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

• Published in: Current controlled trials in cardiovascular medicine 2018-07, Vol.19 (1), p.404-404, Article 404
• Main Authors: Tucci, Marisa, Lacroix, Jacques, Fergusson, Dean, Doctor, Allan, Hébert, Paul, Berg, Robert A, Caro, Jaime, Josephson, Cassandra D, Leteurtre, Stéphane, Menon, Kusum, Schechtman, Kenneth, Steiner, Marie E, Turgeon, Alexis F, Clayton, Lucy, Bockelmann, Tina, Spinella, Philip C
• Format: Article
• Language: English
• Subjects: Adolescent; Age; Analysis; Blood; Blood banks; Blood clotting; Blood Preservation - adverse effects; Blood Preservation - methods; Blood Preservation - mortality; Blood products; Brain death; Canada; Child; Child, Preschool; Children; Clinical trials; Critical care; Critical Illness; Double-Blind Method; Erythrocyte; Erythrocyte Transfusion - adverse effects; Erythrocyte Transfusion - mortality; Erythrocytes; Europe; Extracorporeal membrane oxygenation; Female; Health aspects; Hospital Mortality; Humans; Infant; Infant, Newborn; Intensive care; Intensive care units; Intensive Care Units, Pediatric; Israel; Life Sciences; Male; Mortality; Multicenter Studies as Topic; Multiple organ dysfunction syndrome; Multiple Organ Failure - diagnosis; Multiple Organ Failure - etiology; Multiple Organ Failure - mortality; Multiple Organ Failure - prevention & control; Observational studies; Patients; Pediatrics; Randomized Controlled Trials as Topic; Red blood cell (RBC); Registration; Risk Assessment; Risk Factors; Study Protocol; Time Factors; Treatment Outcome; United States
• ISSN: 1745-6215; 1745-6215
• DOI: 10.1186/s13063-018-2809-y

The "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. The 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. The 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. ClinicalTrials.gov, ID: NCT01977547 . Registered on 6 November 2013.