Phase 3
Completed N=1,538
Age of Blood in Children in Pediatric Intensive Care Units
Source: ClinicalTrials.gov NCT01977547 ↗Enrolled (actual)
1,538
Serious AEs
11.2%
Results posted
Apr 2021
Primary outcomePrimary: Number of Participants With New or Progressive Multiple Organ Dysfunction Syndrome (NPMODS) — 147; 133 Participants
◆ Published Evidence
Highly cited
105citations · ~15 / year
Effect of Fresh vs Standard-issue Red Blood Cell Transfusions on Multiple Organ Dysfunction Syndrome in Critically Ill Pediatric Patients: A Randomized Clinical Trial.
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).
Linked Publications (2)
-
Effect of Fresh vs Standard-issue Red Blood Cell Transfusions on Multiple Organ Dysfunction Syndrome in Critically Ill Pediatric Patients: A Randomized Clinical Trial.
-
The age of blood in pediatric intensive care units (ABC PICU): study protocol for a randomized controlled trial.
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 | — |
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.
OR
- 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.
OR
- 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
Data sourced from ClinicalTrials.gov (NCT01977547) and the linked publication. 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. Informational only — not medical advice.