RANDOMIZED, DOUBLE-BLIND CONTROLLED TRIAL OF EFFICACY OF IMMUNE SERUM GLOBULIN FOR PREVENTION OF POST-TRANSFUSION HEPATITIS A VETERANS ADMINISTRATION COOPERATIVE STUDY

Abstract

A double blind, randomized, controlled trial was conducted in 11 Veterans Administration hospitals [in the USA] during a 49 mo. period to compare the relative efficacies of immune serum globulin (ISG) and an albumin placebo for the prevention of post-transfusion hepatitis (PTH). A total of 2204 patients, of whom 1094 received ISG, participated in the study. ISG significantly reduced the incidence of icteric type non-B hepatitis only (inferred also to be type non-A hepatitis). Adverse reactions were rare, and the ISG did not significantly alter the incubation period or duration of the disease. A similar reduction in type non-A, non-B hepatitis probably would have occurred if commercial blood were excluded from use. Analysis of the 241 patients who developed hepatitis indicates that type B hepatitis constituted less than 20% of the cases each year of the study. The efficacy of the ISG, manufactured in 1944, against apparent type non-A, non-B hepatitis suggests that this overlooked disease has existed from at least that time. Host- and transfusion-related factors that might have modified the development of PTH were examined. The use of commercial blood was the most important risk factor. The PTH incidence can be most effectively reduced by eliminating commercial donor blood, and continuing to screen volunteer donors for hepatitis B surface antigen (HBsAg) by sensitive procedures. Of prime importance is the need to define the agent(s) responsible for type non-A, non-B hepatitis.