Trial record 2 of 4 for:    "Human T-cell leukemia virus type 2"

Retrovirus Epidemiology Donor Study-II (REDS-II)

This study has been completed.
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00097006
First received: November 17, 2004
Last updated: September 2, 2009
Last verified: September 2009
  Purpose

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.


Condition
Acquired Immunodeficiency Syndrome
Blood Donors
Blood Transfusion
HIV Infections
HIV-1
HIV-2
HTLV-I
HTLV-II
Retroviridae Infections
Hepatitis, Viral, Human
Hepatitis B
Hepacivirus
West Nile Virus

Study Type: Observational

Resource links provided by NLM:


Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date: September 2004
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

No eligibility criteria

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00097006

Sponsors and Collaborators
Investigators
Investigator: Michael Busch Blood Systems Research Institute
Investigator: Jerome Gottschall Blood Center of Southeastern Wisconsin, Inc.
Investigator: Christopher Hillyer Emory University
Investigator: Ram Kakaiya Institute for Transfusion Medicine
Investigator: Edward Murphy University of California, San Francisco
Investigator: Jorge Rios American Red Cross Blood Services, New England Region
Investigator: Ronald Sacher University of Cincinnati
Investigator: George Schreiber Westat, Inc.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00097006     History of Changes
Other Study ID Numbers: 1243
Study First Received: November 17, 2004
Last Updated: September 2, 2009
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Infection
Communicable Diseases
Hepatitis
Hepatitis A
HIV Infections
Acquired Immunodeficiency Syndrome
Hepatitis B
Immunologic Deficiency Syndromes
Retroviridae Infections
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Lentivirus Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immune System Diseases
Slow Virus Diseases
Hepadnaviridae Infections
DNA Virus Infections

ClinicalTrials.gov processed this record on September 18, 2014