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1.
Lab Med ; 55(3): 251-254, 2024 May 02.
Artigo em Inglês | MEDLINE | ID: mdl-38175635

RESUMO

BACKGROUND: Due to chemotherapy-induced neutropenia or hematologic malignancies, immunocompromised cancer patients may have higher incidence of febrile nonhemolytic transfusion reactions compared with the general population and frequently require platelet transfusions. This quality improvement project compared the safety of transfusion using prestorage leukocyte-reduced and pooled whole blood-derived platelets (Acrodose/WBD) with conventionally produced poststorage WBD platelets (RDP) using an active hemovigilance system. METHODS: Every patient receiving a blood product at the hospital was virtually monitored in real time by trained nurses from a remote hemovigilance unit. These nurses monitor a digital dashboard, which populates a watch list of patients from the time blood product administration is initiated until 12 hours posttransfusion. Over the course of 6 months, 371 patients receiving 792 RDP transfusions and 423 patients receiving 780 Acrodose/WBD platelets transfusions were monitored for transfusion reactions. RESULTS: We identified 26 transfusion reactions in RDP but only 12 transfusion reactions in the Acrodose/WBD platelet group. CONCLUSION: Acrodose platelet transfusion was associated with fewer transfusion reactions, which resulted in significant cost savings.


Assuntos
Redução de Custos , Transfusão de Plaquetas , Humanos , Transfusão de Plaquetas/efeitos adversos , Transfusão de Plaquetas/métodos , Transfusão de Plaquetas/economia , Masculino , Feminino , Pessoa de Meia-Idade , Reação Transfusional/prevenção & controle , Idoso , Segurança do Sangue/métodos , Segurança do Sangue/economia , Adulto , Procedimentos de Redução de Leucócitos/métodos
2.
Transfusion ; 63(12): 2273-2280, 2023 12.
Artigo em Inglês | MEDLINE | ID: mdl-37909172

RESUMO

INTRODUCTION: In 2018, platelet (PLT) additive solution-E (PAS-E) was introduced. The implementation of PAS-E was expected to diminish the number of allergic reactions in recipients following a PLT transfusion. Here, we evaluated the efficacy and safety of transfusions with PLTs stored in PAS-E. STUDY DESIGN AND METHODS: After implementation of PAS-E, data were collected from 2 cohorts of patients with hematological disorders as well as oncology patients, receiving PLTs in PAS-E. A similar patient group in a recent RCT, receiving PLTs in plasma, was used as a historical control group for both cohorts. Endpoints were corrected count increments (CCIs), bleeding scores (only reported in cohort 1), and the incidence of adverse reactions. RESULTS: In cohort 1, the mean 1-h CCI was 14.3 ± 6.9, and the 24-h CCI was 8.7 ± 5.6. In cohort 2, the 1-h CCI was 11.6 ± 7.8 and the 24-h CCI was 7.0 ± 6.1. In the control group, the 1-h CCI was 15.4 ± 5.5 and 24-h CCI 8.7 ± 4.8. Bleeding complications of WHO grade ≥2 occurred in 40% of patients in cohort 1 compared to 44% in plasma PCs. The incidence of adverse reactions was 1.2% in the two PAS-E cohorts, compared to 3.0% in plasma PCs. National hemovigilance data showed a significant reduction in allergic reactions with PAS-E PC transfusions as compared to plasma PCs with an odds ratio of 0.46 (CI 95% 0.37-0.58). CONCLUSION: The CCIs of PLTs in PAS-E were decreased compared to plasma PCs, but clinically acceptable. Allergic transfusion reactions were decreased in PAS-E PCs compared to plasma PCs.


