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1.
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2.
  • Behr-Gross, M. -E, et al. (författare)
  • Contributions of the Council of Europe's Blood Transfusion Steering Committee to the determination of rules for the selection of donors of blood and blood components and the study of sexual behaviors having an impact on blood safety
  • 2013
  • Ingår i: Transfusion Clinique et Biologique. - : Elsevier BV. - 1246-7820 .- 1953-8022. ; 20:2, s. 127-138
  • Tidskriftsartikel (refereegranskat)abstract
    • In November 2009, the Council of Europe's Blood Transfusion Steering Committee created a group of experts to explore the problem of behaviors having an impact on the management of donors of blood and blood components and on blood transfusion safety in Europe. This ad hoc group sought a harmonised interpretation of temporary exclusion (or temporary deferral), as opposed to permanent exclusion (or permanent deferral), in the context of the selection of donors of blood and blood components. It was also given the mandate to assess, on the basis of available data, the possibility of differentiating "at risk" behaviours from behaviours "at high risk" of contamination by serious infectious diseases transmitted by blood, blood components or derived therapeutic products. The primary objective of this work was to ensure the safety of blood, blood components and derived therapeutic products for future recipients by promoting a risk analysis-based approach, given that some countries envisaged amending their provisions for donor selection. However, a risk analysis can only be performed on groups, not individuals, which may give the impression of a discriminatory approach, so it needed to be justified in the context of transfusion safety. A collaborative project, which included an investigation phase, led to the drafting of a technical memorandum that summarised the data collected in ten Council of Europe member states on the selection criteria for blood donors and the epidemiology of infectious diseases (with a focus on human immunodeficiency virus) in the general population and among blood donors. The technical memorandum was published in 2011 on the European Directorate for the Quality of Medicines and Healthcare website dedicated to this project. A draft resolution of the Committee of Ministers of the Council of Europe was then developed by the Council of Europe's Blood Transfusion Steering Committee. This text was circulated among member and observer states of the Council of Europe for review and comments.
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3.
  • Dahl, Viktor, et al. (författare)
  • Transmission of viral hepatitis through blood transfusion in Sweden, 1968 to 2012
  • 2020
  • Ingår i: Eurosurveillance. - : European Centre for Disease Control and Prevention (ECDC). - 1025-496X .- 1560-7917. ; 25:29, s. 7-15
  • Tidskriftsartikel (refereegranskat)abstract
    • Introduction: Viral hepatitis remains a significant threat to transfusion safety, although largely mitigated by donor screening. Aim: Our objective was to estimate the past and present burden of transfusion transmission of all types of viral hepatitis (A to E) and to find undiagnosed infections with hepatitis C virus (HCV). Method: We performed a retrospective cohort study using a database of the entire computerised transfusion experience of Sweden from 1968 to 2012 and linking it to a nationwide database of notifiable infections. We then used two independent statistical approaches. Firstly, we tracked recipients of blood from donors with confirmed viral hepatitis. Secondly, we computed a donor-specific risk score, defined as the difference between the observed and the expected number of HCV infections among all previous recipients of all donors, where thresholds were determined using simulation. Results: Among 1,146,307 transfused patients, more than 5,000 were infected with HCV. Transfusion transmission only occurred before 1992 when donor screening had been completely implemented. Overall, we found 44 donors and 1,180 recipients likely to be infected with HCV who were still alive but who remained undiagnosed. Conclusion: There is still a substantial number of individuals in Sweden who have probably been infected with HCV through blood transfusion and who are still unaware of their infection. We recommend that a follow-up study should be conducted to validate the method we used by approaching these individuals and offer testing. This would also serve as an opportunity to offer treatment to those who remain infected.
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4.
  • Edgren, Gustaf, et al. (författare)
  • Improving health profile of blood donors as a consequence of transfusion safety efforts
  • 2007
  • Ingår i: Transfusion. - : Wiley. - 0041-1132 .- 1537-2995. ; 47:11, s. 2017-2024
  • Tidskriftsartikel (refereegranskat)abstract
    • Background: Transfusion safety rests heavily on the health of blood donors. Although they are perceived as being healthier than average, little is known about their long-term disease patterns and to which extent the blood banks' continuous efforts to optimize donor selection has resulted in improvements. Mortality and cancer incidence among blood donors in Sweden and Denmark was investigated. Study Design and Methods: All computerized blood bank databases were compiled into one database, which was linked to national population and health data registers. With a retrospective cohort study design, 1,110,329 blood donors were followed for up to 35 years from first computer-registered blood donation to death, emigration, or December 31, 2002. Standardized mortality and incidence ratios expressed relative risk of death and cancer comparing blood donors to the general population. Results: Blood donors had an overall mortality 30 percent lower (99% confidence interval [CI] 29%-31%) and cancer incidence 4 percent lower (99% CI 2%-5%) than the background population. Mortality rates and cancer incidence were lowest for outcomes that are recognized as being related to lifestyle factors such as smoking or to the selection criteria for blood donation. Blood donors recruited in more recent years exhibited a lower relative mortality than those who started earlier. Conclusion: Blood donors enjoy better than average health. Explicit and informal requirements for blood donation in Scandinavia, although mostly of a simple nature, have successfully refined the selection of a particularly healthy subpopulation.
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5.
