NCT00004848

A Controlled Prospective Study of Transfusion-Associated Hepatitis

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 2,000 (planned)
• Sponsor: National Institutes of Health Clinical Center (CC) · NIH
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

This protocol represents a continuation of a series of prospective studies to define the incidence and etiology of transfusion-associated hepatitis (TAH) and to examine the impact on TAH of various modifications in the selection of blood donors. The primary goal of the study will be to determine TAH incidence after the institution of a variety of interventive measures to exclude hepatitis and AIDS virus carriers: including surrogate assays (ALT, anti-HBc), a specific assay for the hepatitis C virus (HCV), a specific assay for the human immunodeficiency virus (HIV) and intensified donor questioning for high-risk behavior patterns. There is high probability that the exclusion of donors at high risk for AIDS transmission will also exclude donors at high risk for hepatitis transmission. Incidence data obtained in the study will be enhanced by the simultaneous follow-up of a control population undergoing identical surgical procedures, but receiving no blood or only autologous blood. This control population, made possible by the recent dramatic increase in the amount of autologous blood utilized, will allow for a clear distinction between transfusion-associated hepatitis and that due to nosocomial transmission or other background causes of hepatocellular inflammation in cardiac surgery patients.

Detailed description

This protocol represents a continuation of a series of prospective studies to define the incidence and etiology of transfusion-associated hepatitis (TAH) and to examine the impact on TAH of various modifications in the selection of blood donors. The primary goal of the study will be to determine TAH incidence after the institution of a variety of interventive measures to exclude hepatitis and AIDS virus carriers: including surrogate assays (ALT, anti-HBc), a specific assay for the hepatitis C virus (HCV), a specific assay for the human immunodeficiency virus (HIV) and intensified donor questioning for high-risk behavior patterns. There is high probability that the exclusion of donors at high risk for AIDS transmission will also exclude donors at high risk for hepatitis transmission. Incidence data obtained in the study will be enhanced by the simultaneous follow-up of a control population undergoing identical surgical procedures, but receiving no blood or only autologous blood. This control population, made possible by the recent dramatic increase in the amount of autologous blood utilized, will allow for a clear distinction between transfusion-associated hepatitis and that due to nosocomial transmission or other background causes of hepatocellular inflammation in cardiac surgery patients.

Conditions

• Hepatitis

Timeline

• Start date: 1981-07-01
• Completion: 2000-05-01
• First posted: 2002-12-10
• Last updated: 2008-03-04

Locations

1 site across 1 country: United States