Assuntos
Hipersensibilidade , Reação Transfusional , Humanos , Plaquetas , Transfusão de Plaquetas/efeitos adversos , Segurança do Sangue , Reação Transfusional/etiologia , Preservação de Sangue , Hipersensibilidade/etiologia
3.
Vox Sang ; 118(7): 533-542, 2023 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-37246454

RESUMO

BACKGROUND AND OBJECTIVES: Polyvinyl chloride (PVC) plasticized with di(2-ethylhexyl) phthalate (DEHP) is a widely used material for medical transfusion devices. Not covalently bound to PVC, DEHP can migrate into blood products during storage. Recognized as an endocrine disruptor and raising concerns about its potential carcinogenicity and reprotoxicity, DEHP is gradually being withdrawn from the medical device market. Therefore, the use of alternative plasticizers, such as diisononylcyclohexane-1,2-dicarboxylate (DINCH) and di(2-ethylhexyl) terephthalate (DEHT), as potential candidates for the replacement of DEHP in medical transfusion devices has been investigated. The purpose of this study was to evaluate the quantity of PVC-plasticizers in the blood components according to their preparation, storage conditions and in function of the plasticizer. MATERIALS AND METHODS: Whole blood was collected, and labile blood products (LBPs) were prepared by the buffy-coat method with a PVC blood bag plasticized either with DEHP, DINCH or DEHT. DINCH and DEHT equivalent concentrations were quantified in LBPs by liquid chromatography-tandem mass spectrometry or coupled with UV and compared to DEHP equivalent concentrations. RESULTS: The plasticizer equivalent concentration to which a patient is exposed during a transfusion depends on the preparation of LBPs as well as their storage conditions, that is, temperature and storage time. At day 1, for all LBPs, the migration of DEHP is 5.0 and 8.5 times greater than DINCH and DEHT, respectively. At the end of the 49 days storage period, the DEHP equivalent concentration in red blood cells concentrate is statistically higher when compared to DINCH and DEHT, with maximal values of 1.85, 1.13 and 0.86 µg/dm2 /mL, respectively. CONCLUSION: In addition to lower toxicity, transfused patients using PVC-DEHT or PVC-DINCH blood bags are less exposed to plasticizers than using PVC-DEHP bags with a ranging exposure reduction from 38.9% to 87.3%, due to lower leachability into blood components.


Assuntos
Preservação de Sangue , Ácidos Cicloexanocarboxílicos , Dietilexilftalato , Ácidos Ftálicos , Plastificantes , Humanos , Dietilexilftalato/análise , Plastificantes/análise , Cloreto de Polivinila/química , Preservação de Sangue/instrumentação , Preservação de Sangue/normas , Segurança do Sangue , Transfusão de Sangue/instrumentação , Transfusão de Sangue/normas , Ácidos Cicloexanocarboxílicos/análise , Cromatografia Líquida de Alta Pressão
4.
Vox Sang ; 118(1): 84-92, 2023 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-36454585

RESUMO

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.


Assuntos
Anafilaxia , Humanos , Japão , Sangue Fetal , Segurança do Sangue/efeitos adversos , Transfusão de Sangue
5.
Rev. enferm. UFSM ; 13: 17, 2023.
Artigo em Inglês, Espanhol, Português | LILACS, BDENF | ID: biblio-1428832

RESUMO

Objetivo: identificar os indicadores relacionados ao processo transfusional. Método: revisão integrativa de literatura realizada entre março e maio de 2022, em nove fontes de informação no período de 2001 a 2021. Como estratégia de busca, utilizaram-se os descritores "Indicadores de Qualidade em Assistência à Saúde", "Indicadores de Serviços", "Indicadores Básicos de Saúde", "Serviço de Hemoterapia", "Transfusão de Sangue", "Segurança do Sangue", com os operadores boleanos "AND" e "OR" em três idiomas, sendo analisados 49 artigos. Resultados: foram identificados 53 indicadores, os quais se agruparam para: gestão do estoque de hemocomponentes, de produção do processo transfusional, para avaliação do processo transfusional e de suporte do processo transfusional. Conclusão: os indicadores identificados possibilitam avaliação do processo transfusional, apesar de atividades, como a avaliação do cuidado, apresentarem poucos indicadores, evidenciando a necessidade de estudos sobre a temática e construção de novos indicadores para dar sustentação à avaliação mais aprimorada do processo transfusional.


