TRANSFUSE is a multi-centre, randomised, controlled trial in critically ill adult patients in Ireland and Australia to determine whether, compared to standard care, transfusion of the freshest available allogenic red blood cells (RBC), decreases patient mortality. Red blood cell (RBC) transfusion is a very common and potentially life-saving treatment in intensive care units (ICUs). Attention has focused on the possible adverse impact of transfusing RBC which have been stored for a prolonged time. The term “storage lesion” refers to the fact that during storage, in a way that increases over time, red cells develop important biochemical and structural derangements. These age-related changes in transfused RBC may have important clinical consequences. Observational studies support an association between the transfusion of older RBC and adverse outcomes in critically ill patients. The proposed study question is now of major importance to ICU clinicians, transfusion specialists and the Blood Service. We will enrol ICU patients due to receive a blood transfusion. The primary endpoint will be 90 day mortality. Based on a 15% relative reduction in the primary endpoint, an alpha of 5% and a beta of 90% and an allowance for loss to follow up, the sample size is 5000 patients internationally (approx 700 patients will be enrolled by Irish sites).
The TRANSFUSE-RCT will be conducted by and Australian collaboration (the Australian Red Cross Blood Service, the Transfusion Outcomes Research Collaborative and the ANZICS-Clinical Trials Group)and an irish Collaboration, the Irish Society of Intensive Care- Clinical Trials Group and seven key Intensive Care Units in Ireland. This funding application is to support the infrastructure and patient enrollment TRANSFUSE in Ireland.
Only a large RCT can answer this critical question, which will have important health policy implications and rapid translation, regardless of the outcome, in Ireland, Australia and internationally.