  • Edgren, G., et al. (författare)
  • Searching for unknown transfusion-transmitted hepatitis viruses : a binational cohort study of 1.5 million transfused patients
  • 2018
  • Ingår i: Journal of Internal Medicine. - : WILEY. - 0954-6820 .- 1365-2796. ; 284:1, s. 92-103
  • Tidskriftsartikel (refereegranskat)abstract
    • Background. Both hepatitis B and C viruses were transmitted through blood transfusion before implementation of donor screening. The existence of additional, yet unknown transfusion transmittable agents causing liver disease could have important public health implications.Methods. Analyses were based on the Scandinavian Donations and Transfusions (SCANDAT2) database. Cox regression models were used to estimate the hazard ratio (HR) of developing chronic liver disease in recipients of blood from donors who later developed any chronic liver disease compared to recipients who received blood transfusion from healthy donors. We also studied whether the risk of liver disease was increased in patients who received units from high-risk' donors, defined as donors who had a higher than expected occurrence of liver disease amongst their previous recipients. All analyses were stratified before and after 1992 to account for the effect of screening for hepatitis C virus.Results. A total of 1 482 922 transfused patients were included in the analyses. Analyses showed evidence of transfusion transmission of liver diseases before, but not after the implementation of hepatitis C virus screening in 1992, with HRs for any liver disease of 1.38 [95% confidence interval (CI), 1.30-1.46] and 0.99 (95% CI, 0.91-1.07), before and after 1992, respectively. Similarly, blood components from 'high-risk' donors conferred increased risks before, but not after 1992.Conclusions. Our data provide no evidence for transfusion transmission of agents causing liver disease after the implementation of screening for hepatitis B and C, and suggest that if such transmission does occur, it is rare.
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6.
  • Edgren, Gustaf, et al. (författare)
  • The new Scandinavian Donations and Transfusions database (SCANDAT2) : a blood safety resource with added versatility
  • 2015
  • Ingår i: Transfusion. - : Wiley. - 0041-1132 .- 1537-2995. ; 55:7, s. 1600-1606
  • Tidskriftsartikel (refereegranskat)abstract
    • BackgroundRisks of transfusion-transmitted disease are currently at a record low in the developed world. Still, available methods for blood surveillance might not be sufficient to detect transmission of diseases with unknown etiologies or with very long incubation periods. Study Design and MethodsWe have previously created the anonymized Scandinavian Donations and Transfusions (SCANDAT) database, containing data on blood donors, blood transfusions, and transfused patients, with complete follow-up of donors and patients for a range of health outcomes. Here we describe the re-creation of SCANDAT with updated, identifiable data. We collected computerized data on blood donations and transfusions from blood banks covering all of Sweden and Denmark. After data cleaning, two structurally identical databases were created and the entire database was linked with nationwide health outcomes registers to attain complete follow-up for up to 47 years regarding hospital care, cancer, and death. ResultsAfter removal of erroneous records, the database contained 25,523,334 donation records, 21,318,794 transfusion records, and 3,692,653 unique persons with valid identification, presently followed over 40 million person-years, with possibility for future extension. Data quality is generally high with 96% of all transfusions being traceable to their respective donation(s) and a very high (>97%) concordance with official statistics on annual number of blood donations and transfusions. ConclusionsIt is possible to create a binational, nationwide database with almost 50 years of follow-up of blood donors and transfused patients for a range of health outcomes. We aim to use this database for further studies of donor health, transfusion-associated risks, and transfusion-transmitted disease.
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7.
  • Edgren, Gustaf, et al. (författare)
  • Transmission of Neurodegenerative Disorders Through Blood Transfusion A Cohort Study
  • 2016
  • Ingår i: Annals of Internal Medicine. - 0003-4819 .- 1539-3704. ; 165:5, s. 316-
  • Tidskriftsartikel (refereegranskat)abstract
    • Background: The aggregation of misfolded proteins in the brain occurs in several neurodegenerative disorders. Aberrant protein aggregation is inducible in rodents and primates by intracerebral inoculation. Possible transfusion transmission of neurodegenerative diseases has important public health implications. Objective: To investigate possible transfusion transmission of neurodegenerative disorders. Design: Retrospective cohort study. Setting: Nationwide registers of transfusions in Sweden and Denmark. Participants: 1 465 845 patients who received transfusions between 1968 and 2012. Measurements: Multivariable Cox regression models were used to estimate hazard ratios for dementia of any type, Alzheimer disease, and Parkinson disease in patients receiving blood transfusions from donors who were later diagnosed with any of these diseases versus patients who received blood from healthy donors. Whether excess occurrence of neurodegenerative disease occurred among recipients of blood from a subset of donors was also investigated. As a positive control, transmission of chronic hepatitis before and after implementation of hepatitis C virus screening was assessed. Results: Among included patients, 2.9% received a transfusion from a donor diagnosed with one of the studied neurodegenerative diseases. No evidence of transmission of any of these diseases was found, regardless of approach. The hazard ratio for dementia in recipients of blood from donors with dementia versus recipients of blood from healthy donors was 1.04 (95% CI, 0.99 to 1.09). Corresponding estimates for Alzheimer disease and Parkinson disease were 0.99 (CI, 0.85 to 1.15) and 0.94 (CI, 0.78 to 1.14), respectively. Hepatitis transmission was detected before but not after implementation of hepatitis C virus screening. Limitation: Observational study design, underascertainment of the outcome, and possible insufficient statistical power. Conclusion: The data provide no evidence for the transmission of neurodegenerative diseases and suggest that if transmission does occur, it is rare.
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8.
  • Garraud, O., et al. (författare)
  • A European survey on donor deferral for allergy : Rationale and initial results of a survey in 35 countries
  • 2017
  • Ingår i: Transfusion Clinique et Biologique. - : Elsevier BV. - 1246-7820 .- 1953-8022. ; 24:1, s. 34-35
  • Tidskriftsartikel (refereegranskat)abstract
    • Allergy accounts to near 0.5% of all reported transfusion adverse events. The responsibility of blood components themselves and - therefore - of blood donors is still questioned. The European Community undertook a large international survey to address the consistency and homogeneity of medical selection of blood donors with regard to the risk of allergy, and especially of transferring allergy to recipients. This short report presents the salient points of the survey, stressing that there is inconsistency in addressing the allergy question within countries or systems, with paths of improvement.
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9.
