Effectiveness of AIDS Antibody Screening
Este estudio tiene como objetivo observar y evaluar el riesgo de infección por VIH a través de la transfusión de sangre que ha dado negativo en la prueba de VIH.
Colección de datos
Infecciones Transmitidas por la Sangre+12
+ Enfermedades Urogenitales
+ Enfermedades Genitales
Historia Natural
Observación de la progresión de una enfermedad en personas no tratadas para comprender su curso y resultados típicos.Resumen
Fecha de inicio: 1 de septiembre de 1986
Fecha en la que se inscribió al primer participante.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.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Historia Natural
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Hombre
Sexo biológico de los participantes elegibles para inscribirse.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
No eligibility criteria