Adverse events caused by cord blood infusion in Japan during a 5-year period.

BACKGROUND AND OBJECTIVES: In Japan, cord blood is used for more than half of all unrelated stem cell transplantations. The public cord blood banks (CBBs) have been collecting information on cord blood transplantation-related adverse events from physicians on a voluntary basis, without common definitions of the adverse reactions. The aims of this study were to compare two classification systems to improve the reporting system and to clarify the actual risk from cord blood infusion, which can then provide the impetus to take appropriate measures to reduce adverse events. MATERIALS AND METHODS: We classified the reports according to existing criteria; one is the Proposed Standard Definitions for Surveillance of Non-Infectious Adverse Transfusion Reactions by the International Society of Blood Transfusion (ISBT) Working Party on Haemovigilance, and the other is the Common Terminology Criteria for Adverse Events (CTCAE). There were 140 cases with adverse events reported from April 2014 through March 2019. RESULTS: Twelve cases, such as donor-derived leukaemia/myelodysplastic syndromes (MDS) and chromosomal aberrations reported after engraftment, were excluded from this analysis. Of the 128 cases with adverse events at cord blood infusion, the CTCAE and ISBT criteria could not classify 6 cases and 68 cases, respectively. Classifying by the CTCAE, the most common side effect was hypertension in 35 cases, followed by anaphylaxis, allergic reactions, nausea, urticaria, etc. Serious adverse events (grades 4 and 5) were mainly anaphylaxis, with a frequency of 0.23%. CONCLUSION: It is necessary not only to provide information on adverse events but also to standardize the reporting of adverse events to support measures to reduce them.

Facing difficult but unavoidable choices: Donor blood safety and the deferral of men who have sex with men.

Blood service organizations employ various ways to ensure transfusion blood safety, including the testing of all donations for transfusion-transmissible infections (TTI) and the exclusion of donors who are at increased risk of a recent infection. As some TTIs are more common among men who have sex with men (MSM), many jurisdictions (temporarily) defer the donation of blood by sexually active MSM. This boils down to a categorical exclusion of a large group solely on the basis of their sexual orientation, which is seen as unduly discriminatory and stigmatizing. Blood service organizations in the U.K. and the Netherlands have recently changed their deferral policies for MSM. The problem of the MSM deferral involves a conflict between fundamental rights: the right of MSM to equal treatment and the right to health of the recipients of blood and blood products. We distinguish and discuss three broad alternative options to the current categorical deferral of MSM donations: (1) completely abandoning donor selection on the basis of sexual behavior, (2) individual risk assessment of the sexual activities of each potential donor, and (3) individual risk assessment of the sexual activities of MSM only. The new U.K. policy falls within the second category, and the new Dutch policy is in the third category. We argue that each approach comes with moral costs but that the most reasonable option is different from the policies of both the U.K. and the Netherlands.

Development of the Chinese Haemovigilance Network and reporting of adverse transfusion reactions from 2018 to 2020.

BACKGROUND AND OBJECTIVES: To advance blood transfusion safety, the Chinese Haemovigilance Network (CHN) was put into operation in 2018. This report describes the development of the CHN and evaluates its role by analysing reported adverse transfusion reactions (ATRs) from 2018 to 2020. MATERIALS AND METHODS: All data in this study were obtained from the CHN online reporting platform. A timeline of CHN development is presented, and the activities of CHN-enrolled facilities are analysed by year. The reported ATRs were analysed in detail for ATR types, blood components involved and adherence to case definition, severity and imputability criteria. Incidence rates were calculated and compared with international examples. RESULTS: During 2018-2020, a total of 3061 ATRs were reported through the CHN online reporting system. The rate of reported ATRs in all facilities and the 10 highest reporting facilities was 0.7‰ and 1.8‰, respectively. When analysed by year, the incidence rate showed an increasing trend from 2018 to 2020. Allergic (68.2%) and febrile non-haemolytic transfusion reaction (27.1%) were the most common. The vast majority of ATRs (92.0%) were not serious, but serious cases of transfusion-associated circulatory overload, transfusion-associated dyspnoea and hypotensive reaction were common. Most (86.0%) of reported cases were definitely or probably associated with transfusion. CONCLUSION: Under-reporting of ATRs occurs in many Chinese hospitals, but the establishment of CHN has increased ATR recognition and management. More effort will be needed in the future to detect transfusion problems and improve transfusion practice in China.