Objective: to identify transfusion-related indicators. Method: an integrative literature review carried out between March and May 2022, in nine sources of information from 2001 to 2021. As a search strategy, the descriptors "Quality Indicators in Health Care", "Service Indicators", "Basic Health Indicators", "Hemotherapy Service", "Blood Transfusion", "Blood Safety" were used, with Boolean operators "AND" and "OR" in three languages, with 49 articles being analyzed. Results: a total of 53 indicators were identified, which were grouped for: blood component stock management, transfusion process production, transfusion process assessment and transfusion process support. Conclusion: the identified indicators make it possible to assess the transfusion process, although activities, such as care assessment, present few indicators, highlighting the need for studies on the subject and the construction of new indicators to support a more improved transfusion process assessment.


Objetivo: identificar indicadores relacionados con el proceso de transfusión. Método: revisión integrativa de la literatura, realizada entre marzo y mayo de 2022, en nueve fuentes de información de 2001 a 2021. Como estrategia de busca, se utilizaron los descriptores "Indicadores de Calidad en la Atención de Salud", "Indicadores de Servicio", "Indicadores Básicos de Salud", "Servicio de Hemoterapia", "Transfusión de Sangre", "Seguridad de la Sangre", con operadores booleanos "AND" y "OR" en tres idiomas, analizando 49 artículos. Resultados: se identificaron 53 indicadores, los cuales fueron agrupados en: gestión del stock de hemocomponentes, producción del proceso transfusional, evaluación del proceso transfusional y apoyo al proceso transfusional. Conclusión: los indicadores identificados posibilitan la evaluación del proceso transfusional, aunque actividades, como la evaluación del cuidado, presenten pocos indicadores, destacando la necesidad de estudios sobre el tema y la construcción de nuevos indicadores que apoyen una evaluación más perfeccionada del proceso de transfusión.


Assuntos
Humanos , Transfusão de Sangue , Indicadores de Serviços , Indicadores de Qualidade em Assistência à Saúde , Serviço de Hemoterapia , Segurança do Sangue
6.
Viruses ; 14(12)2022 11 23.
Artigo em Inglês | MEDLINE | ID: mdl-36560615

RESUMO

During the last few decades, efforts to increase the safety of blood and blood products have mainly focused on preventing the viral infections HCV, HIV, HBV and Treponema pallidum. The evolution of these approaches and the achieved increase in safety is shown for the last 25 years in Switzerland. In detail, the prevalences and incidences of the infection disease and the theoretical estimated residual risks (RR) of these blood-borne infections are presented. Prevalences, incidences and, in particular, the RR have decreased considerably over the last 25 years. This was achieved primarily by the adoption of strict criteria for the selection of blood donors, refined questionnaires, the introduction of increasingly sensitive serological screening tests and the implementation of nucleic acid testing (NAT) for these blood-borne pathogens. These NAT assays have significantly shortened the window period between infection and the first detection of the infectious agent in the blood of an infected individual. A form of "real life" comparison or confirmation is provided by the reported lookback procedures (LBP) and the haemovigilance data of the Swiss competent authority, Swissmedic. These data are in agreement, and thus support the very low prevalences, incidences and RR.


Assuntos
Infecções por HIV , Hepatite C , Humanos , Vírus da Hepatite B/genética , Segurança do Sangue , Treponema pallidum/genética , Suíça/epidemiologia , Programas de Rastreamento/métodos , Infecções por HIV/prevenção & controle , Hepatite C/epidemiologia , Doadores de Sangue , Técnicas de Amplificação de Ácido Nucleico
7.
Hematol., Transfus. Cell Ther. (Impr.) ; 44(4): 512-518, Oct.-dec. 2022. tab, graf
Artigo em Inglês | LILACS | ID: biblio-1421522

RESUMO

ABSTRACT Introduction: The safety of a blood transfusion practice is anchored on safe blood from a healthy donor, while further protecting the donor from future harm. This study aimed to evaluate the hematological parameters of blood donors in view of their donor category to aid in assessing the safety threshold in terms of donation frequency. Methods: This study made use of the descriptive cross-sectional design. The blood donors were bled and their samples analyzed using a hematology autoanalyzer. Results: A total of 178 male blood donors were recruited. Most of the donors were aged 18 to 39 years and were mostly students. A greater part of them were repeat donors who had donated blood more than four times. First- and second-time donors constituted the majority of the voluntary donors. While the total red cell count was significantly lower in repeat third-time donors, the hemoglobin and hematocrit of the first-time donors were significantly higher than those of the repeat fourth-time donors. The mean corpuscular hemoglobin (MCH) and mean corpuscular hemoglobin concentration (MCHC) of the first-time donors were significantly higher than those of the repeat fifth-time donors. The red cell distribution width (RDW) and mean platelet volume (MPV) were significantly lower in the first-time donors from those of the sixth- and seventh-time donors, respectively. Most of the fifth-time donors have subclinical anemia. There was more subclinical anemia in commercial donors than in voluntary donors. Conclusion: Repeat donors more than fifth-time donors are at risk of donation-induced iron deficiency anemia.


