Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT00097006 |
| Other study ID # |
1243 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
November 17, 2004 |
| Last updated |
April 14, 2016 |
| Start date |
September 2004 |
| Est. completion date |
September 2009 |
Study information
| Verified date |
September 2009 |
| Source |
National Heart, Lung, and Blood Institute (NHLBI) |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
United States: Federal Government |
| Study type |
Observational
|
Clinical Trial Summary
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.
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.