Transfusion double whammy? Adrenaline-takotsubo-anaphylaxis-Kounis complex post transfusion?

BACKGROUND AND OBJECTIVES: The adrenaline-takotsubo-anaphylaxis-Kounis, or the ATAK complex, where there are clinical and pathophysiological overlaps between takotsubo and Kounis syndromes, in which histaminergic, adrenergic and other mediators may play roles, was recently described. The objective of this report was to describe three cases where the ATAK complex was suspected to have occurred after transfusion. MATERIALS AND METHODS: Three cases were recently reported to the New Zealand Blood Service haemovigilance programme that appeared to have features in common suggestive of the ATAK complex. RESULTS: All three patients had had a blood component transfused, an initial severe allergic reaction, treatment with adrenaline or a congener, subsequent acute left ventricular failure or transfusion-associated circulatory overload, and features suggestive of takotsubo cardiomyopathy. CONCLUSIONS: Although rarely described, transfusion-associated ATAK complex may be occurring more often than believed. Circumstances during a transfusion may predispose to it. It should be suspected if the sequence of events described above occur. Its characteristics need to be better understood. Risk factors for it may be modifiable.

Hepatitis B infections among blood donors in England between 2009 and 2018: Is an occult hepatitis B infection a risk for blood safety?

INTRODUCTION: Hepatitis B virus (HBV) is one of the most frequent infections identified in blood donors in England and represents an ongoing blood safety risk. We have analyzed markers of HBV infections in blood donors in England between 2009 and 2018 and used these to estimate the likelihood of non-detection of occult HBV infection (OBI). METHODS: We collected epidemiological, virological, and genotyping information on HBV cases identified in England, 2009-2018. The estimated risk of non-detection and likely transmission of OBI were compared to lookback and transfusion-transmitted infections surveillance data. RESULTS: Six-hundered and fifty-five HBV-infected blood donors were identified in England during the 10-year period; 598 chronic, 32 acute, and 25 occult HBV infections. However, most donors with chronic and occult infections were born in Eastern Europe, Africa, or Asia (451/544, 83% and 14/24, 58%); acute infections were largely seen in UK-born donors (19/28, 68%). Genotyping of 266 HBV-positive samples revealed five genotypes (A-E), reflecting ethnicity and country of birth. Most OBIs were identified in repeat donors (19/25); lookback data identified a transmission rate of 8.3%. It is estimated that at least 13 potentially infectious donations from donors with OBI remain undetected annually, equating to an overall residual transmission risk of 3.1 per million donations using our current screening strategy of HBsAg screening with HBV nucleic acid testing (NAT) in pools of 24. CONCLUSIONS: OBI accounted for the majority of the HBV residual risk in England. Further cost-benefit analysis is required to estimate if our current HBV screening strategy should be changed.

The impact of delayed and immediate adverse events on the intention of future donations in whole blood and plateletpheresis donors.

BACKGROUND: Adverse donor events (ADEs) are usually mild and short-term with no sequelae, but may cause disinclination toward future donations. AIMS: To determine the impact of delayed ADEs (D-ADEs) in addition to immediate ADEs (I-ADEs) on the intention of future donations (IFDs) and to analyze the various associated factors. METHODS: ADEs were categorized following the ISBT working group on donor vigilance. Telephonic interviews of the donors were conducted 2 weeks after the whole blood (WB) and plateletpheresis donation to inquire about D-ADEs and IFDs. RESULTS: A total of 3514 WB and 531 plateletpheresis donors were included in the study. WB donors had an overall higher IFD as compared to plateletpheresis donors (89.53% vs 57.06%, P < .001). A higher IFD was observed in male WB donors as compared to female WB donors (89.95% vs 75%, P < .001). Repeat WB donors had a higher IFD as compared with first-time donors (93.66% vs 81.37%, P < .001). A total of 13.7% WB donors and 19.2% plateletpheresis donors reported D-ADEs. WB donors who experienced D-ADEs had a significantly lower IFD (78.38% vs 91.63%, P < .001) as compared with donors without any ADEs; a similar trend was observed in donors who experienced I-ADEs (69.90% vs 91.63%, P < .001). In WB donors, systemic D-ADEs such as fatigue had a more negative impact on IFDs as compared with localized D-ADEs such as bruises (63.93% vs 86.83%, P < .001). CONCLUSIONS: Both D-ADEs and I-ADEs negatively impact donors' intention to donate again. Systemic D-ADEs had a more negative impact on IFDs as compared with localized D-ADEs.

