Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00005303
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
2000-05-25
Brief Title:
Effectiveness of AIDS Antibody Screening
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:
2001-12
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 determine the effectiveness of efforts to eliminate the human immunodeficiency virus HIV from whole blood and blood components in the blood supply
Detailed Description:
BACKGROUND
In 1986 despite programs to have persons with known risk factors for exposure to the AIDS virus exclude themselves from the blood donating population and the universal testing of all donated whole blood and blood components for the antibody to HIV the public was fearful of acquiring AIDS via transfusion and media stories increased that fear A major concern among members of the blood banking community was the extent to which donors infected with HIV were not identified by enzyme-linked immunoassay EIA systems Most experts believed that self-deferral and the assays for the HIV antibody were eliminating the vast majority of positive units of donated blood and blood components If all units containing HIV were being eliminated by the combined effects of self-deferral and antibody screening and treatment of factor VIII concentrates no recipients of only screened whole blood or blood components or factor VIII would become HIV virus and antibody positive as the result of transfusion Alternately if some HIV positive units of whole blood or blood components or factor VIII concentrates were not being eliminated by self-deferral and antibody screening and treatment of factor VIII concentrates and these units were transfused then some transfusion recipients would become HIV antibody positive and viremic
The initiative was part of a special Fiscal Year 1986 National Heart Lung and Blood Institute AIDS Plan The concept was reviewed and approved by the National Heart Lung and Blood Advisory Council in February 1986 The Request for Proposals was released in May 1986 Two contracts were awarded in September 1986
DESIGN NARRATIVE
University of California at San Francisco A risk assessment was made of HIV infection through prospective testing for seroconversion in women recipients of anti-HIV negative blood transfusions at the University of California San Francisco hospitals Blood specimens were collected from each of the recipients pre-transfusion and at two four and six months post-transfusion Patients were selected based on female sex and exclusion of high risk behavior or blood transfusion during the preceding six months
Johns Hopkins University The rate of seroconversion was determined in a cohort of cardiac surgery patients receiving multiple transfusions of blood products screened for HIV antibody The study was conducted at the Johns Hopkins Hospital the Texas Heart Institute and the Methodist Hospital in Houston A serum sample for each patient was collected before surgery and a second sample was collected at least six months after surgery
In 1986 despite programs to have persons with known risk factors for exposure to the AIDS virus exclude themselves from the blood donating population and the universal testing of all donated whole blood and blood components for the antibody to HIV the public was fearful of acquiring AIDS via transfusion and media stories increased that fear A major concern among members of the blood banking community was the extent to which donors infected with HIV were not identified by enzyme-linked immunoassay EIA systems Most experts believed that self-deferral and the assays for the HIV antibody were eliminating the vast majority of positive units of donated blood and blood components If all units containing HIV were being eliminated by the combined effects of self-deferral and antibody screening and treatment of factor VIII concentrates no recipients of only screened whole blood or blood components or factor VIII would become HIV virus and antibody positive as the result of transfusion Alternately if some HIV positive units of whole blood or blood components or factor VIII concentrates were not being eliminated by self-deferral and antibody screening and treatment of factor VIII concentrates and these units were transfused then some transfusion recipients would become HIV antibody positive and viremic
The initiative was part of a special Fiscal Year 1986 National Heart Lung and Blood Institute AIDS Plan The concept was reviewed and approved by the National Heart Lung and Blood Advisory Council in February 1986 The Request for Proposals was released in May 1986 Two contracts were awarded in September 1986
DESIGN NARRATIVE
University of California at San Francisco A risk assessment was made of HIV infection through prospective testing for seroconversion in women recipients of anti-HIV negative blood transfusions at the University of California San Francisco hospitals Blood specimens were collected from each of the recipients pre-transfusion and at two four and six months post-transfusion Patients were selected based on female sex and exclusion of high risk behavior or blood transfusion during the preceding six months
Johns Hopkins University The rate of seroconversion was determined in a cohort of cardiac surgery patients receiving multiple transfusions of blood products screened for HIV antibody The study was conducted at the Johns Hopkins Hospital the Texas Heart Institute and the Methodist Hospital in Houston A serum sample for each patient was collected before surgery and a second sample was collected at least six months after surgery
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?: