CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,538 enrolled
Drug / intervention
Short storage RBC agebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01977547
NCT01977547Phase 3Completed

Age of Blood in Children in Pediatric Intensive Care Units

Washington University School of Medicine·interventional·Posted Nov 6, 2013·Updated Apr 29, 2021

In Brief

A Phase 3 clinical trial evaluating Short storage RBC age for Anemia. Completed, enrolled 1,538 participants across 37 sites in 5 countries.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAnemia
CountriesCanada, France, Israel, Italy, United States

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedNov 6, 2013
Enrollment StartJan 1, 2014
Primary CompletionDec 1, 2018
TodayJul 2, 2026
Enrollment to primary: 4.9 yearsPosted 12.7 years ago

Interventions

Short storage RBC agebiological

IND obtained to cover the expiration date on the red blood cell unit