Assuntos
Humanos , Masculino , Adolescente , Adulto , Pessoa de Meia-Idade , Adulto Jovem , Doadores de Sangue , Padrões de Referência , Segurança do Sangue , Anemia
9.
Transfusion ; 62(5): 982-999, 2022 05.
Artigo em Inglês | MEDLINE | ID: mdl-35441384

RESUMO

BACKGROUND: The Recipient Epidemiology and Donor Evaluation Study-IV-Pediatric (REDS-IV-P) is a new iteration of prior National Heart, Lung, and Blood Institute (NHLBI) REDS programs that focus on improving transfusion recipient outcomes across the lifespan as well as the safety and availability of the blood supply. STUDY DESIGN AND METHODS: The US program includes blood centers and hospitals (22 including 6 free-standing Children's hospitals) in four geographic regions. The Brazilian program has 5 participating hemocenters. A Center for Transfusion Laboratory Studies (CTLS) and a Data Coordinating Center (DCC) support synergistic studies and activities over the 7-year REDS-IV-P program. RESULTS: The US is building a centralized, vein-to-vein (V2V) database, linking information collected from blood donors, their donations, the resulting manufactured components, and data extracts from hospital electronic medical records of transfused and non-transfused patients. Simultaneously, the Brazilian program is building a donor, donation, and component database. The databases will serve as the backbone for retrospective and prospective observational studies in transfusion epidemiology, transfusion recipient outcomes, blood component quality, and emerging blood safety issues. Special focus will be on preterm infants, patients with sickle cell disease, thalassemia or cancer, and the effect of donor biologic variability and component manufacturing on recipient outcomes. A rapid response capability to emerging safety threats has resulted in timely studies related to Severe Acute Respiratory Syndrome Corona Virus-2 (SARS-CoV-2). CONCLUSIONS: The REDS-IV-P program endeavors to improve donor-recipient-linked research with a focus on children and special populations while also maintaining the flexibility to address emerging blood safety issues.


Assuntos
Doadores de Sangue , COVID-19 , Segurança do Sangue , COVID-19/epidemiologia , Criança , Humanos , Lactente , Recém-Nascido , Recém-Nascido Prematuro , Longevidade , Estudos Retrospectivos , SARS-CoV-2
10.
Transfusion ; 62(5): 1010-1018, 2022 05.
Artigo em Inglês | MEDLINE | ID: mdl-35442519

RESUMO

BACKGROUND: Transfusion carries a risk of transfusion reaction that is often underdiagnosed due to reliance on passive reporting. The study investigated the utility of digital methods to identify potential transfusion reactions, thus allowing real-time intervention for affected patients. METHOD: The hemovigilance unit monitored 3856 patients receiving 43,515 transfusions under the hemovigilance program. Retrospective comparison data included 298,498 transfusions. Transfusion medicine physicians designed and validated algorithms in the electronic health record that analyze discrete data, such as vital sign changes, to assign a risk score during each transfusion. Dedicated hemovigilance nurses remotely monitor all patients and perform real-time chart reviews prioritized by risk score. When a reaction is suspected, a hemovigilance trained licensed clinician responds to manage the patient and ensure data collection. Board-certified transfusion medicine physicians reviewed data and classified transfusion reactions under various categories according to the Centers for Disease Control hemovigilance definitions. RESULTS: Transfusion medicine physicians diagnosed 564 transfusion reactions (1.3% of transfusions)-a 524% increase compared to the previous passive reporting. The rapid response provider reached the bedside on average at 12.4 min demonstrating logistic feasibility. While febrile reactions were most diagnosed, recognition of transfusion-associated circulatory overload demonstrated the greatest relative increase. Auditing and education programs further enhanced transfusion reaction awareness. DISCUSSION: The model of digitally-enabled expert real-time review of clinical data that prompts rapid response improved recognition of transfusion reactions. This approach could be applied to other patient deterioration events such as early identification of sepsis.


