TRALI incidence. METHODS/MATERIALS: We performed a secondary analysis of two cohort studies, designed to identify TRALI risk factors by matching TRALI patients to transfused controls. We obtained donor sex, age and blood type from the Dutch Blood Bank Sanquin and investigated TRALI incidence in patients who were exposed to a certain donor characteristic. We used Kruskal-Wallis testing to compare the number of transfused products and Chi2 testing to compare proportions of TRALI patients and transfused control. RESULTS: After implementation of the male-donor only plasma strategy, patients received more transfusion products from male donors. However, we did not detect a relation between TRALI incidence and donor sex. Both TRALI patients and transfused controls received mainly products from donors over 41 years old, but donor age did not influence TRALI risk. Donor blood type, the transfusion of blood type-compatible and blood type-matched products also had no influence on TRALI incidence. CONCLUSION: We conclude that in two cohorts of TRALI patients, donor age, donor sex and donor blood type are unrelated to TRALI.

Incidence and Epidemiology of Perioperative Transfusion-Related Pulmonary Complications in Pediatric Noncardiac Surgical Patients: A Single-Center, 5-Year Experience.

BACKGROUND: Transfusion-related acute lung injury (TRALI) and transfusion-associated circulatory overload (TACO) are the leading causes of transfusion-related fatalities. While these transfusion-related pulmonary complications (TRPCs) have been well detailed in adults, their burden in pediatric subsets remains poorly defined. We sought to delineate the incidence and epidemiology of pediatric TRPCs after intraoperative blood product transfusion. METHODS: In this retrospective cohort study, we evaluated all consecutive pediatric patients receiving intraoperative blood product transfusions during noncardiac surgeries between January 2010 and December 2014. Exclusion criteria were cyanotic heart disease, preoperative respiratory insufficiency, extracorporeal membrane oxygenation, and American Society of Anesthesiologists physical status VI. Medical records were electronically screened to identify those with evidence of hypoxemia, and in whom a chest x-ray was obtained within 24 hours of surgery. Records were then manually reviewed by 2 physicians to determine whether they met diagnostic criteria for TACO or TRALI. Disagreements were adjudicated by a third senior physician. RESULTS: Of 19,288 unique pediatric surgical patients, 411 were eligible for inclusion. The incidence of TRPCs was 3.6% (95% confidence interval [CI], 2.2-5.9). TACO occurred in 3.4% (95% CI, 2.0-5.6) of patients, TRALI was identified in 1.2% (95% CI, 0.5-2.8), and 1.0% (95% CI, 0.4-2.5) had evidence for both TRALI and TACO. Incidence was not different between males (3.4%) and females (3.8%; P = .815). Although a trend toward an increased incidence of TRPCs was observed in younger patients, this did not reach statistical significance (P = .109). Incidence was comparable across subsets of transfusion volume (P = .184) and surgical specialties (P = .088). Among the 15 patients experiencing TRPCs, red blood cells were administered to 13 subjects, plasma to 3, platelets to 3, cryoprecipitate to 2, and autologous blood to 3. Three patients with TRCPs were transfused mixed blood components. CONCLUSIONS: TRPCs occurred in 3.6% of transfused pediatric surgical patients, with the majority of cases attributable to TACO, congruent with adult literature. The frequency of TRPCs was comparable between genders and across surgical procedures and transfusion volumes. The observed trend toward increased TRPCs in younger children warrants further consideration in future investigations. Red blood cell administration was the associated component for the majority of TRPCs, although platelets demonstrated the highest risk per component transfused. Mitigation of perioperative risk associated with TRPCs in pediatric patients is reliant on further multiinstitutional studies powered to examine patterns and predictors of this highly morbid entity.