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Age of Blood in Children in Pediatric Intensive Care Units

NCT01977547 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1538

Last updated 2021-04-29

Study results available
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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).

Conditions

Interventions

BIOLOGICAL

Short storage RBC age

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

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV

  • Ministere de la Sante et des Services Sociaux

    collaborator OTHER

  • Washington University School of Medicine

    lead OTHER

Principal Investigators

  • Philip C. Spinella, MD · Washington University School of Medicine, St. Louis

  • Marisa Tucci, MD · Ste-Justine Hospital, Montreal

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
3 Days
Max Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2018-12-31
Completion
2018-12-31

Countries

  • United States
  • Canada
  • France
  • Israel
  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01977547 on ClinicalTrials.gov