Assuntos
Segurança do Sangue , Reação Transfusional , Transfusão de Sangue , Febre , Humanos , Estudos Retrospectivos
11.
Transfus Apher Sci ; 61(2): 103404, 2022 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-35288055

RESUMO

Transfusion-associated graft versus host disease (TA-GVHD) is a highly morbid and often fatal adverse event associated with transfusion of cellular blood products [platelets, red blood cells (RBCs) and whole blood] and more rarely with never-frozen plasma products. It is caused by residual viable donor T-lymphocytes that proliferate and actively target recipient tissues. Selective or universal irradiation of blood components using gamma-irradiation and more recently, X-ray irradiation, are the most commonly applied interventions and have been validated by the demonstration of in vitro T-lymphocyte inactivation, in murine models of TA-GVHD and by years of clinical experience. Irradiation, however, has multiple limitations including a sharp dose-response curve that renders quality control of dosage critically important, the use of radioactive radiation sources that are a terrorism risk, and selective implementation in many countries that leads to inadvertent omission and patient risk exposure. Certain pathogen reduction technologies (PRT) for platelets have been approved by regulatory authorities and endorsed by professional societies as an alternative to irradiation for reducing the risk of TA-GVHD, and PRT for RBCs and whole blood are in development. While the mechanism of action of T-lymphocyte inactivation differs from gamma/X-ray irradiation, the impact on T-lymphocyte inactivation for PRT is equivalent or superior to that of irradiation as demonstrated by sensitive in vitro lymphocyte proliferation assays and in vivo mouse models that approximate human TA-GVHD. Clinical trials and cumulative routine-use experience attest to the efficacy of PRT when used as an alternative to irradiation. While T-lymphocyte inactivation efficacy varies between PRT platforms, the implementation of PRT for platelets increases blood safety for patients beyond the mitigation of TA-GVHD, by decreasing the risk of transfusion transmitted infections with known viruses, bacteria and parasites as well as emerging pathogens.


Assuntos
Doença Enxerto-Hospedeiro , Reação Transfusional , Animais , Transfusão de Componentes Sanguíneos/efeitos adversos , Segurança do Sangue , Transfusão de Sangue , Doença Enxerto-Hospedeiro/etiologia , Doença Enxerto-Hospedeiro/prevenção & controle , Humanos , Camundongos , Reação Transfusional/etiologia
12.
Artigo em Alemão | MEDLINE | ID: mdl-35024894

RESUMO

Infections with hepatitis B, C, and E virus (HBV, HCV, and HEV) can be transmitted via blood and cause severe acute or chronic liver infections. To ensure the safety of blood donations and protect recipients from virus transmissions, blood donations in Germany are tested for viral genomes using nucleic acid amplification techniques (NATs) as well as for viral antigens and antibodies by serological testing. This article describes the relevant regulations on the safety of blood and blood products in Germany and the various screening methods. The safety of blood products is assessed.Currently used NAT methods for detection of hepatitis viruses are based either on polymerase chain reaction (PCR) or isothermal methods such as transcription-mediated amplification (TMA), which enable a highly sensitive detection of viral infections and thereby contribute to the reduction of the diagnostic window. Antigen tests for the detection of viral surface protein of hepatitis B virus in blood donations were introduced in the 1970s in order to prevent potential transmissions. Since the introduction of mandatory testing for HCV-specific antibodies in 1992, HCV NAT testing in 1999, anti-HBc antibody testing in 2006, and the non-mandatory HBV NAT, which is voluntarily performed by most of the blood establishments, blood safety has increased tremendously. Only a few isolated cases of transfusion-transmitted infections in the early window period have been reported since. The success of the recent introduction of mandatory HEV NAT testing in 2020 will have to be assessed in the upcoming years. Besides blood donor screening, the system for blood safety in Germany is supplemented by additional measures for donor selection and pathogen inactivation.