  • Grau, Katrine, et al. (författare)
  • No association between frequent apheresis donation and risk of fractures : a retrospective cohort analysis from Sweden
  • 2017
  • Ingår i: Transfusion. - : Wiley. - 0041-1132 .- 1537-2995. ; 57:2, s. 390-396
  • Tidskriftsartikel (refereegranskat)abstract
    • BACKGROUND: Citrate anticoagulation during apheresis induces transient alterations in calcium homeostasis. It is unknown whether the repeated, transient alterations in calcium homeostasis experienced by repeated apheresis donors affects bone turnover to increase fracture risk. Our aim was to investigate the risk of osteoporotic and nonosteoporotic fracture among voluntary, frequent apheresis donors. STUDY DESIGN AND METHODS: All apheresis donors were identified from the Scandinavian Donations and Transfusions database (SCANDAT2), which includes information on over 1.6 million blood donors from Sweden and Denmark from the years 1968 and 1981, respectively. Only data from Sweden were used for these analyses. Information on fractures was obtained by linking SCANDAT2 to hospital registers. Poisson regression was used to compute incidence rate ratios of fractures in relation to the cumulative number of apheresis donations, both overall and in fixed time windows. RESULTS: In total, 140,289 apheresis donors (67,970 women and 72,319 men) were identified from the SCANDAT2 database and were followed for up to 23 years. We observed no association between the frequency of apheresis donation and the risk of fracture either in the overall study period or during fixed-length time windows. The incidence rate ratio of fractures in donors who had made 100 or more cumulative apheresis donations was 0.99(95% confidence interval, 0.92-1.06) compared with donors who had made from 9 to 24 donations. The results were similar in analyses stratified by sex and restricted to postmenopausal women. CONCLUSIONS: The absence of an association between repeated apheresis donation and fracture risk indicates that apheresis collection is safe with regard to bone health.
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10.
  • Halmin, Marit, et al. (författare)
  • Epidemiology of Massive Transfusion : A Binational Study From Sweden and Denmark
  • 2016
  • Ingår i: Critical Care Medicine. - 0090-3493 .- 1530-0293. ; 44:3, s. 468-477
  • Tidskriftsartikel (refereegranskat)abstract
    • Objective: There is an increasing focus on massive transfusion, but there is a paucity of comprehensive descriptions of the massively transfused patients and their outcomes. The objective of this study is to describe the incidence rate of massive transfusion, patient characteristics, and the mortality of massively transfused patients. Design: Descriptive cohort study. Setting: Nationwide study with data from Sweden and Denmark. Patients: The study was based on the Scandinavian Donations and Transfusions database, including all patients receiving 10 or more red cell concentrate transfusions in Sweden from 1987 and in Denmark from 1996. A total of 92,057 patients were included. Patients were followed until the end of 2012. Measurements and Main Results: Descriptive statistics were used to characterize the patients and indications. Post transfusion mortality was expressed as crude 30-day mortality and as long-term mortality using the Kaplan-Meier method and using standardized mortality ratios. The incidence of massive transfusion was higher in Denmark (4.5 per 10,000) than in Sweden (2.5 per 10,000). The most common indication for massive transfusion was major surgery (61.2%) followed by trauma (15.4%). Massive transfusion due to obstetrical bleeding constituted only 1.8%. The overall 5-year mortality was very high (54.6%), however with large differences between indication groups, ranging from 91.1% among those transfused for a malignant disease without surgery to 1.7% among patients transfused for obstetrical bleeding. The early standardized mortality ratios were high and decreased thereafter, but remained elevated throughout the time period. Conclusions: This large-scale study based on nationwide data from Sweden and Denmark describes the complete range of massive transfusion. We report a nonnegligible incidence and both a high absolute mortality and high standardized mortality ratio. The general pattern was similar for Sweden and Denmark, and we believe that similar patterns may be found in other high-resource countries. The study provides a relevant background for clinicians and researchers for designing future studies in this field.
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11.
  • Halmin, Märit, et al. (författare)
  • Length of Storage of Red Blood Cells and Patient Survival After Blood Transfusion : A Binational Cohort Study
  • 2017
  • Ingår i: Annals of Internal Medicine. - 0003-4819 .- 1539-3704. ; 166:4, s. 248-256
  • Tidskriftsartikel (refereegranskat)abstract
    • Background: Possible negative effects, including increased mortality, among persons who receive stored red blood cells (RBCs) have recently garnered considerable attention. Despite many studies, including 4 randomized trials, no consensus exists.Objective: To study the association between the length of RBC storage and mortality in a large population-based cohort of patients who received transfusions, allowing detection of small yet clinically significant effects.Design: Binational cohort study.Setting: All transfusion recipients in Sweden and Denmark. Patients: 854 862 adult patients who received transfusions from 2003 to 2012.Measurements: Patients were followed from first blood transfusion. Relative and absolute risks for death in 30 days or 1 year in relation to length of RBC storage were assessed by using 3 independent analytic approaches. All analyses were conducted by using Cox proportional hazards regression.Results: Regardless of the analytic approach, no association was found between the length of RBC storage and mortality. The difference in 30-day cumulative mortality between patients receiving blood stored for 30 to 42 days and those receiving blood stored for 10 to 19 days was -0.2% (95% CI, -0.5% to 0.1%). Even among patients who received more than 6 units of RBCs stored for 30 days or longer, the hazard ratio of death was 1.00 (CI, 0.96 to 1.05) compared with those who received no such units.Limitation: Observational study; risk of confounding by indication.Conclusion: Consistent with previous randomized trials, this study found no association between the length of storage of transfused RBCs and patient mortality. Results were homogeneous, with differences in absolute mortality consistently less than 1% among the most extreme exposure categories. These findings suggest that the current practice of storing RBCs for up to 42 days does not need to be changed.
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12.
