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

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 solu...

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Autores principales: 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.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6064163/
https://www.ncbi.nlm.nih.gov/pubmed/30055634
http://dx.doi.org/10.1186/s13063-018-2809-y
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author 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.
author_facet 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.
author_sort Tucci, Marisa
collection PubMed
description 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. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1186/s13063-018-2809-y) contains supplementary material, which is available to authorized users.
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spelling pubmed-60641632018-08-01 The age of blood in pediatric intensive care units (ABC PICU): study protocol for a randomized controlled trial 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. Trials Study Protocol 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. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1186/s13063-018-2809-y) contains supplementary material, which is available to authorized users. BioMed Central 2018-07-28 /pmc/articles/PMC6064163/ /pubmed/30055634 http://dx.doi.org/10.1186/s13063-018-2809-y Text en © The Author(s). 2018 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
spellingShingle Study Protocol
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.
The age of blood in pediatric intensive care units (ABC PICU): study protocol for a randomized controlled trial
title The age of blood in pediatric intensive care units (ABC PICU): study protocol for a randomized controlled trial
title_full The age of blood in pediatric intensive care units (ABC PICU): study protocol for a randomized controlled trial
title_fullStr The age of blood in pediatric intensive care units (ABC PICU): study protocol for a randomized controlled trial
title_full_unstemmed The age of blood in pediatric intensive care units (ABC PICU): study protocol for a randomized controlled trial
title_short The age of blood in pediatric intensive care units (ABC PICU): study protocol for a randomized controlled trial
title_sort age of blood in pediatric intensive care units (abc picu): study protocol for a randomized controlled trial
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6064163/
https://www.ncbi.nlm.nih.gov/pubmed/30055634
http://dx.doi.org/10.1186/s13063-018-2809-y
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