Ignite Creation Date:
2024-05-05 @ 11:37 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00097006
Status:
COMPLETED
Last Update Posted:
2016-04-15
First Post:
2004-11-17
Brief Title:
Retrovirus Epidemiology Donor Study-II REDS-II
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2009-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 US 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 US blood donations and more recently transfusion recipients for infectious disease markers The operational and database structure of REDS-I specifically designed to study US 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 andor 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 Institutes 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 US 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 US blood donors and e the effectiveness and safety of various strategies implemented to increase the US blood supply
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 US 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 US blood donations and more recently transfusion recipients for infectious disease markers The operational and database structure of REDS-I specifically designed to study US 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 andor 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 Institutes 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 US 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 US blood donors and e the effectiveness and safety of various strategies implemented to increase the US blood supply
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: