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

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.

Keywords: Blood; Children; Critical care; Erythrocyte; Intensive care; Mortality; Randomized controlled trial; Red blood cell (RBC); Study protocol; Transfusion.

Conflict of interest statement

Ethics approval and consent to participate

Approval was obtained from the Institutional Review Board/Research Ethics Board (IRB/REB) of all participating sites and were in accordance with the institutional policies of the US Department of Health and Human Services in the US, provincial legislation in Canada, and appropriate entities in France, Italy, and Israel. IRB/REB approval of the ABC PICU protocol and consent forms was required prior to patient participation in the trial. Consent is sought from eligible patients if the child is old enough, parents and/or a surrogate decision-maker if pre-consent has not been obtained of if the child is too young.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests. The study sponsors and funders were not involved in the study design, collection or management. There are no contractual agreements that limit access for the investigators.

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Figures

Fig. 1

Screening, eligibility, consent, and randomization scenarios

Fig. 2

Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) Figure: schedule of enrollment, interventions, and assessments

Fig. 3

Intent-to-treat (ITT) analysis