Proceedings of the 2022 NHLBI and OASH state of the science in transfusion medicine symposium.

Background: State of the Science (SoS) meetings are used to define and highlight important unanswered scientific questions. The National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health, and the Office of the Assistant Secretary for Health (OASH), Department of Health and Human Services held a virtual SoS in transfusion medicine (TM) symposium.

Study Design And Methods: In advance of the symposium, six multidisciplinary working groups (WG) convened to define research priorities in the areas of: blood donors and the supply, optimizing transfusion outcomes for recipients, emerging infections, mechanistic aspects of components and transfusion, new computational methods in transfusion science, and impact of health disparities on donors and recipients.

Recently acquired infection among HIV-seropositive donors in the US from 2010-2018.

Background: Monitoring of transfusion-transmissible infections in the blood supply is essential for blood safety, as the donor population is not static, and changes in policy, donor behavior, or other factors could increase the risk of recipient infection. We assessed patterns of recently acquired HIV infection in US blood donors, including before and after the implementation of the 12-month deferral for men who have sex with men (MSM).

Study Design And Methods: A large convenience sample of donations from donors testing HIV-1 nucleic acid testing (NAT) and serology-reactive were further tested with the Sedia HIV-1 Limiting Antigen enzyme immunoassay.

HIV incidence in US first-time blood donors and transfusion risk with a 12-month deferral for men who have sex with men.

In 2015, the US Food and Drug Administration published revised guidance that recommended a change in blood donor deferral of men who have sex with men (MSM) from an indefinite to a 12-month deferral since the donor last had sex with a man. We assessed whether HIV incidence in first-time blood donors or associated transfusion risk increased. Donations in 4 major blood collection organizations were monitored for 15 months before and 2 years after implementation of the 12-month MSM deferral policy.

HIV antiretroviral therapy and prevention use in US blood donors: a new blood safety concern.

Antiretroviral therapy (ART) to treat and pre-exposure prophylaxis (PrEP) to prevent HIV infection are effective tools to help end the HIV epidemic. However, their use could affect HIV transfusion-transmission risk. Three different ART/PrEP prevalence analyses in blood donors were conducted.

Methodological considerations for linked blood donor-component-recipient analyses in transfusion medicine research.

In recent years, there has been a concerted effort to improve our understanding of the quality and effectiveness of transfused blood components. The expanding use of large datasets built from electronic health records allows the investigation of potential benefits or adverse outcomes associated with transfusion therapy. Together with data collected on blood donors and components, these datasets permit an evaluation of associations between donor or blood component factors and transfusion recipient outcomes.

Association of donor age, body mass index, hemoglobin, and smoking status with in-hospital mortality and length of stay among red blood cell-transfused recipients.

Background: Recent publications have reported conflicting findings regarding associations of blood donor demographics and mortality of transfused patients. We hypothesized that the analysis of additional donor characteristics and consideration of alternative outcomes might provide insight into these disparate results.

Study Design And Methods: We analyzed data from a retrospective cohort of transfused patients from the Recipient Epidemiology and Donor Evaluation Study-III (REDS-III).

Iron status and risk factors for iron depletion in a racially/ethnically diverse blood donor population.

Background: The optimal approach for reducing iron depletion (ID) in blood donors may vary depending on biologic or behavioral differences across donors.

Study Design And Methods: More than 12,600 successful whole blood donors were enrolled from four US blood centers for ferritin testing. The study population was enriched for racial/ethnic minorities (1605 African American, 1616 Asian, 1023 Hispanic).

Association of Blood Donor Sex and Prior Pregnancy With Mortality Among Red Blood Cell Transfusion Recipients.

Importance: Evidence regarding associations of blood donor sex with mortality among red blood cell transfusion recipients is conflicting.

Objective: To study associations of donor sex and prior pregnancy with mortality of transfusion recipients.

Design, Setting, And Participants: Data from 3 retrospective cohorts of transfusion recipients (the Kaiser Permanente Northern California [KPNC] and Recipient Epidemiology and Donor Evaluation Study-III [REDS-III] databases of data from January 2013 to December 2016 and the Scandinavian Donations and Transfusions [SCANDAT] database with data from January 2003 to December 2012) were analyzed.

Elevated risk for iron depletion in high-school age blood donors.

Background: High school students 16 to 18 years-old contribute 10% of the US blood supply. Mitigating iron depletion in these donors is important because they continue to undergo physical and neurocognitive development.

Study Design And Methods: Study objectives were to determine the prevalence of iron depletion in 16- to 18-year-old donors and whether their risk for iron depletion was greater than adult donors.

Addressing gaps in international blood availability and transfusion safety in low- and middle-income countries: a NHLBI workshop.

In April 2017, a workshop sponsored by the National Heart, Lung, and Blood Institute, Division of Blood Diseases and Resources, and the Center for Translation Research and Implementation Science was held to discuss blood availability and transfusion safety in low- and middle-income countries (LMICs). The purpose of the workshop was to identify research opportunities for implementation science (IS) to improve the availability of safe blood and blood components and transfusion practices in LMICs. IS describes the late stages of the translational research spectrum and studies optimal and sustainable strategies to deliver proven-effective interventions.