  • Kamper-Jörgensen, Mads, et al. (författare)
  • Survival after blood transfusion
  • 2008
  • Ingår i: Transfusion. - : Wiley. - 0041-1132 .- 1537-2995. ; 48:12, s. 2577-2584
  • Tidskriftsartikel (refereegranskat)abstract
    • Long-term survival of transfusion recipients has rarely been studied. This study examines short- and long-term mortality among transfusion recipients and reports these as absolute rates and rates relative to the general population. Population-based cohort study of transfusion recipients in Denmark and Sweden followed for up to 20 years after their first blood transfusion. Main outcome measure was all-cause mortality. A total of 1,118,261 transfusion recipients were identified, of whom 62.0 percent were aged 65 years or older at the time of their first registered transfusion. Three months after the first transfusion, 84.3 percent of recipients were alive. One-, 5-, and 20-year posttransfusion survival was 73.7, 53.4, and 27.0 percent, respectively. Survival was slightly poorer in men than in women, decreased with increasing age, and was worst for recipients transfused at departments of internal medicine. The first 3 months after the first transfusion, the standardized mortality ratio (SMR) was 17.6 times higher in transfusion recipients than in the general population. One to 4 years after first transfusion, the SMR was 2.1 and even after 17 years the SMR remained significantly 1.3-fold increased. The survival and relative mortality patterns among blood transfusion recipients were characterized with unprecedented detail and precision. Our results are relevant to assessments of the consequences of possible transfusion-transmitted disease as well as for cost-benefit estimation of new blood safety interventions.
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14.
  • Norda, Rut A C, 1948- (författare)
  • Plasma as a Therapeutic Principle in Clinical Practice : With Special Reference to Sweden
  • 2007
  • Doktorsavhandling (övrigt vetenskapligt/konstnärligt)abstract
    • The newly established Swedish Apheresis Registry makes it possible to do national inter-center comparisons. This study was undertaken to describe and analyze the use of therapeutic apheresis and the adverse effects in such therapy. The special case of plasma exchange as rescue therapy in multi-organ failure, including renal failure, was also studied. In Sweden, plasma for transfusion is prepared and stored to ensure rapid availability. Due to new EU legislation, validation of such plasma was performed. The analysis indicated that the use of therapeutic apheresis was in line with recommendations of other international societies. The frequency and types of adverse effects were comparable to those reported in other studies from analogous time periods. Compared with other countries, it appears that more therapeutic resources are available in Sweden and that there is a lower frequency of adverse effects in specific procedures. No fatalities were reported. The unique comparison of differences between centers regarding plasma exchange identified areas for further improvement.The study on plasma exchange as rescue therapy in severe sepsis or septic shock is the second largest reported. The result was promising, with a survival rate of 82%. The rapid availability of plasma for transfusion appears to be of clinical importance in patients with early coagulopathy and severe trauma but the present selection and storage procedures for plasma lead to a time-dependent increase of the number of units with cold-induced activation of the contact system and C1 inhibitor consumption before day 14. Improvements of plasma quality can be attained by using plasma from male donors only and by reducing the storage time from 14 to 7 days. Further studies are needed to define the role of plasma exchange in severe sepsis/septic shock, to evaluate the outcome of each patient’s treatment and to establish the indications for the transfusion of plasma.
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17.
  • Norda, Rut, et al. (författare)
  • Complement activation products in liquid stored plasma and C3a kinetics after transfusion of autologous plasma
  • 2012
  • Ingår i: Vox Sanguinis. - Malden : Wiley-Blackwell. - 0042-9007 .- 1423-0410. ; 102:2, s. 125-133
  • Tidskriftsartikel (refereegranskat)abstract
    • Background and Objectives: Keeping a small stock of liquid plasma readily available for transfusion is common practise in Sweden. We report data on complement activation markers in plasma components during storage in the liquid state and the kinetics of C3a-desArg after transfusion of autologous plasma with high content of C3a-desArg.Material and Methods: Plasma components were prepared by apheresis or from whole blood. C3 fragments (C3a-desArg, C3d, g, iC3), and soluble terminal complement complex (sC5b-9) were investigated. C3a-desArg kinetics was investigated in regular apheresis donors.Results: Apheresis plasma prepared by membrane centrifugation had significantly higher level of C3a-desArg, C3d, g and sC5b-9 from day 0 and low iC3, than plasma prepared by other methods. By storage day 7, C3a-desArg -levels were above the reference value in 88% of all components. After re-infusion of autologous plasma with high C3a-desArg content, there were rapid a1 and a2-distribution followed by a slower b-elimination phase.Conclusion: Plasma components prepared by different methods and stored in the liquid phase differ significantly in the amount and timing of complement activation. C3a-desArg present in plasma is rapidly eliminated after transfusion. Autologous plasma could be used to study complement kinetics in different clinical situations.
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19.
  • Norda, Rut, et al. (författare)
  • Recognition of inter-center differences may help develop best practice : Analysis of data from the Swedish Apheresis Registry
  • 2008
  • Ingår i: Therapeutic apheresis and dialysis. - : Wiley. - 1744-9979. ; 12:5, s. 347-354
  • Tidskriftsartikel (refereegranskat)abstract
    • The Swedish Apheresis Registry is a National Quality Registry and performing intercenter comparisons can be done as one task. The purpose of this study was to evaluate differences in adverse effects (AE) associated with plasma exchange (PE) for the development of best practice. Six hundred and twenty reports of AE related to a total of 12 461 apheresis procedures performed during 1996-2002 were analyzed, and eight Swedish university hospital centers that reported AE every year were compared. About 70% of all PE in Sweden were performed in centers that also reported AE. During this period, there was no change in the proportion of PE procedures with AE, but there was a decrease in the frequency of prematurely interrupted procedures (2.1% to 1.3%, P=0.003). The mean frequency of moderate and severe AE was 5%. Adverse effects were more common when PE was performed in patients with Guillain-Barrel syndrome (GBS; 10%) or thrombotic thrombocytopenic purpura-hemolytic uremic syndrome (TTP-HUS; 8%) than in patients with macroglobulinemia/hyperviscosity syndromes (2%). In the eight centers, there was a four-fold difference in AE between the centers with the highest and the lowest frequency. The frequency of AE in GBS, TTP-HUS and macroglobulinemia/hyperviscosity syndromes differed four-fold, while the frequency of specified symptoms differed more than four-fold. The indications and the choice of substitution fluids could explain some of these differences. The results of the study have initiated changes in practice. The identification of significant intercenter differences in the frequency and symptoms of AE has started improvement in current PE practices.
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20.