Assuntos
Antígenos de Superfície da Hepatite B , Hepatite B , Doadores de Sangue , Segurança do Sangue , DNA Viral , Alemanha , Hepatite B/diagnóstico , Hepatite B/prevenção & controle , Humanos , Programas de Rastreamento
13.
Hematol., Transfus. Cell Ther. (Impr.) ; 44(1): 17-25, Jan.-Mar. 2022. tab, graf
Artigo em Inglês | LILACS | ID: biblio-1364898

RESUMO

Abstract Introduction With the outbreak of COVID-19 and its containment measures, blood centers faced a huge challenge in balancing blood demand and supply and devising a preparedness plan to withstand the uncertain situation. This study assesses the effect of the COVID-19 pandemic on blood transfusion services and discusses the appropriate mitigation strategies adopted. Methods We analyzed our center's blood transfusion services during the first half-period of the pandemic (Y3) and non-pandemic years 2018(Y1) and 2019(Y2) in two-quarters Q1 (pre-lockdown), from January to March and Q2 (post-lockdown), from April to June. The blood donation variables, the packed red blood cells (PRBCs) demand and the utilization pattern were compared between pandemic (Y3) and non-pandemic years (Y1 and Y2) in each quarter. The mitigation strategy adopted at every step of the transfusion service is highlighted. Results During post-lockdown (Q2) of the pandemic year (Y3), the blood donation was majorly by repeat donors (83%) from the in-house site (82.5%). Furthermore, the proportion of outdoor donation, deferral, blood collection, demand and issue demonstrated a significant drop of 50%, 32.6%, 33%, 31.8% and 32.3%, respectively, in comparison to Q2 of the non-pandemic years (Y1 and Y2), with a statistically significant difference for surgical and hemorrhagic indications (p < 0.05). Coping strategies, such as blood donor education and motivation using e-platforms emphasizing eligibility during the pandemic, staggering of donor in-flow, postponement of elective surgeries and donor and staff' COVID-19 safety assurance, were followed. Conclusion The timely adoption of coping strategies played a crucial role in the better handling of shortcomings at our center's blood transfusion services caused by the COVID-19 pandemic.


Assuntos
Doadores de Sangue , Segurança do Sangue , COVID-19 , Bancos de Sangue , Transfusão de Sangue , Coronavirus , Pandemias
14.
JAMA Netw Open ; 4(10): e2128615, 2021 10 01.
Artigo em Inglês | MEDLINE | ID: mdl-34618037

RESUMO

Importance: The number of clinics marketing stem cell products for joint diseases, chronic pain, and most recently, COVID-19, has increased despite warnings from the US Food and Drug Administration that stem cell products for these and other indications have not been proven safe or effective. Objective: To examine bacterial infections in 20 patients who received umbilical cord blood-derived products marketed as stem cell treatment. Design, Setting, and Participants: This case series is a national public health investigation including case-finding, medical record review and abstraction, and laboratory investigation, including sterility testing of products and whole-genome sequencing of patient and product isolates. Participants included patients who developed bacterial infections following administration of umbilical cord blood-derived products marketed as stem cell treatment during August 2017 to September 2018. Data analysis was performed from March 2019 to September 2021. Exposures: Umbilical cord blood-derived products marketed as stem cell treatment. Main Outcomes and Measures: Data were collected on patient infections and exposures. The Centers for Disease Control and Prevention performed sterility testing on undistributed and distributed vials of product marketed as stem cell treatment and performed whole-genome sequencing to compare patient and product bacterial isolates. Results: Culture-confirmed bacterial infections were identified in 20 patients (median [range] age, 63 [2-89] years; 13 male patients [65%]) from 8 US states who sought stem cell treatment for conditions including pain, osteoarthritis, rheumatoid arthritis, and injury; all but 1 required hospitalization. The most frequently isolated bacteria from patients with infections were common enteric species, including Escherichia coli (14 patients) and Enterobacter cloacae (7 patients). Of unopened, undistributed products sampled for testing, 65% (22 of 34 vials) were contaminated with at least 1 of 16 bacterial species, mostly enteric. A patient isolate from Arizona matched isolates obtained from products administered to patients in Florida, and patient isolates from Texas matched undistributed product sent from the company in California. Conclusions and Relevance: Unapproved stem cell products can expose patients to serious risks without proven benefit. Sequencing results suggest a common source of extensive contamination, likely occurring during the processing of cord blood into product. Patients and health care practitioners who are considering the use of unapproved products marketed as stem cell treatment should be aware of their unproven benefits and potential risks, including serious infections.


