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BACKGROUND Source plasma (SP) is the primary starting material for 87% of plasma-derived medicinal products globally. Plasmavigilance is a program designed to collect, analyze, and monitor donor adverse events (AEs) across the SP collection industry. Donor retention depends on donors having a safe and satisfactory experience. This study analyzes AE rates and SP donor characteristics that may be predictors of an AE. STUDY DESIGN AND METHODS Donation data for 1.1 million donors making 12,183,182 SP donations over a 4-month period were analyzed. This represented approximately 72% of the donations collected by the U.S. plasma industry. The Standard for Recording Donor Adverse Events was used for AE definitions and classifications. RESULTS The overall AE rate was 15.85/104 donations. The two AEs with the highest rates were Hypotensive and Phlebotomy events (8.32 and 5.91/104 donations, respectively). Females had higher overall AE rates than males (25.76 vs. 9.85/104 donations), and first-time donors had higher overall AE rates than repeat donors (136.66 vs. 12.37/104 donations). Weight, body mass index, age, and pre-donation estimated blood volume also were predictors of AE. DISCUSSION SP donors have low AE rates with 90% being events classified as Hypotensive or Phlebotomy. Special attention and mitigation strategies should be directed to donors who are young, lightweight (between 100 and 124 pounds), female, or first-time donors to further reduce the incidence of AE, continue to ensure the donor has a safe experience, and facilitate donor retention.

Background Although the safety and therapeutic efficacy of COVID‐19 convalescent plasma (CCP) has been extensively evaluated, the safety of CCP donation has not been explored in a multi‐institutional context. Study design and methods Nine blood collection organizations (BCOs) participated in a multi‐institutional donor hemovigilance effort to assess the safety of CCP donation. Donor adverse events (DAEs) were defined according to the Standard for Surveillance of Complications Related to Blood Donation, and severity was assessed using the severity grading tool. Multivariate analysis was performed to determine attributes associated with DAE severity. Results The overall DAE rate was 37.7 per 1000 donations. Repeat apheresis and apheresis‐naïve donors experienced adverse event rates of 19.9 and 49.8 per 1000 donations, respectively. Female donors contributed 51.9% of CCP donations with a DAE rate of 49.4 per 1000 donations. The DAE rate for male donors was 27.4 per 1000 donations. Vasovagal reactions accounted for over half of all reported DAEs (51.1%). After adjustment, volume of CCP donated was associated with vasovagal reaction severity (odds ratio [OR] 6.5, 95% confidence interval [CI] 2.5–17.1). Donor age and donation history were also associated with DAE severity. Considerable differences in DAE types and rates were observed across the participating BCOs despite the use of standardized hemovigilance definitions. Conclusion The safety of CCP donation appears comparable to that of conventional apheresis plasma donation with similar associated risk factors for DAE types and severity.

Background Whole blood and red blood cell (RBC) donors are at risk of iron deficiency. Since Source plasma (SP) donors have RBCs returned during apheresis, risk of iron depletion appears low. However, SP donors can donate frequently and assessment of frequent donor iron status is needed. Study design and methods A total of 1254 SP donors were enrolled in four frequency groups determined by donations in the prior 12 months: no donations and 1 to 24, 25 to 69, and 70 or more donations. Ferritin was determined for each donor. Donors with ferritin levels of less than 12 ng/mL were classified as having absent iron stores (AIS). Results Compared to new donors, ferritin for females was higher in each successive frequency group. For 70 or more donations, ferritin was 13 ng/mL higher than in new donors (p = 0.02). For males, 1 to 24 donations had the highest ferritin levels. Compared to new donors, highest-frequency donors had lower ferritin levels, 114 ng/mL versus 100 ng/mL (p = 0.14). Age for females and males increased with each successive frequency group. Age adjustment resulted in smaller ferritin differences for females and larger differences for males in the high-frequency groups; AIS for females was highest in new donors (7%) and lowest in the highest-frequency group (1%). In aggregate, AIS occurred in less than 1% of all male donors. Male new and highest-frequency donors had 1% AIS with none in the other groups. Conclusion Few SP donors have iron depletion and it is not higher in frequent donors. Frequent SP donation does not adversely impact iron stores. Thus, monitoring donor iron status or iron supplementation is not necessary.

