Viral Activation Transfusion Study (VATS)
Palabras clave
Abstracto
Descripción
BACKGROUND:
The initiative was approved by the NHLBI AIDS Ad Hoc Working Group and given concept clearance by the September 1993 National Heart, Lung, and Blood Advisory Council. The initiative was released in January 1994.
DESIGN NARRATIVE:
Patient enrollment started in August 1995. Patients scheduled for transfusion were entered into the study at the time of their first transfusion and randomized to receive leukopoor red cells filtered within 24 hours of collection or unmanipulated blood components. Patients received blood as per their treatment arm as needed for one or two years. Patients were stratified to those with CD4 counts below 50 /MM3 (most patients) and those with CD4 counts above that level. Primary endpoints were overall survival and a change in HIV viremia after the 1st transfusion. The secondary endpoint was the occurrence of a new AIDS-defining complication. A substudy looked at donor lymphocytes in the immunosuppressed recipients to help determine why AIDS patients don't seem to get post-transfusion graft-vs-host disease. The patient recruitment time was extended for one year because of low accrual. With new drugs, especially protease inhibitors, the proportion of patients needing transfusion has decreased. The patients are less severely ill and their disease produces less anemia. Furthermore, the new drugs don't have anemia as a side effect. The trial ended in January, 2000.
The study completion date listed in this record was obtained from the "Completed Date" entered in the Query View Report System (QVR).
fechas
Verificado por última vez: | 11/30/2005 |
Primero enviado: | 10/26/1999 |
Inscripción estimada enviada: | 10/26/1999 |
Publicado por primera vez: | 10/27/1999 |
Última actualización enviada: | 07/10/2016 |
Última actualización publicada: | 07/11/2016 |
Fecha de inicio real del estudio: | 10/31/1994 |
Fecha estimada de finalización del estudio: | 02/28/2001 |
Condición o enfermedad
Intervención / tratamiento
Procedure: blood transfusion
Fase
Criterio de elegibilidad
Edades elegibles para estudiar | 18 Years A 18 Years |
Sexos elegibles para estudiar | All |
Acepta voluntarios saludables | si |
Criterios | HIV-infected patients with CD4 counts below 250 who clinically needed red blood cell transfusions. |