COVID-19 convalescent plasma.

As the coronavirus disease (COVID-19) pandemic led to a global health crisis, there were limited treatment options and no prophylactic therapies for those exposed to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Convalescent plasma is quick to implement, potentially provides benefits, and has a good safety profile. The therapeutic potential of COVID-19 convalescent plasma (CCP) is likely mediated by antibodies through direct viral neutralization and Fc-dependent functions such as a phagocytosis, complement activation, and antibody-dependent cellular cytotoxicity. In the United States, CCP became one of the most common treatments with more than a half million units transfused despite limited efficacy data. More than a dozen randomized trials now demonstrate that CCP does not provide benefit for those hospitalized with moderate to severe disease. However, similar to other passive antibody therapies, CCP is beneficial for early disease when provided to elderly outpatients within 72 hours after symptom onset. Only high-titer CCP should be transfused. CCP should also be considered for immunosuppressed patients with COVID-19. CCP collected in proximity, by time and location, to the patient may be more beneficial because of SARS-CoV-2 variants. Additional randomized trial data are still accruing and should be incorporated with other trial data to optimize CCP indications.

A randomized trial of blood donor iron repletion on red cell quality for transfusion and donor cognition and well-being.

Although altruistic regular blood donors are vital for the blood supply, many become iron deficient from donation-induced iron loss. The effects of blood donation-induced iron deficiency on red cell transfusion quality or donor cognition are unknown. In this double-blind, randomized trial, adult iron-deficient blood donors (n = 79; ferritin < 15 µg/L and zinc protoporphyrin >60 µMol/mol heme) who met donation qualifications were enrolled. A first standard blood donation was followed by the gold-standard measure for red cell storage quality: a 51-chromium posttransfusion red cell recovery study. Donors were then randomized to intravenous iron repletion (1 g low-molecular-weight iron dextran) or placebo. A second donation ∼5 months later was followed by another recovery study. Primary outcome was the within-subject change in posttransfusion recovery. The primary outcome measure of an ancillary study reported here was the National Institutes of Health Toolbox-derived uncorrected standard Cognition Fluid Composite Score. Overall, 983 donors were screened; 110 were iron-deficient, and of these, 39 were randomized to iron repletion and 40 to placebo. Red cell storage quality was unchanged by iron repletion: mean change in posttransfusion recovery was 1.6% (95% confidence interval -0.5 to 3.8) and -0.4% (-2.0 to 1.2) with and without iron, respectively. Iron repletion did not affect any cognition or well-being measures. These data provide evidence that current criteria for blood donation preserve red cell transfusion quality for the recipient and protect adult donors from measurable effects of blood donation-induced iron deficiency on cognition. This trial was registered at www.clinicaltrials.gov as NCT02889133 and NCT02990559.

Local manufacturing processes contribute to variability in human mesenchymal stromal cell expansion while growth media supplements contribute to variability in gene expression and cell function: a Biomedical Excellence for Safer Transfusion (BEST) collaborative study.

BACKGROUND AIMS: Culture-derived mesenchymal stromal cells (MSCs) exhibit variable characteristics when manufactured using different methods, source material and culture media. The purpose of this multicenter study was to assess the impact on MSC expansion, gene expression and other characteristics when different laboratories expanded MSCs from cultures initiated with bone marrow-MSC aliquots derived from the same donor source material yet with different growth media. METHODS: Eight centers expanded MSCs using four human platelet lysate (HPL) and one fetal bovine serum (FBS) products as media supplements. The expanded cells were taken through two passages then assessed for cell count, viability, doubling time, immunophenotype, cell function, immunosuppression and gene expression. Results were analyzed by growth media and by center. RESULTS: Center methodologies varied by their local seeding density, feeding regimen, inoculation density, base media and other growth media features (antibiotics, glutamine, serum). Doubling times were more dependent on center than on media supplements. Two centers had appropriate immunophenotyping showing all MSC cultures were positive for CD105, CD73, CD90 and negative for CD34, CD45, CD14, HLA-DR. MSCs cultured in media supplemented with FBS compared with HPL featured greater T-cell inhibition potential. Gene expression analysis showed greater impact of the type of media supplement (HPL versus FBS) than the manufacturing center. Specifically, nine genes were decreased in expression and six increased when combining the four HPL-grown MSCs versus FBS (false discovery rate [FDR] <0.01), however, without significant difference between different sources of HPL (FDR <0.01). CONCLUSIONS: Local manufacturing process plays a critical role in MSC expansion while growth media may influence function and gene expression. All HPL and FBS products supported cell growth.