  • Norda, Rut, et al. (författare)
  • Recognition of Intercenter Differences May Help Develop Best Practice
  • 2008
  • Ingår i: Therapeutic Apheresis and Dialysis. - : Wiley. - 1744-9979. ; 12:5, s. 347-54
  • Tidskriftsartikel (refereegranskat)abstract
    • The Swedish Apheresis Registry is a National Quality Registry and performing intercenter comparisons can be done as one task. The purpose of this study was to evaluate differences in adverse effects (AE) associated with plasma exchange (PE) for the development of best practice. Six hundred and twenty reports of AE related to a total of 12 461 apheresis procedures performed during 1996-2002 were analyzed, and eight Swedish university hospital centers that reported AE every year were compared. About 70% of all PE in Sweden were performed in centers that also reported AE. During this period, there was no change in the proportion of PE procedures with AE, but there was a decrease in the frequency of prematurely interrupted procedures (2.1% to 1.3%, P=0.003). The mean frequency of moderate and severe AE was 5%. Adverse effects were more common when PE was performed in patients with Guillain-Barrel syndrome (GBS; 10%) or thrombotic thrombocytopenic purpura-hemolytic uremic syndrome (TTP-HUS; 8%) than in patients with macroglobulinemia/hyperviscosity syndromes (2%). In the eight centers, there was a four-fold difference in AE between the centers with the highest and the lowest frequency. The frequency of AE in GBS, TTP-HUS and macroglobulinemia/hyperviscosity syndromes differed four-fold, while the frequency of specified symptoms differed more than four-fold. The indications and the choice of substitution fluids could explain some of these differences. The results of the study have initiated changes in practice. The identification of significant intercenter differences in the frequency and symptoms of AE has started improvement in current PE practices.
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21.
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22.
  • Norda, Rut, et al. (författare)
  • The impact of plasma preparations and their storage time on short-term posttransfusion mortality : A population-based study using the Scandinavian Donation and Transfusion database
  • 2012
  • Ingår i: Journal of Trauma and Acute Care Surgery. - 2163-0755 .- 2163-0763. ; 72:4, s. 954-961
  • Tidskriftsartikel (refereegranskat)abstract
    • BACKGROUND: The treatment of coagulopathy and bleeding in severe trauma requires rapid delivery of large amounts of plasma to emergency wards. The resulting need for adequate supplies of nonfrozen or thawed plasma has consequences for storage strategies. Using extensive population data from a setting where both fresh-frozen plasma (FFP) and cold-stored liquid plasma were used, this study investigates whether there is an association between short-term mortality after receipt of FFP or liquid plasma of different storage times. METHODS: A cohort of 84,986 Swedish patients was followed up from first recorded allogenic plasma transfusion for 14-day mortality. Associations with exposure to FFP were expressed as relative risks adjusted for patient characteristics, total transfusions, hospital, and calendar year. For non-FFP, the units given to patients who died and matched patients who survived were compared for their duration of storage. RESULTS: The relative risk of exposure to FFP was 1.19 (95% confidence interval: 1.12-1.27, p < 0.0001), with the risk elevation confined to the earlier calendar years of the study. There was no evidence of any effect of storage time of non-FFP. In analyses of all plasma types, FFP from male donors had lowest risk. CONCLUSIONS: Compared with exclusive use of never-frozen plasma, FFP was associated with increased short-term mortality in the era before leukocyte depletion. FFP from female donors had a significantly higher risk than male FFP. For non-FFP, duration of storage was unrelated to mortality. These findings can help to inform policies for managing high plasma demand in critical care. 
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24.
  • Norda, Rut, et al. (författare)
  • Transmission of hepatitis C virus by transfusion in Orebro County, Sweden, 1990-1992
  • 1995
  • Ingår i: Scandinavian Journal of Infectious Diseases. - : Informa UK Limited. - 0036-5548 .- 1651-1980. ; 27:5, s. 449-452
  • Tidskriftsartikel (refereegranskat)abstract
    • A retrospective study of hepatitis C virus (HCV) transmission by transfusion was conducted in Orebro county. Out of the 7,900 active, registered blood donors, 21 repeatedly anti-HCV reactive (RIVA 2 positive or indeterminate) donors were diagnosed. Their 84 recipients from January 1990 through June 1992 were identified and 41 (49%) were alive in December 1992. A total of 13 anti-HCV reactive (RIBA 2 positive or indeterminate) were diagnosed in 39 investigated recipients. Of these 11 were previously undiagnosed, and seven were HCV RNA-positive. In the donor population 1.03% were anti-HCV-positive by ELISA, but only 0.09% were RIBA and HCV RNA-positive. In 1990, 0.06% of the blood components came from the HCV RNA-positive donors, and none during the first 6 months of 1992. In order to identify transfusion-transmitted HCV infections that took place before the introduction of tests for anti-HCV antibodies, patients with a history of transfusion and symptoms and signs of liver dysfunction or damage should be thoroughly tested.
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25.
  • Norda, Rut, et al. (författare)
  • Unexpected effects of donor gender on the storage of liquid plasma
  • 2007
  • Ingår i: Vox Sanguinis. - : Wiley. - 0042-9007 .- 1423-0410. ; 93:3, s. 223-228
  • Tidskriftsartikel (refereegranskat)abstract
    • BACKGROUND: Swedish regulations in effect since 2006 allow the storage of plasma for transfusion up to 14 days at 2-6 degrees C and for 3 years at < or = -30 degrees C. In this study, the quality of currently used plasma components was investigated. MATERIALS AND METHODS: Plasma components, prepared from whole blood or by apheresis, either leucocyte depleted or not leucocyte depleted, were stored at 2-6 degrees C as liquid plasma or as thawed fresh-frozen plasma; 31% were from female donors. Concentration, function and activation markers of the plasma coagulation systems were investigated during storage for up to 42 days. RESULTS: Cold-induced contact activation was the dominant storage lesion, occurring earlier and at higher frequency in plasma from females. Increased kallikrein-like activity led to changes in activated partial thromboplastin time, prothrombin time, protein C and C1 inhibitor (C1INH). C1INH function dropped to 53% on Day 14 in cold-activated plasma components. CONCLUSION: Contact activation may be triggered before Day 14, especially in plasma from females, and may progress as a result of the consumption of C1INH. The data suggest that lack of cold-induced contact activation may be an important quality criterion. To achieve this, plasma from male donors could be selected for transfusion and the storage time limited to 7 days.
