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Programs

Principal Investigator(s)

Jacques LacroixPaul Hébert, Dean Fergusson and Alan Tinmouth

Coordinator(s)

Lucy Clayton

Status

Published

ABLE - Age of Blood Evaluation Study: a Multicenter Randomized Clinical Trial

Background: Laboratory studies and a few observational studies have raised the possibility that prolonged red cell storage adversely affect clinical outcomes.  In addition, there are no clinical data (or standards) that demonstrate that older stored red cells remain effective oxygen carriers or that prolonged red cell storage does not result in harms to vulnerable patients requiring blood transfusions. 

Hypothesis: We hypothesize that the transfusion of fresh leukoreduced red cells (stored for less than 8 days) will lead to a 5% or greater improvement in 90 day all cause mortality and clinically important decreases in morbidity in a vulnerable population of critically ill patients.   
 
Study Population: Critically ill adults in ICU who 1) have had a request for a first RBC unit transfusion during the first 7 days of their admission to the ICU, and 2) have an anticipated requirement for ongoing invasive and/or non-invasive (CPAP or BIPAP) mechanical ventilation exceeding 48 hours (as estimated by the attending physician) {both criteria must be filled}.

Study Design: Double-blind, multicentre, parallel, pragmatic randomized clinical trial (RCT).
Study Intervention:  Critically ill patients who require red cell transfusion during their ICU admission will be randomized to receive either 1) standard issue red cells; or 2) red cells stored less than 8 days issued by the local blood bank. All red cell will be allogeneic and will be prepared in accordance to international standards, including universal pre-storage leukoreduction. 

Outcomes: The primary outcome will be 90-day all-cause mortality.  The secondary outcomes are 1) other mortality rates ascertained at hospital and ICU discharge, as well as at 30-day and at 6 months; (2) decrease organ failure assessed using the multiple organ dysfunction scores; (3) decrease serious nosocomial infections; (4) adverse events. 

Sample Size: In a total of 2510 patients, we will be able to detect a 5% absolute risk reduction [from a baseline mortality rate of 25% to 20%] assuming an overall alpha = 0.05, beta = 0.2 and a non-compliance rate of 5%.  A priori subgroups will include: 1) cardiovascular diseases; 2) multiple trauma; 3) severe sepsis & septic shock; 4) acute respiratory distress syndrome.

Clinical significance: This study regardless of its findings will have significant implications on the duration of red cell storage.  A negative trial will reassure clinicians and blood bankers regarding the effectiveness and safety of prolonged storage.  A positive trial will require changes to the inventory management of red cells, and will also lead to further research to better understand the storage lesion and to develop better storage methods.

Co-Investigators

Deborah Cook, John Marshall, Lauralyn McIntyre, Jeannie Callum, Morris Blajchman, Alexis Turgeon, Pierre Tiberghien, Gilles Capellier, Timothy Walsh, Simon Stanworth, Leo van de Watering.