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.

COVID-19 pandemic and transfusion medicine: the worldwide challenge and its implications.

COVID-19 pandemic has imposed worldwide challenge and has significantly affected transfusion medicine. Shortage in blood products along with concerns regarding the safety of blood products have emerged. Measures to overcome these challenges have been implemented in order to decrease the demand on blood products and to encourage blood donations while taking full precautions to minimize risk of COVID-19 transmission mainly at blood banks and medical centers. Several countries have been successful in facing these new challenges. In addition, the role of plasma therapy in the treatment of COVID-19 patients, especially in severe cases, has been proposed and current studies are being conducted to determine its efficacy. Other therapeutic options are currently being explored. So far, the use of convalescent plasma is considered a promising rescue treatment to be looked at.

Human babesiosis: recent advances and future challenges.

PURPOSE OF REVIEW: As human babesiosis caused by apicomplexan parasites of the Babesia genus is associated with transfusion-transmitted illness and relapsing disease in immunosuppressed populations, it is important to report novel findings relating to parasite biology that may be responsible for such pathology. Blood screening tools recently licensed by the FDA are also described to allow understanding of their impact on keeping the blood supply well tolerated. RECENT FINDINGS: Reports of tick-borne cases within new geographical regions such as the Pacific Northwest of the USA, through Eastern Europe and into China are also on the rise. Novel features of the parasite lifecycle that underlie the basis of parasite persistence have recently been characterized. These merit consideration in deployment of both detection, treatment and mitigation tools such as pathogen inactivation technology. The impact of new blood donor screening tests in reducing transfusion transmitted babesiosis is discussed. SUMMARY: New Babesia species have been identified globally, suggesting that the epidemiology of this disease is rapidly changing, making it clear that human babesiosis is a serious public health concern that requires close monitoring and effective intervention measures. Unlike other erythrocytic parasites, Babesia exploits unconventional lifecycle strategies that permit host cycles of different lengths to ensure survival in hostile environments. With the licensure of new blood screening tests, incidence of transfusion transmission babesiosis has decreased.

Prevalence of natural and acquired antibodies to amustaline/glutathione pathogen reduced red blood cells.

BACKGROUND: The INTERCEPT™ Blood System for Red Blood Cells (RBCs) utilizes amustaline (S-303) and glutathione (GSH) to inactivate pathogens and leukocytes in transfused RBCs. Treatment-emergent low titer non-hemolytic antibodies to amustaline/GSH RBC were detected in clinical trials using a prior version of the process. The amustaline/GSH process was re-formulated to decrease S-303 RBC adduct formation. STUDY DESIGN AND METHODS: A standard three-cell antibody screening panel was modified to include reagent red cells (RRC) with high (S-303H) or low (S-303L) S-303 adduct density as assessed by flow cytometry, representative of the original and current amustaline/GSH treatment processes, respectively. General hospital and RBC transfusion-dependent patients never exposed, and clinical trial subjects exposed to amustaline/GSH RBC were screened for antibodies to amustaline/GSH RBC using a standardized agglutination assay. RESULTS: Twelve (0.1%) of 10,721 general hospital and 5 (0.5%) of 998 repeatedly-transfused patients not previously exposed to amustaline/GSH RBCs expressed natural, low titer (2-32) IgM and/or IgG (non-IgG1 or IgG3 isotype) antibodies with acridine (a structural element of amustaline) (n = 14) or non-acridine (n = 3) specificity. 11 of 17 sera reacted with S-303L panel RRCs. In clinical studies 81 thalassemia and 25 cardiac surgery patients were transfused with a total of 1085 amustaline/GSH RBCs and no natural or treatment-emergent S-303 antibodies were detected. CONCLUSION: Standardized RRC screening panels are sensitive for the detection of natural and acquired S-303-specific antibodies. Natural low titer antibodies to amustaline/GSH RBC are present in 0.15% of naïve patients. The clinical relevance of these antibodies appears minimal but is under further investigation.