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26.
  • Norda, Rut, et al. (författare)
  • Use of plasma : Clinical indications and types of plasma components in Sweden
  • 2007
  • Ingår i: Transfusion Clinique et Biologique. - : Elsevier BV. - 1246-7820 .- 1953-8022. ; 14:6, s. 560-563
  • Tidskriftsartikel (refereegranskat)abstract
    • The use of plasma in Sweden is relatively high compared to other countries in the European Union. An analysis of all transfusion recipients in Orebro county during the whole year 2000 was performed. There were 3159 transfusion recipients of whom 96% had a registered diagnosis and 50% had undergone a "true" operation. Seven hundred and eleven patients (23%) had received plasma. Significantly more operated than nonoperated and more men than women received plasma. The typical plasma recipient was a man undergoing cardiovascular surgery. In Sweden there are two main types of plasma components: fresh frozen (FFP) and nonfrozen liquid plasma stored for up to 14 days, both considered to be clinically equal for most indications. The quality of these components as well as stored thawed FFP has been studied. The major storage effect was cold-induced contact activation and thereby consumption of C1 esterase inhibitor (C1INH) by day 14 in 22%. The citrate content in plasma sustained the overall coagulation function over 14 days. Other studies have shown that the levels of FV and ADAMTS 13 after 14 days remain at 70% or more compared to those for FFP. Since it is immediately available, liquid, nonfrozen or thawed, plasma is of great value in emergencies. Quality criteria for plasma components need to be assessed against evidence based indications and published in guidelines.
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27.
  • Offergeld, R., et al. (författare)
  • Sexual risk behaviour and donor deferral in Europe
  • 2014
  • Ingår i: Vox Sanguinis. - : Wiley. - 0042-9007 .- 1423-0410. ; 107:4, s. 420-427
  • Tidskriftsartikel (refereegranskat)abstract
    • One of the most controversial policies in blood transfusion worldwide is the permanent deferral from donating blood of men with sexual contacts to other men (MSM). This policy was implemented for safety reasons as sex between men is known to be a high risk factor for acquiring severe infectious diseases transmissible by blood transfusion. Sexual contacts among heterosexual persons may hold similar risks but a clear-cut discrimination between different individual risks is impossible. Nevertheless, the current blood donor deferral periods defined by European Union (EU) legislation depend on a distinction of different grades of risk with respect to sexual behaviour. Under the aegis of the Steering Committee on Blood Transfusion (CD-P-TS) of the Council of Europe (CoE), an international working group evaluated epidemiological and behavioural data, modelling studies on residual risk and spread of infections, and studies on adherence to donor selection criteria. The aim was to distinguish sexual behaviour of different risk categories. It was concluded, that existing data confirm that MSM and commercial sex workers (CSW) are groups at high risk. Any further grading lacks a scientific data base. Modelling studies indicate that adherence to deferral policies is of major relevance suggesting that good donor adherence may outweigh the small negative effects on blood safety postulated for changing from permanent to temporary deferral periods for high risk sexual behaviours. The fact that a considerable percentage of donors are MSM - despite the permanent deferral policy - demonstrates the need to increase donor understanding and adherence.
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28.
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29.
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30.
  • Shanwell, A., et al. (författare)
  • Post-transfusion mortality among recipients of ABO-compatible but non-identical plasma
  • 2009
  • Ingår i: Vox Sanguinis. - : Wiley. - 0042-9007 .- 1423-0410. ; 96:4, s. 316-323
  • Tidskriftsartikel (refereegranskat)abstract
    • The consequences of ABO-compatible non-identical plasma for patient outcome have not been studied in randomized clinical trials or large cohort studies and use varies widely in the absence of evidence-based policies. We investigated if transfusion with compatible instead of identical plasma confers any short-term survival disadvantage on the recipients. The cohort of all 86 082 Swedish patients who received their first plasma transfusion between 1990 and 2002 was followed for 14 days and the risk of death in patients exposed to compatible non-identical plasma compared to recipients of only identical plasma. After adjustment for potential confounding factors, there was an increased mortality associated with exposure to ABO-compatible non-identical plasma, with the excess risk mostly confined to those receiving 5 or more units (relative risk, 1.15; 95% confidence interval, 1.02-1.29). Stratification by blood group indicated higher risks in group O recipients, especially when the compatible plasma was from a group AB donor. This study suggests that ABO-compatible non-identical plasma is less safe than identical plasma. Subanalyses by blood group suggest a role for circulating immune complexes. Our findings may have policy implications for improving transfusion safety.
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31.
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32.
  • Stegmayr, Bernd, et al. (författare)
  • World apheresis registry 2003-2007 data
  • 2008
  • Ingår i: Transfusion and apheresis science. - Oxford : Elsevier BV. - 1473-0502 .- 1878-1683. ; 39:3, s. 247-254
  • Tidskriftsartikel (refereegranskat)abstract
    • Objectives: Seventy-five centers from many countries have applied for a login code to the WAA apheresis registry. Fifteen centers from 7 countries have been actively entering data at the internet site from 2003 until 2007. We report on data from the registry so far. Methods: This is a web-based registry. A link is available from the WAA homepage (www.worldapheresis.org). So far data from 2013 patients (12,448 procedures) have been included. A median of 6 treatments have been performed (range 1140). Mean age 51 years (range 1-94 years; 45% women). Seven percent of the patients were <= 21 years and 4% were <= 16 years. Results: The purpose of the apheresis procedure was therapeutic in 67% and retrieval of blood components in 33% Main indications: neurological and hematological diseases, lipid apheresis and stemcell collection (autologous, and some allogeneic). Blood access: peripheral vessels (71%), central dialysis catheter through jugular (6.5%) or subclavian veins (6.7%), femoral vein (8%) and AV fistula (4%). ACD was used for anticoagulation in 73% of the procedures. Albumin was mainly used as replacement fluid. Adverse events (AE) were registered in 5.7% of the procedures. AE was graded as mild (2.5%), moderate (2.7%) or severe (0.5%). No death occurred due to treatment. The procedures were interrupted in 2.6%. Most frequent AEs were blood access problems (29%), tingling around the mouth (20%), hypotension (18%), and urticaria (9%). There were significant differences between the centers regarding mild and moderate AEs. Data indicate that centers using continuous infusion of calcium had fewer AEs. Conclusion: There was a limited number of severe AEs. Centers use various standard procedures for apheresis. By learning from the experience of others the treatment quality will improve further. In the near future, an update of the registry will enable more extensive evaluation of the data.