Clinical Practice Guidelines From the Association for the Advancement of Blood and Biotherapies (AABB): COVID-19 Convalescent Plasma.

DESCRIPTION: Coronavirus disease 2019 convalescent plasma (CCP) has emerged as a potential treatment of COVID-19. However, meta-analysis data and recommendations are limited. The Association for the Advancement of Blood and Biotherapies (AABB) developed clinical practice guidelines for the appropriate use of CCP. METHODS: These guidelines are based on 2 living systematic reviews of randomized controlled trials (RCTs) evaluating CCP from 1 January 2019 to 26 January 2022. There were 33 RCTs assessing 21 916 participants. The results were summarized using the GRADE (Grading of Recommendations Assessment, Development and Evaluation) method. An expert panel reviewed the data using the GRADE framework to formulate recommendations. RECOMMENDATION 1 (OUTPATIENT): The AABB suggests CCP transfusion in addition to the usual standard of care for outpatients with COVID-19 who are at high risk for disease progression (weak recommendation, moderate-certainty evidence). RECOMMENDATION 2 (INPATIENT): The AABB recommends against CCP transfusion for unselected hospitalized persons with moderate or severe disease (strong recommendation, high-certainty evidence). This recommendation does not apply to immunosuppressed patients or those who lack antibodies against SARS-CoV-2. RECOMMENDATION 3 (INPATIENT): The AABB suggests CCP transfusion in addition to the usual standard of care for hospitalized patients with COVID-19 who do not have SARS-CoV-2 antibodies detected at admission (weak recommendation, low-certainty evidence). RECOMMENDATION 4 (INPATIENT): The AABB suggests CCP transfusion in addition to the usual standard of care for hospitalized patients with COVID-19 and preexisting immunosuppression (weak recommendation, low-certainty evidence). RECOMMENDATION 5 (PROPHYLAXIS): The AABB suggests against prophylactic CCP transfusion for uninfected persons with close contact exposure to a person with COVID-19 (weak recommendation, low-certainty evidence). GOOD CLINICAL PRACTICE STATEMENT: CCP is most effective when transfused with high neutralizing titers to infected patients early after symptom onset.

Blood donation motivators and barriers reported by young, first-time whole blood donors: Examining the association of reported motivators and barriers with subsequent donation behavior and potential sex, race, and ethnic group differences.

BACKGROUND: A greater understanding of young, first-time donor motivators and barriers is needed to address the ongoing challenge of retaining these essential donors. STUDY DESIGN AND METHODS: Structured interviews conducted with 508 young, first-time whole blood donors [66.1% female; Mean Age = 19.4 (SD = 2.5) years] were coded to identify reported motivators and barriers. Reported motivators and barriers were then examined for their association with attempted donation behavior over a 14-month follow-up, and for potential sex, race, and ethnic group differences in the frequency of endorsement. RESULTS: Prosocial motivation (e.g., altruism) was the most commonly reported motivator and fear (e.g., fainting, needles) was the most commonly reported barrier. Donation behavior was unrelated to reported motivators, but was significantly related to four reported barriers including fear of fainting/dizziness, fear of needles/pain, having personal commitments that conflict with donating, and perceiving oneself as unsuited to donate for health reasons. Sex, racial, and ethnic differences were noted with respect to the percentages of donors reporting several donation-related motivators and barriers. CONCLUSION: The present findings identify donation-related barriers that could be important targets to address in the effort to encourage new young donors and to retain these new donors for the long term. Importantly, these data also highlight the importance of considering individual differences in donor motivation as a function of sex, race, and ethnicity.

Access to and safety of COVID-19 convalescent plasma in the United States Expanded Access Program: A national registry study.

