Objectives

The objectives of the Recipient Epidemiology and Donor Evaluation Study-III (REDS-III) program are to ensure safe and effective blood banking and transfusion medicine practices through a comprehensive, multifaceted strategy involving basic, translational, and clinical research to improve the benefits of transfusion while reducing its risks. To meet these goals, a detailed research vein to vein database infrastructure that links data from blood donors and their donations, the components made from these donations, and the recipients of these components, was developed.

Background

REDS-III is a transfusion safety research initiative as a successor to two previous NHLBI multicenter epidemiology programs (REDS and REDS-II) initiated in response to the HIV epidemic. The emphasis of REDS-III has shifted to recipient-based research, particularly transfusion epidemiology and outcomes, and to evaluating whether donor factors affect recipient outcomes. Studies in the areas of blood donor safety and availability and the retention of a rapid response capability to evaluate the threat of new emerging infectious agents in the blood supply remain important features of the current program.

Participants

The REDS-III domestic program included four blood centers and 12 hospitals across the United States. The REDS-III team collected data from over 2,500,000 donations and attempted donations, over 6.5 million components that were donated or made from donated whole blood, 120,290 transfusion recipients over 234,277 encounters, and 1,285,359 encounters with non-transfused patients (as a comparison group). Donor and component data were collected from July 2012 through December 2016. Some additional data from donations and attempted donations prior to July 2012 were also included. Data collection from recipients began in January 2013 and continued through December 2016.

Design

The REDS-III domestic program has established for the first time a detailed research database infrastructure that links data from blood donors and their donations, the components made from these donations, and the recipients of these components; i.e., a particular donation can be traced through component production and, if transfused at a participating hospital, to a data extract from the electronic medical record of the transfusion recipient. This permits the conduct of numerous analyses that characterize blood component utilization patterns in diverse settings, inform the design of future clinical trials, and potentially determine blood donor/donation effects on recipients’ clinical outcomes.

The database is comprised of three sets of core files. The donor/donation files contain information on attempted and successful donations of whole blood and blood products, as well as deferrals and the reasons for them. The component files contain information on processing of donated blood and blood products, such as separation of whole blood into red blood cells, platelets and plasma, as well as manufacturing modifications, such as irradiation or leukocyte reduction. The transfusion recipient files contain information on both inpatient and outpatient transfusion recipients, such as type of product transfused, number of units transfused each day, and adverse outcomes for transfused patients. Some recipients contributed data from a single encounter while others contributed data from two or more encounters. Multiple encounters with the same recipient may have been entirely outpatient visits, entirely hospitalizations or a mix of the two. Data were also collected from patients who were not transfused during their hospitalizations.

Kleinman S, Busch MP, Murphy EL, et al. 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. Transfusion. 2014;54(3 Pt 2):942–955. doi:10.1111/trf.12468

Karafin MS, Bruhn R, Westlake M, et al. Demographic and epidemiologic characterization of transfusion recipients from four US regions: evidence from the REDS-III recipient database. Transfusion. 2017;57:2903-2913. doi:10.1111/trf.14370

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