BACKGROUND Objectives of this study were to identify possible patient and product risk factors for intravenous immune globulin (IVIG)-associated hemolysis, a recognized side effect of IG therapy; analyze IVIG indications; and examine dose levels (g/kg body weight) and total IVIG dose administered. STUDY DESIGN AND METHODS Reports of IVIG-associated hemolysis for 10 years (2003-2012) for four participating IG manufacturers were identified using a uniform case definition (Standardized MedDRA Query “Hemolytic disorders,” Broad Scope, Version 16.0) and analyzed. RESULTS IVIG-associated hemolysis appears to occur predominantly at dose levels exceeding 0.5 g/kg, with 72% of cases with known dose information having dose levels between 1 and 2.5, and can affect patients at any age, without a clear gender preference. No association was found between hemagglutinin exposure and development of hemolysis, nor between dose levels and odds of receiving a transfusion to treat hemolysis. Patients with blood group AB may be at higher risk of hemolysis than those with group A or B. CONCLUSION Data examined confirm that IVIG-associated hemolysis predominantly occurs following infusion of high IVIG doses, and can affect patients at every age of both genders. While presence of hemagglutinins appears to play a major role in pathogenesis of hemolytic disorders, high hemagglutinin titers of IVIG products themselves seem to be of less relevance, indicating that the pathomechanism of IVIG-associated hemolysis may be related to the presence, but not the absolute amount, of hemagglutinins. Patients with hemolysis had additional hemolytic risks such as multiple comorbidities and medication use. IG-treated patients with multiple risks should be closely monitored for hemolysis.

Whole blood and red blood cell (RBC) donors are at risk of iron deficiency. Since Source plasma (SP) donors have RBCs returned during apheresis, risk of iron depletion appears low. However, SP donors can donate frequently and assessment of frequent donor iron status is needed.A total of 1254 SP donors were enrolled in four frequency groups determined by donations in the prior 12 months: no donations and 1 to 24, 25 to 69, and 70 or more donations. Ferritin was determined for each donor. Donors with ferritin levels of less than 12 ng/mL were classified as having absent iron stores (AIS).Compared to new donors, ferritin for females was higher in each successive frequency group. For 70 or more donations, ferritin was 13 ng/mL higher than in new donors (p = 0.02). For males, 1 to 24 donations had the highest ferritin levels. Compared to new donors, highest-frequency donors had lower ferritin levels, 114 ng/mL versus 100 ng/mL (p = 0.14). Age for females and males increased with each successive frequency group. Age adjustment resulted in smaller ferritin differences for females and larger differences for males in the high-frequency groups; AIS for females was highest in new donors (7%) and lowest in the highest-frequency group (1%). In aggregate, AIS occurred in less than 1% of all male donors. Male new and highest-frequency donors had 1% AIS with none in the other groups.Few SP donors have iron depletion and it is not higher in frequent donors. Frequent SP donation does not adversely impact iron stores. Thus, monitoring donor iron status or iron supplementation is not necessary.

BACKGROUND Evans syndrome is a rare condition manifested by combined autoimmune hemolytic anemia (AIHA) and thrombocytopenia or neutropenia. It is often associated with other autoimmune disorders, immunodeficiencies, and non-Hodgkin’s lymphoma.

Background Lack of ready access to a donation site may be a potential barrier to or influence the frequency of blood donations. In this study, we applied geographic analysis to blood donor behavior and use of different donation sites. Study Design and Methods The study population consisted of blood donors who gave whole blood in Georgia between 2004 and 2008. Zip code, city, and county of donor's residence were matched with the addresses of their donation sites. Donors were dichotomized as either nonmetro Atlanta or metro Atlanta residents. Six donation site categories were defined: donation within the same or a different zip code, within the same or a different city, and within the same or a different county. Logistic regression was used to compare donations by zip code, city, and county. Results The study population consisted of 402,692 blood donors who donated 1,147,442 whole blood units between 2004 and 2008, more than half of whom (56.4%) resided in the metro Atlanta area. The majority of donors were white (75.0%) and female (55.7%). In nonmetro Atlanta, repeat donors were more likely to have donated at fixed sites (p

BACKGROUND: Misperceptions about the risk of contracting AIDS from donating blood may be preventing people from donating, while incorrect beliefs about AIDS screening tests or the appropriateness of donating with risk factors may place the blood supply at increased risk. STUDY DESIGN AND METHODS: Questions about AIDS transmission and testing and the acceptability of test seeking and donating with risk factors were asked in the National Community Health Survey, a telephone survey of 9859 US adults. Results were weighted to represent the US population. Demographic and donor status (current, lapsed, never) differences in knowledge and attitudes were examined using chi-square and logistic regression. RESULTS: Nearly 25% of respondents thought it was somewhat or very likely that they could get AIDS from donating blood. Almost 80% knew that all blood donations are tested for AIDS, but only 65.5% knew about the test window period. A total of 33.5% felt that it was acceptable to use the blood center for AIDS testing, while 9.1% believed that it was okay for someone to donate even if they had AIDS risk behaviors; all had significant demographic and donor status differences. CONCLUSIONS: While there are many factors that prevent people from giving blood, the incorrect belief that it is possible to contract AIDS from donating is likely a barrier to donation. If blood centers dispelled this myth among those who have never donated, especially among minorities, it could be important for recruitment. In addition, our findings indicate that changes to education or recruitment could be needed to discourage test seeking and donations from risky donors.