BACKGROUND: The United States (US) Expanded Access Program (EAP) to coronavirus disease 2019 (COVID-19) convalescent plasma was initiated in response to the rapid spread of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the causative agent of COVID-19. While randomized clinical trials were in various stages of development and enrollment, there was an urgent need for widespread access to potential therapeutic agents. The objective of this study is to report on the demographic, geographical, and chronological characteristics of patients in the EAP, and key safety metrics following transfusion of COVID-19 convalescent plasma. METHODS AND FINDINGS: Mayo Clinic served as the central institutional review board for all participating facilities, and any US physician could participate as a local physician-principal investigator. Eligible patients were hospitalized, were aged 18 years or older, and had-or were at risk of progression to-severe or life-threatening COVID-19; eligible patients were enrolled through the EAP central website. Blood collection facilities rapidly implemented programs to collect convalescent plasma for hospitalized patients with COVID-19. Demographic and clinical characteristics of all enrolled patients in the EAP were summarized. Temporal patterns in access to COVID-19 convalescent plasma were investigated by comparing daily and weekly changes in EAP enrollment in response to changes in infection rate at the state level. Geographical analyses on access to convalescent plasma included assessing EAP enrollment in all national hospital referral regions, as well as assessing enrollment in metropolitan areas and less populated areas that did not have access to COVID-19 clinical trials. From April 3 to August 23, 2020, 105,717 hospitalized patients with severe or life-threatening COVID-19 were enrolled in the EAP. The majority of patients were 60 years of age or older (57.8%), were male (58.4%), and had overweight or obesity (83.8%). There was substantial inclusion of minorities and underserved populations: 46.4% of patients were of a race other than white, and 37.2% of patients were of Hispanic ethnicity. Chronologically and geographically, increases in the number of both enrollments and transfusions in the EAP closely followed confirmed infections across all 50 states. Nearly all national hospital referral regions enrolled and transfused patients in the EAP, including both in metropolitan and in less populated areas. The incidence of serious adverse events was objectively low (<1%), and the overall crude 30-day mortality rate was 25.2% (95% CI, 25.0% to 25.5%). This registry study was limited by the observational and pragmatic study design that did not include a control or comparator group; thus, the data should not be used to infer definitive treatment effects. CONCLUSIONS: These results suggest that the EAP provided widespread access to COVID-19 convalescent plasma in all 50 states, including for underserved racial and ethnic minority populations. The study design of the EAP may serve as a model for future efforts when broad access to a treatment is needed in response to an emerging infectious disease. TRIAL REGISTRATION: ClinicalTrials.gov NCT#: NCT04338360.

Noninfectious transfusion-associated adverse events and their mitigation strategies.

Blood transfusions are life-saving therapies; however, they can result in adverse events that can be infectious or, more commonly, noninfectious. The most common noninfectious reactions include febrile nonhemolytic transfusion reactions, allergic transfusion reactions, transfusion-associated circulatory overload, transfusion-related acute lung injury, and acute and delayed hemolytic transfusion reactions. These reactions can be asymptomatic, mild, or potentially fatal. There are several new methodologies to diagnose, treat, and prevent these reactions. Hemovigilance systems for monitoring transfusion events have been developed and demonstrated decreases in some adverse events, such as hemolytic transfusion reactions. Now vein-to-vein databases are being created to study the interactions of the donor, product, and patient factors in the role of adverse outcomes. This article reviews the definition, pathophysiology, management, and mitigation strategies, including the role of the donor, product, and patient, of the most common noninfectious transfusion-associated adverse events. Prevention strategies, such as leukoreduction, plasma reduction, additive solutions, and patient blood management programs, are actively being used to enhance transfusion safety. Understanding the incidence, pathophysiology, and current management strategies will help to create innovative products and continually hone in on best transfusion practices that suit individualized patient needs.

Promoting awareness of donation-related iron depletion among high risk blood donors.