Assuntos
Infecções Bacterianas/etiologia , Segurança do Sangue/estatística & dados numéricos , Transplante de Células-Tronco de Sangue do Cordão Umbilical/efeitos adversos , Surtos de Doenças , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Infecções Bacterianas/epidemiologia , Infecções Bacterianas/prevenção & controle , Segurança do Sangue/normas , Centers for Disease Control and Prevention, U.S. , Criança , Pré-Escolar , Transplante de Células-Tronco de Sangue do Cordão Umbilical/normas , Feminino , Humanos , Masculino , Marketing , Pessoa de Meia-Idade , Avaliação de Resultados em Cuidados de Saúde , Vigilância em Saúde Pública , Estados Unidos/epidemiologia , United States Food and Drug Administration , Adulto Jovem
16.
Transfusion ; 61(10): 2869-2876, 2021 10.
Artigo em Inglês | MEDLINE | ID: mdl-34448199

RESUMO

BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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.


Assuntos
Segurança do Sangue , Transfusão de Plaquetas/efeitos adversos , Adolescente , Plaquetas/citologia , Criança , Pré-Escolar , Feminino , Humanos , Lactente , Masculino , Estudos Retrospectivos , Fatores de Risco
17.
Transfus Apher Sci ; 60(4): 103207, 2021 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-34353706

RESUMO

Blood transfusions come with risks and high costs, and should be utilized only when clinically indicated. Decisions to transfuse are however not always well informed, and lack of clinician knowledge and education on good clinical transfusion practices contribute to the inappropriate use of blood. Low and middle-income countries in particular take much strain in their efforts to address blood safety challenges, demand-supply imbalances, high blood costs as well as high disease burdens, all of which impact blood usage and blood collections. Patient blood management (PBM), which is a patient-focused approach aimed at improving patient outcomes by preemptively diagnosing and correcting anaemia and limiting blood loss by cell salvage, coagulation optimization and other measures, has become a major approach to addressing many of the challenges mentioned. The associated decrease in the use of blood and blood products may be perceived as being in competition with blood conservation measures, which is the more traditional, but primarily product-focused approach. In this article, we hope to convey the message that PBM and blood conservation should not be seen as competing concepts, but rather complimentary strategies with the common goal of improving patient care. This offers opportunity to improve the culture of transfusion practices with relief to blood establishments and clinical services, not only in South Africa and LMICs, but everywhere. With the COVID-19 pandemic impacting blood supplies worldwide, this is an ideal time to call for educational interventions and awareness as an active strategy to improve transfusion practices, immediately and beyond.


Assuntos
Bancos de Sangue/organização & administração , Transfusão de Sangue , Procedimentos Médicos e Cirúrgicos sem Sangue , Anemia/terapia , Bancos de Sangue/economia , Perda Sanguínea Cirúrgica , Segurança do Sangue , Transfusão de Sangue/economia , Infecções Transmitidas por Sangue/prevenção & controle , Procedimentos Médicos e Cirúrgicos sem Sangue/economia , COVID-19 , Tomada de Decisão Clínica , Países em Desenvolvimento , Seleção do Doador/economia , Medicina Baseada em Evidências , Feminino , Infecções por HIV/epidemiologia , Infecções por HIV/prevenção & controle , Necessidades e Demandas de Serviços de Saúde , Humanos , Masculino , Pandemias , Hemorragia Pós-Parto/terapia , Guias de Prática Clínica como Assunto , Gravidez , Prevalência , Utilização de Procedimentos e Técnicas , SARS-CoV-2 , África do Sul/epidemiologia , Medicina Transfusional/educação
19.
Transfusion ; 61(8): 2392-2400, 2021 08.
Artigo em Inglês | MEDLINE | ID: mdl-34224581

