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The age of blood in pediatric intensive care units (ABC PICU): study protocol for a randomized controlled trial
Marisa Tucci1,2, Jacques Lacroix3, Dean Fergusson4
1From the Division of Pediatric Critical Care Medicine, Department of Pediatrics, Sainte-Justine Hospital, Faculty of Medicine, Université de Montréal, Montréal, QC, Canada. marisa.tucci@recherche-ste-justine.qc.ca.
Insights
The Age of Blood in Children in Pediatric Intensive Care Unit (ABC PICU) study investigates if red blood cell storage age impacts outcomes in critically ill children. Findings will guide transfusion practices for pediatric intensive care unit patients.
Area of Science:
- Pediatric critical care medicine
- Transfusion medicine
- Hematology
Background:
- Red blood cell (RBC) storage duration and its impact on critically ill children remain controversial.
- Evidence suggests older RBC units may have reduced efficacy and safety, particularly in vulnerable pediatric populations.
- Current practices vary, with some favoring fresh RBCs while blood banks typically use the oldest available units to minimize waste.
Purpose of the Study:
- To determine if the storage age of red blood cell units affects clinical outcomes in critically ill children.
- To compare the incidence of New or Progressive Multiple Organ Dysfunction Syndrome (NPMODS) between children receiving fresh vs. standard-issue RBCs.
Main Methods:
- A double-blind superiority randomized controlled trial (RCT) involving 1538 critically ill children.
- Patients were randomized to receive either RBCs stored for ≤7 days or standard-issue (oldest) RBCs.
- Recruitment across 52 centers in the US, Canada, France, Italy, and Israel (ClinicalTrials.gov ID: NCT01977547).
Main Results:
- The study is ongoing and results are pending.
- A 33% relative risk reduction in NPMODS is postulated for the short-storage arm.
Conclusions:
- Study findings will significantly impact blood bank procurement and transfusion strategies for pediatric intensive care units.
- Results will either support the use of fresher RBCs for critically ill children or reassure clinicians about the safety of current allocation systems.
- The study aims to provide evidence-based guidance for optimizing RBC transfusion in pediatric critical care.
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.
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