Hepatitis Clinical Trial
Official title:
A Controlled Prospective Study of Transfusion-Associated Hepatitis
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.
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.
;
N/A
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