Bacterial contamination and septic transfusion reaction rates associated with platelet components before and after introduction of primary culture: experience at a US Academic Medical Center 1991 through 2017.

BACKGROUND: The high incidence of septic transfusion reactions (STRs) led to testing being mandated by AABB from 2004. This was implemented by primary culture of single-donor apheresis platelets (APs) from 2004 and prestorage pooled platelets (PSPPs) from 2007. STUDY DESIGN/METHODS: Platelet (PLT) aliquots were cultured at issue and transfusion reactions evaluated at our hospital. Bacterial contamination and STR rates (shown as rates per million transfusions in Results) were evaluated before and after introduction of primary culture by blood centers that used a microbial detection system (BacT/ALERT, bioMerieux) or enhanced bacterial detection system (eBDS, Haemonetics). RESULTS: A total of 28,457 PLTs were cultured during pre-primary culture periods (44.7% APs; 55.3% at-issue pooled PLTs [AIPPs]) and 97,595 during post-primary culture periods (79.3% APs; 20.7% PSPPs). Forty-three contaminated units were identified in preculture and 34 in postculture periods (rates, 1511 vs. 348; p < 0.0001). Contamination rates of APs were significantly lower than AIPPs in the preculture (393 vs. 2415; p < 0.0001) but not postculture period compared to PSPPs (387 vs. 198; p = 0.9). STR rates (79 vs. 90; p = 0.98) were unchanged with APs but decreased considerably with pooled PLTs (826 vs. 50; p = 0.0006). Contamination (299 vs. 324; p = 0.84) and STR rates (25 vs. 116; p = 0.22) were similar for PLTs tested by BacT/ALERT and eBDS primary culture methods. A change in donor skin preparation method in 2012 was associated with decreased contamination and STR rates. CONCLUSION: Primary culture significantly reduced bacterial contamination and STR associated with pooled but not AP PLTs. Measures such as secondary testing near time of use or pathogen reduction are needed to further reduce STRs.

Influence of sickle cell disease on susceptibility to HIV infection.

People with sickle cell disease (SCD) are reported to have low rates of HIV infection, slower progression to AIDS and lower HIV-associated mortality compared to the general population. Mechanisms of potential resistance to HIV in SCD are incompletely understood. We retrospectively reviewed the Transfusion Safety Study to compare HIV status between people with SCD and other congenital anemias who were routinely exposed to blood products during the high-risk period before HIV screening implementation. Non-SCD congenital anemia diagnosis was associated with a higher risk of HIV acquisition compared to SCD (OR 13.1 95%CI 1.6-108.9). In addition, we prospectively enrolled 30 SCD cases and 30 non-SCD controls to investigate potential mechanisms of resistance to HIV in SCD. CCR5 and CCR7 expression was lower and CD4 expression was higher on CD4+ T cells from SCD cases compared to controls. Surface expression of CD4+ T cell CXCR4, CD38 and HLA-DR did not differ between the groups. SCD CD4+ T cells were not less susceptible to HIV infection than controls. Levels of multiple cytokines were elevated in the SCD plasma, but SCD plasma compared to control plasma did not inhibit HIV infection of target cells. In conclusion, our epidemiological data support people with SCD being resistant to HIV infection. Potential mechanisms include lower CD4+ T cell expression of CCR5 and CCR7, balanced by increased CD4 expression and cytokine levels, which did not result in in vitro resistance to HIV infection. Further study is needed to define the risk and pathophysiology of HIV in persons with SCD.

Implementation of a patient blood management program in hematopoietic stem cell transplantation (Editorial, p. 2763).

