Phase 3 N=1,538 Randomized Triple-blind Treatment

Age of Blood in Children in Pediatric Intensive Care Units

Anemia

Bottom Line

View on ClinicalTrials.gov: NCT01977547 ↗

Enrolled (actual)

1,538

Serious AEs

11.2%

Results posted

Apr 2021

Primary outcome: Primary: Number of Participants With New or Progressive Multiple Organ Dysfunction Syndrome (NPMODS) — 147; 133 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Short storage RBC age (Biological)
Age: Pediatric · 0+ yrs
Sex: All
Sponsor: Washington University School of Medicine
Primary completion: Dec 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With New or Progressive Multiple Organ Dysfunction Syndrome (NPMODS)	147; 133	—
SECONDARY Organ Dysfunction	129; 133	—
SECONDARY PELOD-2 Score	0.5; -0.05	—
SECONDARY Nosocomial Infection	24; 23	—
SECONDARY Sepsis, Severe Sepsis, Septic Shock	160; 154; 63; 60; 59; 57	—
SECONDARY Acute Respiratory Distress Syndrome	41; 29	—
SECONDARY Mechanical Ventilation	25.4; 25.8	—
SECONDARY ICU Free Days	21.9; 22.0	—
SECONDARY Mortality	49; 45	—
SECONDARY Delirium	55; 54	—

Summary

ABC PICU is a randomized clinical trial that will compare the clinical consequences of RBC storage duration in 1538 critically ill children. Laboratory and observational evidence points to serious concerns about the lack of safety and effectiveness of older RBCs, especially in more vulnerable populations. Physicians and institutions have been systematically transfusing fresh RBCs to some pediatric patients primarily because of beliefs that the use of fresh RBCs improve outcomes. Conversely, the standard practice of blood banks is to deliver the oldest RBC unit in order to decrease blood wastage. To provide much needed high quality evidence to answer the question "do RBCs of reduced storage duration improve outcomes?" The ABC PICU Trial will conduct a RCT comparing development of New or Progressive Multiple Organ Dysfunction Syndrome (NPMODS) in critically ill children transfused with either RBCs stored ≤ 7 days or standard issue RBCs (expected mean RBC storage duration of 17-21 days).

Eligibility Criteria

Patients are considered eligible to participate in the trial if one of the following occur:

First RBC transfusion is requested within the first 7 days (168 hours) of ICU admission.

First RBC transfusion is requested for a patient in the Emergency Room, and the PICU team is involved with the clinical care of the patient, and the patient will definitively be transferred to the ICU.

Patient assessed pre-operatively and for whom ICU admission is planned post-operatively, and who is determined to definitively require a first RBC transfusion during surgery.

Inclusion Criteria

Eligible critically ill pediatric patients who have an expected length of stay after transfusion in the ICU > 24 hours based on the best judgment of the attending ICU staff.

Exclusion Criteria

Age at time of enrollment 40ml/kg of all blood components in a 24 hour period) according to treating physician judgment
Refusal by physician
Inability to obtain consent
Blood bank personnel experiences difficulties in securing blood products (difficult cross matches, rare blood groups and diseases like IgA deficiency)
Insufficient number of ABO type compatible RBC units available in the blood bank at randomization with a storage time ≤ 7 days (minimum 1 unit regardless of patient age)
All RBC units available for the patient are not leukocyte-reduced prior to storage

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01977547). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.