ANALYSIS OF TRANSFUSION-RELATED ADVERSE EVENTS BASED ON A PILOT STUDY -TOWARD A COMPREHENSIVE HEMOVIGILANCE SYSTEM FOR JAPAN-

Abstract

Although blood transfusion is an essential and effective therapy, transfusion-related adverse events remain possible due to the allogeneic origin of blood products. In order to grasp and deal with these adverse events, a comprehensive reporting system, namely a hemovigilance system, needs to be established in Japan. We have been running a pilot study since 2007, in which all grades of transfusion-related adverse events are collected bimonthly using an online system. Seven university hospitals initially participated in this study, and were joined by five small hospitals (with fewer than 300 beds) in 2009. This paper reports the result of analysis of the data collected from 2007 to 2009.
Over the three years, the overall incidence of adverse events per bag was 1.50%. Platelet concentrate (PC) (4.34%) gave rise to statistically more adverse events (6-fold) than both red cell concentrate and fresh frozen plasma. This difference was possibly caused by allo-immunization of PC recipients, because these patients, who commonly have with hematological diseases, tend to receive regular blood transfusions, and thus to be frequently allo-immunized. In addition, we found that the incidence of adverse events varied between hospitals by number of beds and patient characteristics.
In conclusion, this online reporting system may be useful for the collection and analysis of actual adverse events in recipients, and may contribute to the development of a more comprehensive hemovigilance system in Japan.