BACKGROUND: Historically, African Americans have a general mistrust for the health care system that has contributed to significant health disparities. The goal of this study was to evaluate whether this distrust among African Americans affects attitudes toward blood donation. STUDY DESIGN AND METHODS: Fifteen African American churches in metropolitan Atlanta participated in an 81-item self-administered survey. The questionnaire assessed barriers and motivators for, and knowledge and beliefs about, blood donation in African Americans. Bivariate analysis and logistic regression models were performed. RESULTS: A total of 930 individuals responded to the survey. This group was 99% African Americans, 71% female, and 84% college educated, 54% with a household income of at least $50,000 and mean age of 47 ± 14 years. Donation history was 3% current donors, 46% lapsed donors, and 40% nondonors. Respondents who trusted versus distrusted hospitals had more knowledge of the blood supply and less fear of donation and were more likely to respond to blood needs of the community. In a multivariate logistic regression model, donors were more likely to trust hospitals (p = 0.003) and were more likely to have participated in research (p

BACKGROUND: In China recruitment and retention of sufficient numbers of safe blood donors continues to be a challenge. Understanding who donates blood, particularly those who donate larger (>200 mL) whole blood (WB) units, will help blood centers to target more effective recruitment and retention strategies. STUDY DESIGN AND METHODS: Demographic characteristics of 226,489 allogeneic WB donors from January to December 2008 at five geographically and ethnically diverse, urban blood centers were analyzed. RESULTS: The typical Chinese WB donor can be characterized as first-time volunteer (67.9%), male (56.9%), less than 45 years old (93.8%), and Han ethnicity (86.1%). Most donors had some college or below educational level (77.5%), donated at a mobile collection site (97.6%), and donated 300- or 400-mL units (76.0%). Differences in WB volume donations and donor demographics exist among the five centers. CONCLUSION: In China compared to the United States, donations are made by younger donors and donors give infrequently and make smaller WB donations. To help ensure supply adequacy, continued efforts are needed to have donors give larger volumes of WB in China.

To ensure an adequate blood supply, it is crucial to recruit suitable blood donors. These are ideally individuals with low risk for infectious diseases, who are in good health, and willing to spend their time to help someone out of a sense of solidarity and altruism. Prior to the late 1970s and early 1980s, blood collections in Brazil were mainly performed by private blood banks. Cash reimbursement for donation was a common practice, and there were few laws regulating blood bank activities. An assessment performed for the Brazilian Ministry of Health Blood by the World Health Organization (WHO) in early 1970s documented serious problems with the blood banking policies and practices1, which led the federal government to define blood safety as a national security problem. Measures were taken to improve the safety and quality of blood and components, especially after the onset of the AIDS epidemic, when blood transfusion practices became an important political issue.2,3 The Brazilian network of public blood centers was created in the late 1970s and early 1980s, as a response to these blood safety concerns. Although the centers were under the state administrations, federal funds were allocated to support these public blood centers and cooperation with the French government made it possible to train a large number of professionals in blood collection and processing and transfusion practices. Blood transfusion is now regulated by the Federal Government through Anvisa, the national health surveillance agency, and by the Blood Coordination Office in the Ministry of Health which is responsible for the policies of the system. Specific methodologies are defined for donor recruitment, deferral criteria, laboratory tests, cold chain, and related component preparation procedures2. The regulations are very similar to those in place in the US and Europe, and internationally accepted procedures and guidelines are used as reference in the development of Brazilian rules and practice guidelines.1 In addition to establishing “sanitary policies” regarding donor selection, blood testing and handling of blood products, paid blood donations were forbidden.2 The prohibition from paid donations could have had an enormous impact on the blood supply due to the lack of experience of centers in recruiting voluntary blood donors. General concern that this prohibition would dramatically decrease blood availability led Brazilian blood centers to rapidly develop programs to recruit donors among friends and relatives of hospitalized patients, termed “replacement donors”. This procedure had the effect of maintaining the blood supply, following the sudden reduction in collections due to the elimination of paid blood donors, and replacement donors became the major source of blood units in Brazil in the 1980s. One of the main problems in relying on this type of donor is that most of them are first-time blood donors, so the prevalence of infectious disease markers is higher3,4,5, leading to an elevated percentage of discarded units and greater risk of a window-period donation. In addition, families and friends of patients were frequently “asked” to donate in a forceful way. Replacement donations, solicited prior to medical procedures, with numbers determined by the hospitals/procedures, were compulsory before the patient would be treated or undergo surgery. This led to an undesirable situation, where, in the quest for blood donors, the patients and/or their families would recruit potential donors at the entrances of blood banks to donate in the name of a specific donor, sometimes offering to pay these unrelated individuals for blood donation. Hence, some donors were still paid, although not by the blood bank. Recognizing the inherent problem with these practices, concerted efforts were made during the 1990’s to change the blood donor supply from replacement first-time donors to community voluntary repeat donors. However, still today, replacement donors are responsible for up to 50% of blood donations in many regions of Brazil.2 It is estimated that 3 million units of blood are collected per year in Brazil, with approximately 70% of donations in these regions collected through the public system.1,2 However, national studies on blood donation are scarce in Brazil. Data on blood donation and use is now compiled, in a semi-manual way, at the federal level by Anvisa and by the Blood Coordination Office, but these data are usually incomplete and outdated.1,2 Although blood donor systems in Brazil are required by law to store their donor/and donation data, they have been unable to combine data from multiple centers or systematically analyze these data due to lack of computer database systems with the capacity to create and analyze large datasets. The NHLBI International REDS-II study in Brazil started in 2007, and is comprised of three major public blood banks. Two of them are in the Southeast region of Brazil6, where most of the blood is collected, while the third is in Northeastern coastal Brazil. There are considerable regional differences between the Southeastern and Northeastern parts of Brazil7, and differences in blood donor profile and behavior were expected. The present work describes the demographic profile of blood donors in the three centers, how it compares with the general population of the cities where each center is located, and discusses strategies to increase the proportion of the general population that donates blood in Brazil.