BACKGROUND: Recipients of hematopoietic stem cell transplantation (HSCT) are among the highest consumers of allogeneic red blood cell (RBC) and platelet (PLT) components. The impact of patient blood management (PBM) efforts on HSCT recipients is poorly understood. STUDY DESIGN AND METHODS: This observational study assessed changes in blood product use and patient-centered outcomes before and after implementing a multidisciplinary PBM program for patients undergoing HSCT at a large academic medical center. The pre-PBM cohort was treated from January 1 through September 31, 2013; the post-PBM cohort was treated from January 1 through September 31, 2015. RESULTS: We identified 708 patients; 284 of 352 (80.7%) in the pre-PBM group and 225 of 356 (63.2%) in the post-PBM group received allogeneic RBCs (p < 0.001). Median (interquartile range [IQR]) RBC volumes were higher before PBM than after PBM (3 [2-4] units vs. 2 [1-4] units; p = 0.004). A total of 259 of 284 pre-PBM patients (91.2%) and 57 of 225 (25.3%) post-PBM patients received RBC transfusions when hemoglobin levels were more than 7 g/dL (p < 0.001). The median (IQR) PLT transfusion quantities was 3 (2-5) units for pre-PBM patients and 2 (1-4) units for post-PBM patients (p < 0.001). For patients with PLT counts of more than 10 × 109 /L, a total of 1219 PLT units (73.4%) were transfused before PBM and 691 units (48.8%) were transfused after PBM (p < 0.001). Estimated transfusion expenditures were reduced by $617,152 (18.3%). We noted no differences in clinical outcomes or transfusion-related adverse events. CONCLUSION: Patient blood management implementation for HSCT recipients was associated with marked reductions in allogeneic RBC and PLT transfusions and decreased transfusion-related costs with no detrimental impact on clinical outcomes.

Is there a risk of transfusion-transmissible infections after percutaneous needle treatments in blood donors? A systematic review and meta-analysis.

BACKGROUND AND OBJECTIVES: The donor medical questionnaire identifies a blood donor's history of known blood safety risks. Current Australian, Canadian, European and USA legislation temporarily defers blood donors who received different percutaneous needle treatments (i.e. tattooing, acupuncture and piercing) from blood donation. This systematic review aimed to scientifically underpin these deferrals by identifying the best available evidence on the association between percutaneous needle treatments and the risk of transfusion-transmissible infections (TTIs). MATERIALS AND METHODS: Studies from three databases investigating the link between percutaneous needle treatments and TTIs (HBV, HCV and HIV infection) in blood donors were retained and assessed on eligibility by two reviewers independently. The association between percutaneous needle treatments and TTIs was expressed by conducting meta-analyses and calculating pooled effect measures (odds ratios (ORs) and 95% CIs). The GRADE methodology (Grades of Recommendation, Assessment, Development and Evaluation) was used to assess the quality of evidence. RESULTS: We identified 1242 references and finally included 21 observational studies. Twenty studies assessed the link between percutaneous needle treatments and HCV infection and found that blood donors receiving these treatments had an increased risk of HCV infection (tattooing: pooled OR 5·28, 95% CI [4·33, 6·44], P < 0·00001 (low-quality evidence); acupuncture: pooled OR 1·56, 95% CI [1·17, 2·08], P = 0·03 (very low-quality evidence); and piercing: pooled OR 3·25, 95% CI [1·68, 6·30], P = 0·0005 (low-quality evidence)). CONCLUSION: Percutaneous needle treatments may be associated with an increased HCV infection risk. Further high-quality studies are required to formulate stronger evidence-based recommendations on percutaneous needle treatments as a blood donor deferral criterion.

Frequência das reações transfusionais imediatas ocorridas em hospital de ensino em São Paulo, Brasil / The frequency of immediate transfusions reactions occurred in a teaching hospital from Sao Paulo, Brazil / La frecuencia de las Reacciones transfusionales inmediatas ocurridas en hospital de enseñanza en Sao Paulo, Brasil

Objetivo: descrever a ocorrência das reações transfusionais imediatas recebidas na Gerência de Risco do Hospital São Paulo. Metodologia: foi realizado um estudo transversal retrospectivo, com analises das fichas de notificação de Reações Transfusionais no período de maio de 2002 a dezembro de 2016 que foram inseridas no SNH. Resultados: foram analisadas 1548 fichas de RT, em sua quase totalidade reações imediatas, associadas ao Concentrado de Hemácias (72,5%). A mais comum foi a Reação Febril Não Hemolítica leve, sendo entre as graves e moderadas a Reação Alérgica. Os sinais e sintomas mais notificados foram a hipertermia, a sudorese, calafrios e lesões em derme. Não foram observadas diferenças entre sexo e idade, 90,8% das Reações Transfusionais ocorreram em pacientes com Fator Rh(+). Conclusão: o estudo permitiu uma melhor avalição e compreensão das reações transfusionais o que permite maior qualidade no ciclo do sangue e uma maior segurança dos pacientes submetidos a terapia transfusional.