BACKGROUND: The potential for iron deficiency is a known blood donor health concern and suggests the need to inform donors about the potential risks of low iron levels as well as strategies to address these risks. STUDY DESIGN AND METHODS: Frequent (n = 904) and young (n = 629) donors were randomly assigned within risk group to either a control (n = 548) or an intervention (n = 985) group. The control group answered questions at baseline and 6-month follow-up regarding their awareness of the risk of donation-related iron depletion and whether they were taking actions to address their iron status. The intervention group answered the same questions at baseline and follow-up, but after completing the baseline survey, they received information regarding their risk of iron depletion and behaviors they could adopt to mitigate this risk. Intervention group participants were also offered the opportunity to develop an action plan to help them supplement their iron intake. RESULTS: The intervention enhanced overall awareness of donation-related iron loss (OR = 1.5, 95% CI 1.171-1.864, p = .001), with no negative impact on retention. Reported iron health behaviors (iron supplementation, speaking with a doctor) showed significant increases when action planning was paired with the educational information. CONCLUSION: These findings suggest that it is possible to increase awareness of donation-related risk for iron depletion without negatively influencing retention, and combining education with encouragement to develop an action plan may increase the likelihood of both retention and behavioral changes to promote healthy iron levels.

Fear is associated with attrition of first-time whole blood donors: A longitudinal examination of donor confidence and attitude as potential mediators.

BACKGROUND: Elevated fear and anxiety regarding donation-related stimuli (e.g., needles, pain, blood, fainting) has been associated with reduced blood donor recruitment and retention. The present longitudinal study tests the notion that this inverse relationship may be accounted for by lower donation confidence and more negative donation attitudes among fearful first-time donors. STUDY DESIGN AND METHODS: In a sample of 1479 first-time whole blood donors [67.9% female; mean age = 19.3 (standard deviation (SD) = 2.5) years], path analyses were conducted to examine relationships among donor ratings of fear of blood draw and donation anxiety obtained approximately 1 week after donation, donation confidence and attitudes assessed approximately 6 weeks later, and donation attempts over the 14 months following the original donation. RESULTS: Path analyses indicated that both fear of blood draws and donation anxiety were associated with fewer attempted donations, and that these effects were indirectly mediated by a combination of lower donor confidence and more negative donation attitudes. CONCLUSION: Because retention of new blood donors is essential to maintain a healthy blood supply, the results of the present study suggest that first-time donors should be assessed for fear and anxiety so that appropriate strategies can be provided to address their concerns, bolster their confidence and attitudes, and ultimately promote their long-term retention.

Results from the blood donor competence, autonomy, and relatedness enhancement (blood donor CARE) randomized trial.

BACKGROUND: This study aimed to promote competence, autonomy, and relatedness among first-time whole blood donors to enhance intrinsic motivation and increase retention. STUDY DESIGN AND METHODS: Using a full factorial design, first-time donors (N = 2002) were randomly assigned to a no-treatment control condition or to one of seven intervention conditions designed to promote donation competence, autonomy, relatedness, a combination of two (e.g., competence and autonomy), or all three constructs. Participants completed donor motivation measures before the intervention and 6 weeks later, and subsequent donation attempts were assessed for 1 year. RESULTS: There was no significant group difference in the frequency of donation attempts or in the number of days to return. Significant effects of group were observed for 10 of the 12 motivation measures, although follow-up analyses revealed significant differences from the control group were restricted to interventions that included an autonomy component. Path analyses confirmed direct associations between interventions involving autonomy and donor motivation, and indirect mediation of donation attempts via stronger donation intentions and lower donation anxiety. CONCLUSION: Among young, first-time, whole blood donors, brief interventions that include support for donor autonomy were associated with direct effects on donor motivation and indirect, but small, effects on subsequent donation behavior.

Blood transfusions in gunshot-wound-related emergency department visits and hospitalizations in the United States.