Author(s): Murphy, Edward L; Shaz, Beth; Hillyer, Christopher D; Carey, Patricia; Custer, Brian S; Hirschler, Nora; Fang, Junyong; Schreiber, George B; NHLBI Retrovirus Epidemiology in Blood Donors Study-II (REDS-II) | Abstract: BackgroundHistorically, minority populations have represented only a small proportion of US blood donors, but recent trends in immigration and potential blood shortages emphasize the need for recruitment strategies to increase minority donations.Study design and methodsDonation data from a network of six US blood centers for 2006 were analyzed. Race/ethnicity, country of birth, and educational attainment data were collected specifically for the study and assessed for their influence on donation behavior. Logistic regression was used to determine independent associations with repeat donors status and annual donation frequency.ResultsA total of 1,288,998 donations from 729,068 donors were studied; most donors had data on race/ethnicity (97.1%) and country of birth (93.1%). The proportion of minority donors differed by blood center, with African American donors (16%) most common at the Southeastern blood center and Asian (12%), Hispanic (13%), and foreign-born donors (13%) most common at the Northern California blood center. Minority donors and those born in Mexico or Latin America were younger than white donors. Minority and non-US-born donors were less likely than white and US-born donors to be repeat donors (odds ratio [OR], 0.60-0.78), and most were less likely to give two or more annual donations (OR, 0.82-1.11).ConclusionMinority and Mexico/Latin America-born donors represent a younger and often first-time donor population compared to white and US-born donors, but their annual donation frequency was only slightly lower than white and US-born donors. Increasing the retention and donation frequency of minorities will be important for supplementing the blood supply.

BACKGROUND: Antibodies to human leukocyte antigens (HLA) in donated blood have been implicated as a cause of transfusion-related acute lung injury (TRALI). A potential measure to reduce the risk of TRALI includes screening plateletpheresis donors for HLA antibodies. The prevalence of HLA antibodies and their relationship to previous transfusion or pregnancy in blood donors was determined. STUDY DESIGN AND METHODS: A total of 8171 volunteer blood donors were prospectively recruited by six US blood centers from December 2006 to May 2007. Donors provided a detailed history of pregnancy and transfusion and a sample for HLA Class I and II antibody testing by multiantigen bead flow analysis. RESULTS: A total of 8171 donors were enrolled; 7920 (96.9%) had valid HLA antibody test results and 7841 (99%) of those had complete pregnancy and transfusion information. The prevalence of any HLA antibody was similar in nontransfused (n = 1138) and transfused (n = 895) men, 1.0% versus 1.7% (p = 0.16). HLA antibodies were detected in 17.3% of all female donors (n = 5834) and in 24.4% of those with a history of previous pregnancy (n = 3992). The prevalence of HLA antibodies increased in women with greater numbers of pregnancy: 1.7% (zero), 11.2% (one), 22.5% (two), 27.5% (three), and 32.2% (four or more pregnancies; p < 0.0001). CONCLUSION: HLA Class I and Class II antibodies are detectable at low prevalence in male donors regardless of transfusion and in female donors without known immunizing events. The prevalence of HLA antibodies increases significantly with more pregnancies. These data will allow blood centers to estimate the impact of HLA antibody testing as a potential TRALI risk reduction measure.