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33.
  • Tynell, Elsa, et al. (författare)
  • False-reactive microbiologic screening test results in Swedish blood donors - How big is the problem? : A survey among blood centers and deferred donors
  • 2007
  • Ingår i: Transfusion. - : Wiley. - 0041-1132 .- 1537-2995. ; 47:1, s. 80-89
  • Tidskriftsartikel (refereegranskat)abstract
    • BACKGROUND: Screening of blood donors for markers of transfusion-transmissible infectious agents leads to a varying number of false-reactive test results and sometimes thereby temporary or permanent deferral of donors and also to loss of collected units. STUDY DESIGN AND METHODS: Data on false-reactive screening test results in 2002 and 2003 were collected from 19 blood centers in Sweden. A questionnaire was sent to donors deferred because of false-reactive screening test results to investigate their perception of the information and their reaction to the deferral. RESULTS: Testing of 21,189 samples from new donors and 423,543 donations from regular and/or repeat donors produced 1,059 false-reactive test results, mostly from hepatitis C virus antibody testing, and 299 deferrals. Six different human immunodeficiency virus tests led to between 0.02 and 0.2 percent false-reactive results. The deferral rate varied considerably between different counties. Of 204 deferred donors contacted, 180 (88%) answered the questionnaire. More than 80 percent were worried about their test results and worry was more common among those who did not feel sufficiently informed. CONCLUSION: The results imply that there is a need for a more standardized approach to the screening of blood donors and donations with the aim of minimizing the number of false-reactive screening test results. They also emphasize the importance of appropriate information and support to deferred donors.
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34.
  • Tynell, Elsa, et al. (författare)
  • Should plasma from female donors be avoided? : A population-based cohort study of plasma recipients in Sweden from 1990 through 2002
  • 2010
  • Ingår i: Transfusion. - : Wiley. - 0041-1132 .- 1537-2995. ; 50:6, s. 1249-1256
  • Tidskriftsartikel (refereegranskat)abstract
    • BACKGROUND: Plasma from female donors has been implicated in the sometimes fatal complication known as transfusion-related acute lung injury. In studies of patients in intensive care units, worsened gas exchange of the lungs has also been attributed to female plasma. Despite a lack of population-based evidence, policies have already been introduced to exclude female donor plasma. STUDY DESIGN AND METHODS: Short-term mortality after plasma transfusion was investigated using data from the Scandinavian Donations and Transfusions (SCANDAT) database. A cohort of 92,565 patients in 30 Swedish hospitals were followed for 14 days after their first plasma transfusion. The relative risk (RR) of death in recipients of female plasma compared to recipients of only male plasma was estimated from Poisson regression. RESULTS: Recipients had median age 70 years, received a mean of 4.4 plasma units, and had an overall 14-day mortality of 8.43%. Sixty-eight percent were exposed to female plasma, with a 14-day mortality of 8.85% compared to 7.53% in the nonexposed group. After adjustment for potential confounding factors, the RRs were 1.16 (confidence interval [CI], 1.06-1.27) and 1.32 (CI, 1.17-1.49) for those receiving 3 to 4 and 5 or more units of female plasma, respectively. Risk estimates were increased in an analysis of deaths with a concomitant discharge diagnosis involving the respiratory or circulatory system or an adverse reaction. CONCLUSIONS: This large population-based cohort study of unselected patients suggests that transfusion of plasma from female donors confers a short-term survival disadvantage on recipients.
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35.
  • Ullum, Henrik, et al. (författare)
  • Blood donation and blood donor mortality after adjustment for a healthy donor effect
  • 2015
  • Ingår i: Transfusion. - : Wiley. - 0041-1132 .- 1537-2995. ; 55:10, s. 2479-2485
  • Tidskriftsartikel (refereegranskat)abstract
    • BACKGROUND Studies have repeatedly demonstrated that blood donors experience lower mortality than the general population. While this may suggest a beneficial effect of blood donation, it may also reflect the selection of healthy persons into the donor population. To overcome this bias, we investigated the relation between blood donation frequency and mortality within a large cohort of blood donors. In addition, our analyses also took into consideration the effects of presumed health differences linked to donation behavior.STUDY DESIGN AND METHODS Using the Scandinavian Donation and Transfusion database (SCANDAT), we assessed the association between annual number of donations in 5-year windows and donor mortality by means of Poisson regression analysis. The analyses included adjustment for demographic characteristics and for an internal healthy donor effect, estimated among elderly donors exempted from continued donation because of age criteria.RESULTS Statistical analyses included 1,182,495 donors of whom 15,401 died during 9,526,627 person-years of follow-up. Analyses adjusted only for demographic characteristics showed a 18.6% reduction in mortality per additional annual donation (95% confidence interval [CI], 16.8%-20.4%). After additional adjustment for the internal healthy donor effect, each additional annual donation was associated with a 7.5% decreased mortality risk 7.5% (95% CI, 5.7%-9.4%).CONCLUSION We observed an inverse relationship between donation frequency and mortality. The magnitude of the association was reduced after adjustment for an estimate of self-selection in the donor population. Our observations indicate that repeated blood donation is not associated with premature death, but cannot be interpreted as conclusive evidence of a beneficial health effect.
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36.
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37.
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38.
