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.

Retrospective analysis of community hospital red blood cell recovery procedures: improved utilization needed for effectiveness.

BACKGROUND: Perioperative blood recovery (PBR) is an important component of patient blood management. We analyzed our experience providing PBR for community hospitals to determine procedure types and clinical variables associated with efficacy and cost-effectiveness. STUDY DESIGN AND METHODS: PBR cases (>25,000) from January 2008 through December 2012 were analyzed. For each procedure type, the median number of returned red blood cell units (rRBCs) and ratio of cases with at least 1 to less than 1 rRBC unit were calculated. Clinical predictors of rRBC were identified by linear and logistic regression. RESULTS: The overall median rRBC was 0.29 units despite median estimated blood loss (EBL) of 350 mL. Only three of 31 common procedure types had ≥1:<1 rRBC ratios near to or higher than 1. In nine of 31 common procedure types, at least 50% of cases had no rRBC return. Linear regression demonstrated significant association of rRBCs with increased EBL, longer operative duration, surgeon, PBR device type (autoLog vs. CS5), and decreasing age. EBL, autoLog use, high surgeon case volume, vascular procedures, and emergent versus elective procedures associated with higher odds of at least 1 rRBC. CONCLUSION: Discrepancy between rRBC and EBL and high percentages of cases with no rRBC suggests that PBR technique and case selection need optimization. Identification of procedure types and variables associated with PBR efficacy (≥1 rRBC) should improve utilization of PBR. Association of autoLog use with higher rRBC warrants further investigation.

Cost-effectiveness of blood donor screening for Babesia microti in endemic regions of the United States.

BACKGROUND: Babesia microti is the leading reported cause of red blood cell (RBC) transfusion-transmitted infection in the United States. Donor screening assays are in development. STUDY DESIGN AND METHODS: A decision analytic model estimated the cost-effectiveness of screening strategies for preventing transfusion-transmitted babesiosis (TTB) in a hypothetical cohort of transfusion recipients in Babesia-endemic areas of the United States. Strategies included: 1) no screening; 2) Uniform Donor Health History Questionnaire (UDHQ), "status quo"; 3) recipient risk targeting using donor antibody and polymerase chain reaction (PCR) screening; 4) universal endemic donor antibody screening; and 5) universal endemic donor antibody and PCR screening. Outcome measures were TTB cases averted, costs, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios (ICERs; $/QALY). We assumed a societal willingness to pay of $1 million/QALY based on screening for other transfusion-transmitted infections. RESULTS: Compared to no screening, the UDHQ avoids 0.02 TTB cases per 100,000 RBC transfusions at an ICER of $160,000/QALY whereas recipient risk-targeted strategy using antibody/PCR avoids 1.62 TTB cases per 100,000 RBC transfusions at an ICER of $713,000/QALY compared to the UDHQ. Universal endemic antibody screening avoids 3.39 cases at an ICER of $760,000/QALY compared to the recipient risk-targeted strategy. Universal endemic antibody/PCR screening avoids 3.60 cases and has an ICER of $8.8 million/QALY compared to universal endemic antibody screening. Results are sensitive to blood donor Babesia prevalence, TTB transmission probability, screening test costs, risk and severity of TTB complications, and impact of babesiosis diagnosis on donor quality of life. CONCLUSION: Antibody screening for Babesia in endemic regions is appropriate from an economic perspective based on the societal willingness to pay for preventing infectious threats to blood safety.

The integration of high-throughput testing of blood donors for cardiovascular disease risk assessment and prevention.

BACKGROUND AND OBJECTIVES: Some blood centers provide health screening as a public health measure and to encourage donation. The goal of the current study was to provide cardiovascular disease (CVD) screening to donors using high-throughput testing and web-based communications. MATERIALS AND METHODS: CVD risk screening was offered to donors at selected mobile drives in a large metropolitan area. Risk factors were determined by donor questionnaire, laboratory testing (total cholesterol, HDL levels and hemoglobin A1c), and blood pressure measurement. Results were reported to participants via mail and website. A 60-day follow up web-based survey was sent to participants via email to assess the impact of the program on donor's behavior. RESULTS: 9435 donors, 17-75 years old participated with the following risk factors: 61.3% BMIs>25, 28.8% high total cholesterol, and 31.4% lower than recommended HDL levels. 25.3% of donors that responded to the follow up survey went to see their health care provider based on screening results and 9% of these received new or modified treatment. CONCLUSION: In our sample, blood donors are healthier than the general population, but many still have CVD risk factors, particularly obesity. CVD screening can be successfully used to make donors aware of this important health information and some donors act on this information.

Blood donations motivators and barriers: a descriptive study of African American and white voters.

African American adults are half as likely to donate blood than whites. In order to understand this difference, African American and white participants completed a survey regarding demographics, medical and donation history, and motivators and barriers. The most agreed upon motivators to blood donation were more convenient place and times, being asked and taking less than hour. Motivator responses which differed by race included donating for infectious disease test and reward, and assurance donating is safe. The most agreed upon barriers were not having a convenient place, not knowing where (response differed by race) and fear of needles, pain and feeling faint.

Cardiovascular disease risk assessment and prevention in blood donors.

BACKGROUND: Blood centers have implemented public health initiatives, including cardiovascular disease (CVD) screening, to improve donor and community health and serve as an incentive to donate. STUDY DESIGN AND METHODS: CVD risk screening and counseling were performed at mobile blood drives in diverse neighborhoods. Risk factors were determined by point-of-care testing (total cholesterol, high-density lipoprotein, and hemoglobin A1c levels), interviews, and physical examinations (body mass index, waist circumference, and blood pressure). Results were confidentially relayed to participant by health counselors. A 60-day follow-up survey was sent to some participants. RESULTS: Over 11 months, 2406 participants (44% male; mean age 28 ± 16; 67% minority racial/ethnic group) were screened at 290 mobile drives. A total of 92% of participants had medical insurance. A total of 14% had none, 26% one, 33% two, and 27% three or more risk factors. A total of 72% of teenage participants had at least one risk factor. A total of 18% of participants who were taking medications for risks were poorly controlled. A total of 15% had newly identified risks. A total of 711 participants completed follow-up survey: 21% sought medical care, 51% were motivated to change their lifestyle, 81% were pleased with screening, 48% were more likely to donate, and 62% recommended donation to friends and family because of the screening. CONCLUSION: CVD risk screening and counseling can occur during a mobile blood drive. A majority of participants screened had risk factors. Follow-up surveys showed that the program was well received. Further studies are planned to evaluate long-term effects of the program on donor health and donor return rates.

Contribution of attitudinal factors to blood donation in African American church attendees.

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<0.001) than nondonors. CONCLUSION: African American distrust of the health care system is associated with decreased likelihood of previous blood donation. This may be secondary to donor centers being viewed as a component of the health care system. Building trust between donor centers and African American community by ensuring the safety of donation may increase African American blood donation rates.