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Trials
Published in: Trials 1/2018

Open Access 01-12-2018 | Study protocol

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

Authors: 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

Published in: Trials | Issue 1/2018

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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.
Appendix
Available only for authorised users
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Metadata
Title
The age of blood in pediatric intensive care units (ABC PICU): study protocol for a randomized controlled trial
Authors
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
Publication date
01-12-2018
Publisher
BioMed Central
Published in
Trials / Issue 1/2018
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-018-2809-y

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