Objective: to describe the occurrence of the immediate transfusion reactions received at the Risk Management of Hospital São Paulo. Methodology: a cross-sectional retrospective study was carried out, with analyzes of the ATR (Adverse Transfusional Reactions) in the period from May 2002 to December 2016 which were inserted in the National Haemovigilance System (SNH). Results: it were analyzed 1548 ATR records, most of which were immediate reactions, associated with the Red blood cells Concentrate (72,5%). The most common slight reaction was FNHTR (Febrile non-hemolytic transfusion reaction), and being between severe and moderate reactions, The Allergic reaction. The most commonly reported signs and symptoms were hyperthermia, sweating, chills and skins lesions. No differences were observed between gender and age, 90.8% of ATR occurred in patients with RhD positive blood group. Conclusion: the study allowed a better evaluation and understanding of the transfusion reactions which allowed higher quality in the blood cycle and increased safety of patients undergoing transfusion therapy.

Objetivo: describir la ocurrencia de las reacciones transfusionales inmediatas recibidas en la Gestión de Riesgo del Hospital São Paulo. Metodología: se realizó un estudio transversal retrospectivo, con análisis de las fichas de notificación de Reacciones Transfusionales en el período de mayo de 2002 a diciembre de 2016 que fueron introducidas en el SNH. Resultados: se analizaron 1548 fichas de RT inmediatas, asociadas al Concentrado de Hemácias (72,5%). La más común fue la Reacción Febril no Hemolítica leve, siendo la reacción alérgica entre las graves y moderadas. Los signos y síntomas más notificados fueron la fiebre, la sudoración, escalofríos y lesiones en dermis. No se observaron diferencias entre sexo y edad, el 90,8% de las Reacciones Transfusionales ocurrieron en pacientes con Factor Rh(+). Conclusión: el estudio permitió una mejor evaluación y comprensión de las reacciones transfusionales, lo que permite mayor calidad en el ciclo de la sangre y una mayor seguridad de los pacientes sometidos a terapia transfusional.

Lead and Mercury Levels in Preterm Infants Before and After Blood Transfusions.

Very low birth weight (VLBW) infants usually receive packed red blood cell unit (pRBC) transfusions. Heavy metal transfer via pRBCs is not widely discussed before. This study aimed to determine pre-/post-transfusion erythrocyte lead and mercury levels in infants and to correlate these levels to heavy metal concentrations in pRBCs. VLBW infants (n = 80), needing pRBC transfusion for the first time, were enrolled. Erythrocyte heavy metal levels were determined in pre-/post-transfusion blood samples and also in pRBC units. Mean lead and mercury levels in the pRBCs were found to be 16.3 ± 10.8 and 3.75 ± 3.23 µg/L, respectively. Of the infants, 69.7% received lead above reference dose. Erythrocyte lead levels increased significantly after transfusions (10.6 ± 10.3 vs. 13 ± 8.5, p < 0.05) with significant correlated to amount of lead within pRBCs (r = 0.28). Mean pre-/post-transfusion erythrocyte mercury levels were 3.28 ± 3.08 and 3.5 ± 2.83 µg/L, respectively (p > 0.05). There was a significant correlation between mean difference of mercury levels after transfusion and amount of mercury delivered by pRBCs (r = 0.28). Infants can be subject to high levels of lead and mercury through pRBC transfusions.

