• Trials · Jul 2018

    The age of blood in pediatric intensive care units (ABC PICU): study protocol for a randomized controlled trial.

    • Marisa Tucci, Jacques Lacroix, Dean Fergusson, Allan Doctor, Paul Hébert, Robert A Berg, Jaime Caro, Cassandra D Josephson, Stéphane Leteurtre, Kusum Menon, Kenneth Schechtman, Marie E Steiner, Alexis F Turgeon, Lucy Clayton, Tina Bockelmann, Philip C Spinella, Canadian Critical Care Trials Group, Pediatric Critical Care Blood Research Network (BloodNet), and Pediatric Acute Lung Injury and Sepsis Investigators (PALISI) Network.
    • From the Division of Pediatric Critical Care Medicine, Department of Pediatrics, Sainte-Justine Hospital, Faculty of Medicine, Université de Montréal, Montréal, QC, Canada. marisa.tucci@recherche-ste-justine.qc.ca.
    • Trials. 2018 Jul 28; 19 (1): 404.

    BackgroundThe "Age of Blood in Children in Pediatric Intensive Care Unit" (ABC PICU) study is a randomized controlled trial (RCT) that aims to determine if red blood cell (RBC) unit storage age affects outcomes in critically ill children. While RBCs can be stored for up to 42 days in additive solutions, their efficacy and safety after long-term storage have been challenged. Preclinical and clinical observational evidence suggests loss of efficacy and lack of safety of older RBC units, especially in more vulnerable populations such as critically ill children. Because there is a belief that shorter storage will improve outcomes, some physicians and institutions systematically transfuse fresh RBCs to children. Conversely, the standard practice of blood banks is to deliver the oldest available RBC unit (first-in, first-out policy) in order to decrease wastage.Methods/DesignThe ABC PICU study, is a double-blind superiority trial comparing the development of "New or Progressive Multiple Organ Dysfunction Syndrome" (NPMODS) in 1538 critically ill children randomized to either transfusion with RBCs stored for ≤ 7 days or to standard-issue RBCs (oldest in inventory). Patients are being recruited from 52 centers in the US, Canada, France, Italy, and Israel.DiscussionThe ABC PICU study should have significant implications for blood procurement services. A relative risk reduction of 33% is postulated in the short-storage arm. If a difference is found, this will indicate that fresher RBCs do improve outcomes in the pediatric intensive care unit population and would justify that use in critically ill children. If no difference is found, this will reassure clinicians and transfusion medicine specialists regarding the safety of the current system of allocating the oldest RBC unit in inventory and will discourage clinicians from preferentially requesting fresher blood for critically ill children.Trial RegistrationClinicalTrials.gov, ID: NCT01977547 . Registered on 6 November 2013.

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