Elsevier

Transfusion Medicine Reviews

Volume 26, Issue 4, October 2012, Pages 281-304.e2
Transfusion Medicine Reviews

The National Heart, Lung, and Blood Institute Retrovirus Epidemiology Donor Studies (Retrovirus Epidemiology Donor Study and Retrovirus Epidemiology Donor Study-II): Twenty Years of Research to Advance Blood Product Safety and Availability

https://doi.org/10.1016/j.tmrv.2012.04.004Get rights and content

The Retrovirus Epidemiology Donor Study (REDS), conducted from 1989 to 2001, and the REDS-II, conducted from 2004 to 2012, were National Heart, Lung, and Blood Institute–funded, multicenter programs focused on improving blood safety and availability in the United States. The REDS-II also included international study sites in Brazil and China. The 3 major research domains of REDS/REDS-II have been infectious disease risk evaluation, blood donation availability, and blood donor characterization. Both programs have made significant contributions to transfusion medicine research methodology by the use of mathematical modeling, large-scale donor surveys, innovative methods of repository sample storage, and establishing an infrastructure that responded to potential emerging blood safety threats such as xenotropic murine leukemia virus–related virus. Blood safety studies have included protocols evaluating epidemiologic and/or laboratory aspects of human immunodeficiency virus, human T-lymphotropic virus 1/2, hepatitis C virus, hepatitis B virus, West Nile virus, cytomegalovirus, human herpesvirus 8, parvovirus B19, malaria, Creutzfeldt-Jakob disease, influenza, and Trypanosoma cruzi infections. Other analyses have characterized blood donor demographics, motivations to donate, factors influencing donor return, behavioral risk factors, donors' perception of the blood donation screening process, and aspects of donor deferral. In REDS-II, 2 large-scale blood donor protocols examined iron deficiency in donors and the prevalence of leukocyte antibodies. This review describes the major study results from over 150 peer-reviewed articles published by these 2 REDS programs. In 2011, a new 7-year program, the Recipient Epidemiology and Donor Evaluation Study-III, was launched. The Recipient Epidemiology and Donor Evaluation Study-III expands beyond donor-based research to include studies of blood transfusion recipients in the hospital setting and adds a third country, South Africa, to the international program.

Section snippets

Participating Institutions

The REDS and REDS-II each was structured around a central coordinating center, a central laboratory, and multiple participating blood centers as described in Online Appendix A. In each program, donations collected by the participating blood centers comprised approximately 8% of total US collections. An international component, conducted in China and Brazil, respectively, was added to the REDS-II program in 2006 and was organized with a similar infrastructure (Online Appendix B).

The Domestic Research Program—Major Findings

The REDS and REDS-II have made substantial contributions in 3 major research areas in transfusion medicine/blood banking in the United States, namely, infectious disease risk evaluation, blood donation availability, and blood donor characterization. The largest body of research conducted by the REDS and REDS-II was related to transfusion-transmitted infectious disease risks and included (a) assessing the prevalence and incidence, residual risks, and test yield rates of known

The International Research Program—Major Studies and Findings

Research efforts in the REDS-II international programs in Brazil and China have focused on the primary goal of identifying the scope of HIV/acquired immunodeficiency syndrome transfusion-transmission in these countries as well as other known transfusion-transmitted agents (eg, HBV and HCV) and novel or emerging agents of potential public health concern (eg, dengue virus and Trypanosoma cruzi). These international programs provide the opportunity to acquire data on new or emerging infectious

The REDS-III

The REDS and REDS-II were focused on donor research issues but, in the later years, conducted a few studies involving transfusion recipients (B19V transfusion-transmission study using the RADAR repository; LAPS-II). To focus additional research on transfusion recipients while maintaining the capability to respond to new threats and to continue donor-related research, a successor program, the REDS-III, was established in 2011. Similar to REDS-II, REDS-III includes a domestic and an international

Acknowledgments

The authors thank the many additional investigators, scientists, study coordinators, laboratory technologists, statisticians, data analysts, and data managers whose contributions were vital to the success of these programs. Principal investigators and coprincipal investigators are listed in Online Appendix C.

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    Conflict of interest statement: Each of the authors declares that he/she has no conflicts of interest regarding any of the work presented in this publication.

    Contract support: The Retrovirus Epidemiology Donor Study was supported by the National Heart, Lung, and Blood Institute contracts N01-HB-97077 (superseded by N01-HB-47114), -97078, -97079, -97080, -97081, and -97082. The Retrovirus Epidemiology Donor Study-II was supported by the National Heart, Lung, and Blood Institute contracts N01-HB-47168, -47172, -47175, and -57181.

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