Proceedings of the Food and Drug Administration's public workshop on new red blood cell product regulatory science 2016.

The US Food and Drug Administration (FDA) held a workshop on red blood cell (RBC) product regulatory science on October 6 and 7, 2016, at the Natcher Conference Center on the National Institutes of Health (NIH) Campus in Bethesda, Maryland. The workshop was supported by the National Heart, Lung, and Blood Institute, NIH; the Department of Defense; the Office of the Assistant Secretary for Health, Department of Health and Human Services; and the Center for Biologics Evaluation and Research, FDA. The workshop reviewed the status and scientific basis of the current regulatory framework and the available scientific tools to expand it to evaluate innovative and future RBC transfusion products.

A comparison of methods for estimating the incidence of human immunodeficiency virus infection in repeat blood donors.

Background: The incidence of human immunodeficiency virus (HIV) in repeat blood donors has been estimated using seven methods. Although incidence is always calculated as cases per person-time, approaches to selecting cases and calculating person-time vary. Incidence estimates have not been compared among methods.

Recent viral infection in US blood donors and health-related quality of life (HRQOL).

Purpose: Blood donors are considered to be one of the healthiest populations, but relatively little is known about their perceived quality of life. The objective was to examine HRQOL in donors infected with HIV, HBV, HCV or HTLV and a comparison group.

Methods: Donors with confirmed viral infection (cases) and donors who tested false-positive (controls) participated in a multicenter study of US blood donors (2010-2013), funded by the National Heart, Lung and Blood Institute (NHLBI).

Motivations for donating and attitudes toward screening policies in US blood donors with viral infection.

Background: Differences in motivating factors that contribute to the decision to donate blood between infected and uninfected donors may help to identify areas for improving donor education.

Study Design And Methods: As part of a risk factor study, confirmed-positive donors (cases) based on serology-only (human T-lymphotropic virus [HTLV]) or serology and nucleic acid testing (NAT) or NAT-only (human immunodeficiency virus [HIV], hepatitis B virus [HBV], hepatitis C virus [HCV]), and serology-unconfirmed, NAT-negative false-positive donors (controls) were asked about motivations and opinions toward blood donation. "Test seeking" was inferred if a donor answered "yes" to "I wanted to get my test results" and one of the following: "blood center testing is confidential," "free," "more accurate than other test centers," or "tests will identify problems with my blood.

Potential impact on blood availability and donor iron status of changes to donor hemoglobin cutoff and interdonation intervals.

Background: A minimum male hemoglobin (Hb) level of 13.0 g/dL becomes a Food and Drug Administration requirement effective May 2016. In addition, extending whole blood (WB) interdonation intervals (IDIs) beyond 8 weeks has been considered to reduce iron depletion in repeat blood donors.

Effect of iron supplementation on iron stores and total body iron after whole blood donation.

Background: Understanding the effect of blood donation and iron supplementation on iron balance will inform strategies to manage donor iron status.

Study Design And Methods: A total of 215 donors were randomized to receive ferrous gluconate daily (37.5 mg iron) or no iron for 24 weeks after blood donation.

Oral iron supplementation after blood donation: a randomized clinical trial.

Importance: Although blood donation is allowed every 8 weeks in the United States, recovery of hemoglobin to the currently accepted standard (12.5 g/dL) is frequently delayed, and some donors become anemic.

Objective: To determine the effect of oral iron supplementation on hemoglobin recovery time (days to recovery of 80% of hemoglobin removed) and recovery of iron stores in iron-depleted ("low ferritin," ≤26 ng/mL) and iron-replete ("higher ferritin," >26 ng/mL) blood donors.

The National Heart, Lung, and Blood Institute Recipient Epidemiology and Donor Evaluation Study (REDS-III): a research program striving to improve blood donor and transfusion recipient outcomes.

Background: The Recipient Epidemiology and Donor Evaluation Study-III (REDS-III) is a 7-year multicenter transfusion safety research initiative launched in 2011 by the National Heart, Lung, and Blood Institute.

Study Design And Methods: The domestic component involves four blood centers, 12 hospitals, a data coordinating center, and a central laboratory. The international component consists of distinct programs in Brazil, China, and South Africa, which involve US and in-country investigators.

Restless legs syndrome, pica, and iron status in blood donors.

Background: The association of blood donation-related iron deficiency with pica or restless legs syndrome (RLS) remains poorly elucidated. This study evaluated the prevalence of RLS and pica in blood donors completing the REDS-II Iron Status Evaluation (RISE) study.

Study Design And Methods: RISE enrolled 2425 blood donors in a prospective cohort study; 1334 donors provided blood samples to characterize iron status and answered a questionnaire inquiring into symptoms of RLS and pica at a final visit after 15 to 24 months of follow-up.