Retrovirus Epidemiology Donor Study-II (REDS-II)

To conduct epidemiological, laboratory, and survey research on volunteer blood donors within the United States to ensure the safety and availability of the United States' blood supply.

Study Overview

• Status: Completed
• Conditions: HIV Infections; Acquired Immunodeficiency Syndrome; Retroviridae Infections; Hepatitis B; Hepatitis, Viral, Human; Blood Transfusion; HIV-1; Blood Donors; Hepacivirus; HIV-2; HTLV-I; HTLV-II; West Nile Virus

Detailed Description

BACKGROUND:

REDS-I was established to address important blood safety issues involving human retroviruses. On July 17, 1989 the NHLBI awarded contracts to five major blood centers and a coordinating center to develop a major multicenter epidemiologic study of the human retroviruses HIV-1, HIV-2, HTLV-I, and HTLV-II in volunteer U.S. blood donors. The original mission of REDS-I was to initiate and facilitate investigations of human retroviruses in volunteer blood donors from areas of the country at varying risk for HIV. During the course of the project, NHLBI expanded the original REDS-I mission to investigate critical questions posed by the blood banking and transfusion medicine communities that were essential to ensuring an adequate blood supply without compromising blood safety. The overall REDS-I program includes epidemiologic, laboratory, and clinical investigations, and provides a comprehensive framework for monitoring U.S. blood donations, and more recently transfusion recipients, for infectious disease markers. The operational and database structure of REDS-I, specifically designed to study U.S. blood safety and availability, has also provided a framework for rapid analytical response to other research questions of significant importance to the safety of the blood supply. Since its inception, investigators have made major contributions in assessing: the risk of contracting transfusion-transmitted infectious agents; HIV and HCV test screening; donor characteristics and behaviors; and ways of reducing HIV risk from transfusion. REDS-I investigators work closely with the Food and Drug Administration (FDA), Centers for Disease Control and Prevention (CDC) and Office of the Secretary, Department of Health and Human Services (DHHS) to provide data and analyses for important policy decisions. Liaisons with test manufacturers have enabled the rapid study of test procedures of critical importance to blood safety and availability.

DESIGN NARRATIVE:

The objectives of the Retrovirus Epidemiology Donor Study-II (REDS-II) are to conduct epidemiological, laboratory, and survey research on volunteer blood donors within the United States to ensure the safety and availability of the United States' blood supply. This includes monitoring known blood-borne infectious agents, rapidly evaluating the impact of emerging pathogens, assessing the safety implications of changes in laboratory and/or blood donor screening protocols and examining blood supply and availability issues. Addressing issues concerned with the safety and availability of the United States' blood supply will be the cornerstone of the National Heart, Lung, and Blood Institute's Retrovirus Epidemiology Donor Study. These issues include: a) the risks of transfusion-transmissible infections and their trends through time--these include infectious agents currently undergoing laboratory screening as well as new and emerging agents such as West Nile Virus (WNV) which is about to be screened for in the U.S. under experimental protocols; b) ways to reduce the risks of transfusion-transmissible infections; c) HIV, HTLV, HCV, and HBV test screening methodologies; d) donor characteristics, behaviors, and donation return patterns of U.S. blood donors; and e) the effectiveness and safety of various strategies implemented to increase the U.S. blood supply.

• Study Type: Observational

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 100 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

No eligibility criteria

Study Plan

How is the study designed?

Collaborators and Investigators

• Sponsor: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Michael Busch, Blood Systems Research Institute; Jerome Gottschall, Blood Center of Southeastern Wisconsin, Inc.; Christopher Hillyer, Emory University; Ram Kakaiya, Institute for Transfusion Medicine; Edward Murphy, University of California, San Francisco; Jorge Rios, American Red Cross Blood Services, New England Region; Ronald Sacher, University of Cincinnati; George Schreiber, Westat, Inc.

Publications and helpful links

General Publications

• Mast AE, Schlumpf KS, Wright DJ, Johnson B, Glynn SA, Busch MP, Olbina G, Westerman M, Nemeth E, Ganz T; NHLBI Retrovirus Epidemiology Donor Study-II (REDS-II). Hepcidin level predicts hemoglobin concentration in individuals undergoing repeated phlebotomy. Haematologica. 2013 Aug;98(8):1324-30. doi: 10.3324/haematol.2012.070979. Epub 2013 Feb 26.

Study record dates

Study Major Dates

• Study Start: September 1, 2004
• Primary Completion (Actual): September 1, 2009
• Study Completion (Actual): September 1, 2009

Study Registration Dates

• First Submitted: November 17, 2004
• First Submitted That Met QC Criteria: November 17, 2004
• First Posted (Estimate): November 18, 2004

Study Record Updates

• Last Update Posted (Estimate): April 15, 2016
• Last Update Submitted That Met QC Criteria: April 14, 2016
• Last Verified: September 1, 2009

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; RNA Virus Infections; Virus Diseases; Blood-Borne Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Immune System Diseases; Disease Attributes; Liver Diseases; Hepadnaviridae Infections; DNA Virus Infections; Enterovirus Infections; Picornaviridae Infections; Slow Virus Diseases; HIV Infections; Infections; Communicable Diseases; Hepatitis B; Hepatitis; Hepatitis A; Acquired Immunodeficiency Syndrome; Immunologic Deficiency Syndromes; Hepatitis, Viral, Human; Retroviridae Infections
• Other Study ID Numbers: 1243

Plan for Individual participant data (IPD)

Study Data/Documents

1. Individual Participant Data Set
   Information identifier: REDS II-CORE
   Information comments: NHLBI provides controlled access to IPD through BioLINCC. Access requires registration, evidence of local IRB approval or certification of exemption from IRB review, and completion of a data use agreement.
2. Manual of Procedures
   Information identifier: REDS II-CORE
3. Individual Participant Data Set
   Information identifier: REDS II-LAPS
   Information comments: NHLBI provides controlled access to IPD through BioLINCC. Access requires registration, evidence of local IRB approval or certification of exemption from IRB review, and completion of a data use agreement.
4. Study Protocol
   Information identifier: REDS II-LAPS
5. Study Forms
   Information identifier: REDS II-LAPS
6. Manual of Procedures
   Information identifier: REDS II-LAPS
7. Individual Participant Data Set
   Information identifier: REDS II-MS
   Information comments: NHLBI provides controlled access to IPD through BioLINCC. Access requires registration, evidence of local IRB approval or certification of exemption from IRB review, and completion of a data use agreement.
8. Study Protocol
   Information identifier: REDS II-MS
9. Manual of Procedures
   Information identifier: REDS II-MS
10. Individual Participant Data Set
    Information identifier: REDS II-RISE
    Information comments: NHLBI provides controlled access to IPD through BioLINCC. Access requires registration, evidence of local IRB approval or certification of exemption from IRB review, and completion of a data use agreement.
11. Study Protocol
    Information identifier: REDS II-RISE
12. Study Forms
    Information identifier: REDS II-RISE
13. Manual of Procedures
    Information identifier: REDS II-RISE