Hemovigilancia de los efectos adversos a la donación de sangre / Hemovigilance of side effects related to blood donation

La donación de sangre es el sustento de los programas que proporcionan la sangre segura para el uso terapéutico, con el fin de preservar la salud y vida humana. Es necesario prestar especial atención a la seguridad y calidad de esta actividad ya que es también un principio ético, cuidar de la salud del que de forma altruista da parte de si para beneficiar a los demás. Aunque la donación es un proceder seguro, en ocasiones pueden presentarse efectos adversos en los donantes, algunos evitables, que pueden repercutir en su salud o afectar el retorno a esta actividad. A inicios de la década de 1990, surgen los programas de hemovigilancia encargados de velar, notificar, investigar y prevenir los efectos adversos de la transfusión y la donación, con el fin de prevenir su recurrencia e incrementar la seguridad y calidad de ambos procederes. Este trabajo realiza una revisión actualizada sobre las reacciones adversas de la donación en el contexto de la hemovigilancia(AU)

Blood donation is the livelihood of all blood programs to provide safe blood transfusion for therapeutic use whit the aim to preserve health and human life. It is necessary to pay attention to the safety and quality of this activity, because is an ethical principle to take care of the health of those who, in an altruist manner, give part of themselves in order to benefit others. Although the donation is a safe procedure, occasionally some side effects in donors may occur, many of them can be avoided, and that could have an echo on the donors' health on effect their return to this activity. At the beginning of the 90ths, decade started the Hemovigilance programs in charge of the vigilance, notification and prevention of transfusion and donation side effects, whit the purpose of preventing its recurrence and increase the safety and quality of both procedures. This work carries out and update revision about of donor's reactions in the Hemovigilance(AU)

Transfusion-related sepsis: a silent epidemic.

In this issue of Blood, Hong et al advocate for use of additional US Food and Drug Administration (FDA)­approved safety measures for transfusion. Most patients transfused with contaminated platelets do not show immediate clinical signs. Active surveillance suggests patient risk 10- to 40-fold higher than passive hemovigilance.

Detection of septic transfusion reactions to platelet transfusions by active and passive surveillance.

Septic transfusion reactions (STRs) resulting from transfusion of bacterially contaminated platelets are a major hazard of platelet transfusion despite recent interventions. Active and passive surveillance for bacterially contaminated platelets was performed over 7 years (2007-2013) by culture of platelet aliquots at time of transfusion and review of reported transfusion reactions. All platelet units had been cultured 24 hours after collection and released as negative. Five sets of STR criteria were evaluated, including recent AABB criteria; sensitivity and specificity of these criteria, as well as detection by active and passive surveillance, were determined. Twenty of 51,440 platelet units transfused (0.004%; 389 per million) were bacterially contaminated by active surveillance and resulted in 5 STRs occurring 9 to 24 hours posttransfusion; none of these STRs had been reported by passive surveillance. STR occurred only in neutropenic patients transfused with high bacterial loads. A total of 284 transfusion reactions (0.55%) were reported by passive surveillance. None of these patients had received contaminated platelets. However, 6 to 93 (2.1%-32.7%) of these 284 reactions met 1 or more STR criteria, and sensitivity of STR criteria varied from 5.1% to 45.5%. These results document the continued occurrence of bacterial contamination of platelets resulting in STR in neutropenic patients, failure of passive surveillance to detect STR, and lack of specificity of STR criteria. These findings highlight the limitations of reported national STR data based on passive surveillance and the need to implement further measures to address this problem such as secondary testing or use of pathogen reduction technologies.

Effects of riboflavin and amotosalen photoactivation systems for pathogen inactivation of fresh-frozen plasma on fibrin clot structure.

BACKGROUND: Fresh-frozen plasma (FFP) transfusion carries a risk of viral transmission from donor to recipient. Riboflavin (Mirasol) and amotosalen (Intercept) are two pathogen inactivation (PI) methods that may enhance the safety of FFP for transfusion. Our study investigated the effects of Mirasol and Intercept treatment on fibrin formation and clot structure. STUDY DESIGN AND METHODS: FFP underwent either Mirasol or Intercept treatment, and aliquots were taken before addition of the compound, before illumination (after addition of compound only), and after treatment (addition of compound plus illumination). All samples underwent turbidimetric analysis, lysis analysis, assessment of clot permeation, and analysis by laser scanning confocal microscopy. RESULTS: After treatment, there was a decrease in optical density of the fibrin network for Mirasol and Intercept, lag time to fibrin formation was prolonged for Mirasol and lysis time for Intercept, clot permeability was significantly decreased, and clot density was increased for both. CONCLUSIONS: Our study shows that plasma treated with Mirasol and Intercept produces denser clots consisting of thinner fibers and warrants further studies to evaluate the clinical significance of these structural changes in fibrin clot formation.