BACKGROUND: The United States (US) leads all high-income countries in gunshot wound (GSW) deaths. However, previous US studies have not evaluated the national blood transfusion utilization patterns in hospitalized GSW patients. METHODS: Data from 2016 to 2017 were analyzed from the Nationwide Emergency Department Sample (NEDS) and Nationwide Inpatient Sample (NIS), the largest all-payer emergency department (ED) and inpatient databases, respectively. Using stratified probability sampling, weights were applied to generate nationally representative estimates. Multivariable Poisson-regression models were used to estimate prevalence ratios (PR) of blood transfusion. RESULTS: There were 168,315 ED visits and 58,815 hospitalizations (age = 18-90 years) following a GSW. The majority of hospitalizations were men (88.5%), age 18-24 years (31.8%), and assault-related GSW (51.3%). Blacks had the largest proportion (48.7%) overall of all GSW hospitalizations; Whites accounted for the highest proportion of intentional self-harm injuries (72.4%). Blood transfusions occurred in 12.7% of hospitalizations (12.0% red blood cell [RBC], 4.9% plasma, and 2.5% platelet transfusions). Only 1.9% of cases were associated with transfusion of all three blood components. Hospitalizations with major/extreme severity of illness had significantly higher prevalence of transfusion versus those with mild/moderate severity [crude PR = 4.79 (95%CI:4.15-5.33, p < .001)]. Overall, 8.2% of hospitalizations with GSW died, of whom 26.8% required blood transfusions, which was significantly higher than survivors [crude PR = 2.34 (95%CI:2.10-2.61, p < .001)]. The vast majority (95%) of the transfusions among those who died were within 48 h since admission. CONCLUSIONS: Gun-related violence is a public health emergency in the US, and GSWs are a source of significant mortality, blood utilization, and health care costs.

Transfusion reactions associated with COVID-19 convalescent plasma therapy for SARS-CoV-2.

BACKGROUND: Convalescent plasma (CP) for treatment of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has shown preliminary signs of effectiveness in moderate to severely ill patients in reducing mortality. While studies have demonstrated a low risk of serious adverse events, the comprehensive incidence and nature of the spectrum of transfusion reactions to CP is unknown. We retrospectively examined 427 adult inpatient CP transfusions to determine incidence and types of reactions, as well as clinical parameters and risk factors associated with transfusion reactions. STUDY DESIGN AND METHODS: Retrospective analysis was performed for 427 transfusions to 215 adult patients with coronavirus 2019 (COVID-19) within the Mount Sinai Health System, through the US Food and Drug Administration emergency investigational new drug and the Mayo Clinic Expanded Access Protocol to Convalescent Plasma approval pathways. Transfusions were blindly evaluated by two reviewers and adjudicated by a third reviewer in discordant cases. Patient demographics and clinical and laboratory parameters were compared and analyzed. RESULTS: Fifty-five reactions from 427 transfusions were identified (12.9% incidence), and 13 were attributed to transfusion (3.1% incidence). Reactions were classified as underlying COVID-19 (76%), febrile nonhemolytic (10.9%), transfusion-associated circulatory overload (9.1%), and allergic (1.8%) and hypotensive (1.8%) reactions. Statistical analysis identified increased transfusion reaction risk for ABO blood group B or Sequential Organ Failure Assessment scores of 12 to 13, and decreased risk within the age group of 80 to 89 years. CONCLUSION: Our findings support the use of CP as a safe, therapeutic option from a transfusion reaction perspective, in the setting of COVID-19. Further studies are needed to confirm the clinical significance of ABO group B, age, and predisposing disease severity in the incidence of transfusion reaction events.

Zika virus and its implications on cord blood banking and transplantation.

Umbilical cord blood is an important cellular therapy product used for hematopoietic stem cell transplantation, but the US Food and Drug Administration guidance regarding donor screening to reduce the risk of Zika transmission has decreased the number of licensed, eligible cord blood units available for transplantation. There is a crucial need for updated travel risk assessment for Zika virus transmission, validated screening tests for Zika virus in umbilical cord blood, and further research on Zika virus transmissibility due to umbilical cord blood products to ensure that umbilical cord blood and related tissues are safe and available for transplantation.

Examination of the relationship between iron status and cognitive function among healthy young women with and without a recent history of blood donation.

BACKGROUND: With growing awareness of the prevalence of nonanemic iron deficiency among blood donors, there is a need to explore the extent of potential negative consequences. This study examined the relationship between various measures of iron status, blood donation history, and neuropsychological and psychosocial functioning in healthy young women. STUDY DESIGN AND METHODS: Using a cross-sectional design, 160 female undergraduates completed neuropsychology tests and measures of sleep, fatigue, quality of life, and depression before providing a blood sample. Correlational analyses examined the relationship between iron status (ferritin, iron, hemoglobin, and zinc protoporphyrin) and cognitive and psychosocial functioning. Performance on these measures was also examined as a function of recent blood donation history (zero, one, more than one donation in the past year). RESULTS: Iron status (low ferritin, iron, or hemoglobin or high zinc protoporphyrin) was not associated with poorer performance on the cognitive tasks. Further, participants who reported donating once in the previous year performed better, rather than worse, than those with no recent donation history on several measures of executive function, even when controlling for ferritin levels. Although there was some evidence of greater fatigue among those who had donated more than once in the past year, this effect was not accounted for by ferritin levels. CONCLUSION: The present findings are consistent with prior evidence that nonanemic iron deficiency is not associated with cognitive impairment or psychosocial dysfunction in healthy young females. Because these results are based on cross-sectional evidence, further study using longitudinal research is needed to confirm these findings.