RESUMO

BACKGROUND: Undisclosed antiretroviral drug (ARV) use among blood donors who tested HIV antibody positive, but RNA negative, was previously described by our group. Undisclosed ARV use represents a risk to blood transfusion safety. We assessed the prevalence of and associations with undisclosed ARV use among HIV-positive donors who donated during 2017. STUDY DESIGN AND METHODS: South African National Blood Service (SANBS) blood donors are screened by self-administered questionnaire, semi-structured interview, and individual donation nucleic acid amplification testing for HIV. Stored samples from HIV-positive donations were tested for ARV and characterized as recent/longstanding using lag avidity testing. RESULTS: Of the 1462 HIV-positive donations in 2017, 1250 had plasma availability for testing of which 122 (9.8%) tested positive for ARV. Undisclosed ARV use did not differ by gender (p = .205) or ethnicity (p = .505) but did differ by age category (p < .0001), donor (p < .0001), clinic type (p = .012), home province (p = .01), and recency (p < .0001). Multivariable logistic regression found older age (adjusted odds ratio [aOR] 3.73, 95% confidence interval [CI] 1.98-7.04 for donors >40 compared with those <21), first-time donation (aOR 5.24; 95% CI 2.48-11.11), and donation in a high HIV-prevalence province (aOR 9.10; 95% CI 2.70-30.72) compared with Northern Rural provinces to be independently associated with undisclosed ARV use. DISCUSSION: Almost 1 in 10 HIV-positive blood donors neglected to disclose their HIV status and ARV use. Demographic characteristics of donors with undisclosed ARV use differed from those noted in other study. Underlying motivations for nondisclosure among blood donors remain unclear and may differ from those in other populations with significant undisclosed ARV use.


Assuntos
Doadores de Sangue , Segurança do Sangue , Infecções por HIV/diagnóstico , Adulto , Estudos Transversais , Seleção do Doador , Feminino , HIV/isolamento & purificação , Infecções por HIV/epidemiologia , Teste de HIV , Humanos , Masculino , Técnicas de Amplificação de Ácido Nucleico , África do Sul/epidemiologia , Adulto Jovem
20.
Transfusion ; 61 Suppl 1: S80-S89, 2021 07.
Artigo em Inglês | MEDLINE | ID: mdl-34269444

RESUMO

BACKGROUND: Collection of non-leukoreduced citrate-phosphate-dextrose-adenine (CPDA-1) whole blood is performed in walking blood banks. Blood collected under field conditions may have increased risk of bacterial contamination. This study was conducted to examine the effects of WBC reduction and storage temperature on growth of Escherichia coli (ATCC® 25922™) in CPDA-1 whole blood. METHODS: CPDA-1 whole blood of 450 ml from 10 group O donors was inoculated with E. coli. Two hours after inoculation, the test bags were leukoreduced with a platelet-sparing filter. The control bags remained unfiltered. Each whole blood bag was then split into three smaller bags for further storage at 2-6°C, 20-24°C, or 33-37°C. Bacterial growth was quantified immediately, 2 and 3 h after inoculation, on days 1, 3, 7, and 14 for all storage temperatures, and on days 21 and 35 for storage at 2-6°C. RESULTS: Whole blood was inoculated with a median of 19.5 (range 12.0-32.0) colony-forming units per ml (CFU/ml) E. coli. After leukoreduction, a median of 3.3 CFU/ml (range 0.0-33.3) E. coli remained. In the control arm, the WBCs phagocytized E. coli within 24 h at 20-24°C and 33-37°C in 9 of 10 bags. During storage at 2-6°C, a slow self-sterilization occurred over time with and without leukoreduction. CONCLUSIONS: Storage at 20-24°C and 33-37°C for up to 24 h before leukoreduction reduces the risk of E. coli-contamination in CPDA-1 whole blood. Subsequent storage at 2-6°C will further reduce the growth of E. coli.


Assuntos
Preservação de Sangue , Segurança do Sangue , Infecções por Escherichia coli/microbiologia , Escherichia coli/crescimento & desenvolvimento , Procedimentos de Redução de Leucócitos , Adenina/química , Preservação de Sangue/métodos , Citratos/química , Escherichia coli/isolamento & purificação , Glucose/química , Humanos , Temperatura
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