  • Witt, Volker, et al. (författare)
  • World apheresis registry data from 2003 to 2007, the pediatric and adolescent side of the registry
  • 2008
  • Ingår i: Transfusion and apheresis science. - : Elsevier BV. - 1473-0502 .- 1878-1683. ; 39:3, s. 255-260
  • Tidskriftsartikel (refereegranskat)abstract
    • Objectives: Paediatric patients are a special group in apheresis. It is general accepted to use adult indications in paediatric patients, but data in this age group are rare. In order to provide more information of apheresis practise in children and young adults (<21a) we will report of knowledge learnt by data from the registry from 2003 until 2007. Methods: This is a web-based registry. A link is available from the WAA homepage (www.worldapheresis.org). So far data from 12,448 procedures have been included. Six hundred and twelve procedures were performed in 135 children and young adults (308 procedures < 16a, 237 from 17 to 20a, and 67 with 21a) representing 5% of the total population. The median age was 14 years (range 1-21 years), 74 male and 61 female. These data were entered by 15 centres with a frequency of in median 18 aphereses in young patients per centre (range 1-287) from 2003 to 2007. Results: Main indications: haematological diseases and also nephrological, and neurological. The type of aphereses was mainly Leukapheresis (196, 33%), plasma exchange (149, 25%), photopheresis (127, 21%), and lipid aphereses (79, 13%). Blood access: peripheral vessels in 305 procedures (50 K, compared to 73% in adults), central venous catheter in 239 (38%), and AV-fistula in 2% and 0.3%, and in 8 (1.31%) procedures an arterial line was used. Anticoagulation was mostly by ACD (71%), heparin (18% or the combination of both (3%). 39 adverse events (AE) were registered in 22 (=3.59%) of the procedures. mostly graded as mild. Treatment was interrupted in 14 procedures (2.29%. AE's were abdominal pain, anaphylactic shock, flush, hyper- and hypotension, nausea, vertigo, cephalea and need for sedation and technical problems with the device and problems with the venous access. The rate of AE's was similar for stem cell harvesting and for plasma exchange (4%, and 4.7%). respectively). Conclusion: The paediatric data compared to the whole registry data set are showing that aphereses are performed as safe in paediatrics as in adults. Centres are mostly handling only a few cases younger than 21. Therefore more exchange of information and experience in paediatric apheresis is warranted.
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39.
  • Zhao, Jingcheng, et al. (författare)
  • Blood use in hematologic malignancies : a nationwide overview in Sweden between 2000 and 2010
  • 2018
  • Ingår i: Transfusion. - : John Wiley & Sons. - 0041-1132 .- 1537-2995. ; 58:2, s. 390-401
  • Tidskriftsartikel (refereegranskat)abstract
    • BACKGROUNDPatients with hematologic malignancies receive large numbers of blood transfusions, and transfusion practices for this patient group are increasingly being scrutinized by randomized controlled trials. However, no studies so far have presented current transfusion statistics on a population level for this patient group. STUDY DESIGN AND METHODSA retrospective descriptive study was conducted that was based on the Scandinavian Donations and Transfusions Database (SCANDAT2), which includes data on all blood donations and transfusions in Sweden and Denmark since the 1960s. Incident cases of hematologic malignancies were identified in the Swedish Cancer Register between 2000 and 2010. Cases were divided into nine patient groups based on diagnosis. RESULTSA total of 28,693 patients were included in the cohort. Overall, the transfusion pattern varied depending on diagnosis and age. Patients with aggressive and acute diagnoses generally received more transfusions with immediate decline in transfusion incidence after diagnosis, whereas chronic diagnoses generally maintained more stable, but lower, transfusion incidence. In general, patients with leukemia received more transfusions than patients with lymphoma, and patients with acute leukemia as well as patients that had undergone allogeneic stem cell transplantations received the most transfusions. Within 2 years after diagnosis, patients with acute myeloid leukemia diagnosed at ages 0 to 65 years received on average between 30 to 40 red blood cell transfusions and platelet transfusions, respectively, corresponding to direct material costs close to 200,000 SEK (23,809 USD). CONCLUSIONResults from this population-based overview of blood use in hematologic malignancies showed high variability depending on diagnosis and age.
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40.
  • Zhao, Jingcheng, et al. (författare)
  • Frequent platelet donation is associated with lymphopenia and risk of infections : A nationwide cohort study
  • 2021
  • Ingår i: Transfusion. - : John Wiley & Sons. - 0041-1132 .- 1537-2995. ; 61:2, s. 464-473
  • Tidskriftsartikel (refereegranskat)abstract
    • Background: Recently, plateletpheresis donations using a widely used leukoreduction system (LRS) chamber have been associated with T-cell lymphopenia. However, clinical health consequences of plateletpheresis-associated lymphopenia are still unknown.Study Design and Methods: A nationwide cohort study using the SCANDAT3-S database was conducted with all platelet- and plasmapheresis donors in Sweden between 1996 and 2017. A Cox proportional hazards model, using donations as time-dependent exposures, was used to assess the risk of infections associated with plateletpheresis donations using an LRS chamber.Results: A total of 74 408 apheresis donors were included. Among donors with the same donation frequency, plateletpheresis donors using an LRS chamber were at an increased risk of immunosuppression-related infections and common bacterial infections in a dose-dependent manner. While very frequent donors and infections were rare in absolute terms resulting in wide confidence intervals (CIs), the increased risk was significant starting at one-third or less of the allowed donation frequency in a 10-year exposure window, with hazard ratios reaching 10 or more. No plateletpheresis donors that used an LRS chamber experienced a Pneumocystis jirovecii, aspergillus, disseminated mycobacterial, or cryptococcal infection. In a subcohort (n = 42), donations with LRS were associated with low CD4+ T-cell counts (Pearson's R = -0.41; 95% CI, - 0.63 to -0.12).Conclusion: Frequent plateletpheresis donation using an LRS chamber was associated with CD4+ T-cell lymphopenia and an increased risk of infections. These findings suggest a need to monitor T-lymphocyte counts in frequent platelet donors and to conduct future investigations of long-term donor health and for regulators to consider steps to mitigate lymphodepletion in donors.
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