How did we rapidly implement a convalescent plasma program?

Since the beginning of the COVID-19 pandemic, the use of convalescent plasma as a possible treatment has been explored. Here we describe our experience as the first U.S. organization creating a COVID-19 convalescent plasma program to support its use through the single-patient emergency investigational new drug, the National Expanded Access Program, and multiple randomized controlled trials. Within weeks, we were able to distribute more than 8000 products, scale up collections to more than 4000 units per week, meet hospital demand, and support randomized controlled trials to evaluate the efficacy of convalescent plasma treatment. This was through strategic planning; redeployment of staff; and active engagement of hospital, community, and public health partners. Our partners helped with donor recruitment, testing, patient advocacy, and patient availability. The program will continue to evolve as we learn more about optimizing the product. Remaining issues to be resolved are antibody titers, dose, and at what stage of disease to transfuse.

Use of a rapid electronic survey methodology to estimate blood donors' potential exposure to emerging infectious diseases: Application of a statistically representative sampling methodology to assess risk in US blood centers.

Risk assessments of transfusion-transmitted emerging infectious diseases (EIDs) are complicated by the fact that blood donors' demographics and behaviors can be different from the general population. Therefore, when assessing potential blood donor exposure to EIDs, the use of general population characteristics, such as U.S. travel statistics, may invoke uncertainties that result in inaccurate estimates of blood donor exposure. This may, in turn, lead to the creation of donor deferral policies that do not match actual risk. STUDY DESIGN AND METHODS: This article reports on the development of a system to rapidly assess EID risks for a nationally representative portion of the U.S. blood donor population. To assess the effectiveness of this system, a test survey was developed and deployed to a statistically representative sample frame of blood donors from five blood collecting organizations. Donors were directed to an online survey to ascertain their recent travel and potential exposure to Middle East respiratory syndrome coronavirus (MERS-CoV). RESULTS: A total of 7128 responses were received from 54 256 invitations. The age-adjusted estimated total number of blood donors potentially exposed to MERS-CoV was approximately 15 640 blood donors compared to a lower U.S. general population-based estimate of 9610 blood donors. CONCLUSION: The structured donor demographic sample-based data provided an assessment of blood donors' potential exposure to an emerging pathogen that was 63% larger than the U.S. population-based estimate. This illustrates the need for tailored blood donor-based EID risk assessments that provide more specific demographic risk intelligence and can inform appropriate regulatory decision making.

Donor incentives improve cardiovascular disease risk profile and donation rates.

BACKGROUND: Blood centers may offer point-based reward systems or cardiovascular disease (CVD) screening to incentivize donors. However, combining these incentives to improve CVD risk and blood donation rates has not been studied. STUDY DESIGN AND METHODS: Study was a three-arm prospective controlled trial: Group 1, control (routine points, no CVD screening); Group 2, CVD screening with routine points; and Group 3, CVD screening plus incentive double points. The primary objective was to determine if double versus routine incentive points led to improvement or maintenance of CVD risk profile assessed using self-reported changes in 1) reading food labels for calorie and fat content, 2) exercising daily, 3) reduced fat intake, and 4) increase in eating fruits and vegetables. Outcomes were compared at first and final (2-year) follow-up visits. As secondary outcome, median blood donation rates before enrollment and during study were compared. RESULTS: A total of 570 donors (290 in Group 1, 134 in Group 2, 146 Group 3) were selected. At first follow-up visit, 71.4% in Group 3 versus 62.0% in Group 2 subjects reported at least one of four positive behavioral changes (p < 0.001). Increase in reading food labels for calorie and fat content was the most common change and higher in Group 3 (Group 3 from 60.9% to 79.1%; Group 2 from 67.6% to 77.5%; p < 0.001). Final evaluation showed significant increase in self-reported exercise in Group 3 only (from baseline 52.9% to 68.3%; p < 0.05). Group 3 reported higher increase in median number of donations/year during study enrollment (6.8 [IQR, 4.3-12] vs. baseline 4.6 [IQR, 3.2-7.1] donations/year) than Group 2 (5.6 [IQR, 4.2-10.5] vs. baseline 4.9 [IQR, 3.5-10.2]) and Group 1 (4.4 [IQR, 2.7-8.0] vs. baseline 4.4 [IQR, 2.5-6.0] donations/year; p < 0.001). CONCLUSION: Positive donor reinforcement (double vs. routine points) resulted in better self-reported health maintenance behavior and increased donation rates.

