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

• Type of Material: Article
• Authors: Marisa Tucci, University of Montreal; Jacques Lacroix, University of Montreal; Dean Fergusson, University of Ottawa; Allan Doctor, Washington University; Paul Hebert, University of Montreal; Robert A. Berg, University of Pennsylvania; Jaime Caro, McGill University; Cassandra D Josephson, Emory University; Stéphane Leteurtre, University of Lille; Kusum Menon, University of Ottawa; Kenneth Schechtman, Washington University; Marie E. Steiner, Univ Minnesota; Alexis F. Turgeon, Laval University; Lucy Clayton, University of Montreal; Tina Bockelmann, Washington University; Phillip C. Spinella, Washington University
• Language: English
• Date: 2018-07-28
• Publisher: BMC (part of Springer Nature)
• Publication Version: Final Published Version
• Copyright Statement: © 2018 The Author(s).
• License: Creative Commons Attribution 4.0 International
• Final Published Version (URL): http://dx.doi.org/10.1186/s13063-018-2809-y
• Title of Journal or Parent Work: Trials
• ISSN: 1745-6215
• Volume: 19
• Issue: 1
• Start Page: 404
• End Page: 404
• Grant/Funding Information: This study is funded by (1) The National Heart, Lung and Blood Institute (Grant #1U01HL116383-01), (2) The Canadian Institutes of Health Research (grant #126113), Ottawa, ON, Canada, (3) Comité National de la Recherche Clinique, Département de la Recherche Clinique et du Développement (DRCD), Assistance Publique – Hôpitaux de Paris, Ministère des Solidarités, de la Santé et de la Famille, France, (4) Ministère des Affaires Sociales et de la Santé, Paris, France (PHRC 14–0390), (5) Ministère de la Santé et des Services Sociaux de la Province de Québec, and (6) The Department of Pediatrics, Washington University in St. Louis, St. Louis, MO, USA.
• Keywords: METAANALYSIS; Blood; Critical care; CLINICAL-TRIALS; Transfusion; OUTCOMES; Medicine, Research & Experimental; Research & Experimental Medicine; Red blood cell (RBC); Intensive care; Erythrocyte; Life Sciences & Biomedicine; Science & Technology; MORTALITY; Children; CRITICALLY-ILL ADULTS; RED-CELL STORAGE; Randomized controlled trial; ORGAN DYSFUNCTION SYNDROME; Mortality; TRANSFUSION MEDICINE; Study protocol; SURVIVAL; DURATION
• Research Categories: Health Sciences, Pathology; Health Sciences, Epidemiology; Health Sciences, Medicine and Surgery

Abstract

Background: 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. Methods/design: 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. Discussion: 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. Trial registration: ClinicalTrials.gov, ID: NCT01977547. Registered on 6 November 2013.