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,
for the Canadian Critical Care Trials Group,
the Pediatric Critical Care Blood Research Network (BloodNet),
the Pediatric Acute Lung Injury and Sepsis Investigators (PALISI) Network
Affiliations
Marisa Tucci
From the Division of Pediatric Critical Care Medicine, Department of Pediatrics, Sainte-Justine Hospital, Faculty of Medicine, Université de Montréal
Jacques Lacroix
From the Division of Pediatric Critical Care Medicine, Department of Pediatrics, Sainte-Justine Hospital, Faculty of Medicine, Université de Montréal
Dean Fergusson
Clinical Epidemiology Program, Ottawa Hospital Research Institute and Faculty of Medicine, University of Ottawa
Allan Doctor
Division of Critical Care, Department of Pediatrics, Washington University in St. Louis
Paul Hébert
Division of Critical Care Medicine, Department of Medicine, Montreal University Health Center, Faculty of Medicine, Université de Montréal
Robert A. Berg
Division of Pediatric Critical Care Medicine, Department of Anesthesiology and Critical Care Medicine, Children’s Hospital of Philadelphia, Faculty of Medicine, University of Pennsylvania
Jaime Caro
Department of Epidemiology, Biostatistics and Occupational Health, Faculty of Medicine, McGill University
Cassandra D. Josephson
Departments of Pathology and Pediatrics, Emory University School of Medicine and Children’s Healthcare of Atlanta
Stéphane Leteurtre
University of Lille, CHU Lille, EA 2694 – Santé Publique : épidémiologie et qualité des soins
Kusum Menon
Division of Pediatric Critical Care Medicine, Department of Pediatrics, Children’s Hospital of Eastern Ontario, Faculty of Medicine, University of Ottawa
Kenneth Schechtman
Clinical Epidemiology Program, St. Louis Children’s Hospital, Faculty of Medicine, Washington University School of Medicine
Marie E. Steiner
Division of Pediatric Hematology-Oncology and Division of Pulmonary and Critical Care, Department of Pediatrics, University of Minnesota
Alexis F. Turgeon
Division of Critical Care Medicine, Department of Anesthesiology and Critical Care Medicine, and CHU de Québec-Université Laval Research Centre, Population Health and Optimal Health Practices Unit, Université Laval
Lucy Clayton
From the Clinical Research Unit, Research Center, Sainte-Justine Hospital, Université de Montréal
Tina Bockelmann
Division of Critical Care, Department of Pediatrics, Washington University in St. Louis
Philip C. Spinella
Division of Critical Care, Department of Pediatrics, Washington University in St. Louis
for the Canadian Critical Care Trials Group
the Pediatric Critical Care Blood Research Network (BloodNet)
the Pediatric Acute Lung Injury and Sepsis Investigators (PALISI) Network
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.