Ten years of TRALI mitigation: measuring our progress.

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

Factors associated with red blood cell, platelet, and plasma transfusions among inpatient hospitalizations: a nationally representative study in the United States.

BACKGROUND: Demographic and hospital-level factors associated with red blood cell (RBC), plasma, and platelet transfusions in hospitalized patients across the U.S. are not well characterized. METHODS: We conducted a retrospective analysis of the National Inpatient Sample (2014). The unit of analysis was a hospitalization; sampling weights were applied to generate nationally-representative estimates. The primary outcome was having ≥ 1 RBC transfusion procedure; plasma and platelet transfusions were similarly assessed as secondary outcomes. For each component, factors associated with transfusion were measured using adjusted prevalence ratios (adjPR) and 95% confidence intervals (95% CI) estimated by multivariable Poisson regression. RESULTS: The prevalence of RBC, plasma, and platelet transfusion was 5.8%, 0.9%, and 0.7%, respectively. RBC transfusions were associated with older age (≥ 65 vs. < 18 years; adjPR = 1.80; 95% CI = 1.66-1.96), female sex (adjPR = 1.13; 95% CI = 1.12-1.14), minority race/ethnic status, and hospitalizations in rural hospitals compared to urban teaching hospitals. Prevalence of RBC transfusion was lower among hospitalizations in the Midwest compared to the Northeast (adjPR = 0.73; 95% CI = 0.67-0.80). All components were more likely to be transfused in patients with a primary hematologic diagnosis, patients with a higher number of total diagnoses, patients who experienced a higher number of other procedures, and patients who eventually died in the hospital. In contrast to RBC transfusions, prevalence of platelet transfusion was greater in urban teaching hospitals (vs. rural; adjPR = 1.71; 95% CI = 1.49-1.98) and lower in blacks (vs. whites; adjPR = 0.80; 95% CI = 0.76-0.85). CONCLUSIONS: Nationally, there is heterogeneity in factors associated with transfusion between each blood component, including by hospital type and location. This variability presents patient blood management programs with potential opportunities to reduce transfusions.

An automated motivational interview promotes donation intention and self-efficacy among experienced whole blood donors.

BACKGROUND: Interventions intended to motivate donors to return can be costly and time consuming. The current study examined the effect of a Web-based automated interview, informed by motivational interviewing and self-determination theory, on donor intention, motivation, and behavior in a sample of highly experienced donors. STUDY DESIGN AND METHODS: Approximately 1 week after donating, 1177 highly experienced whole blood donors (mean prior donations, 35.5; mean age, 46.9 years; 66.3% female) participated in a study in which they were randomly assigned to either a donor motivational interview (n = 544) or knowledge interview (n = 633). Measures of donor motivation and psychological need support were obtained before the interviews, and again at postinterview assessments conducted approximately 2 days later and 7 weeks later. Blood center records were used to assess repeat donation attempts for 1 year after the interviews. RESULTS: Relative to the knowledge interview, participants in the motivational interview had larger increases in donation intention and self-efficacy from preinterview to the first follow-up. Among women only, the motivational interview was associated with greater competence and relatedness increases at both follow-up assessments. CONCLUSION: An automated motivational interview appears to be a feasible way to promote donation intention and self-efficacy. Although the observed effects were small among highly experienced donors, we are currently assessing the potential effect of this intervention among less experienced donors.