Age of Blood in Children in Pediatric Intensive Care Units

NCT01977547 | Completed Phase 3 Results DMC

• 3 other identifiers: 2013020301U01HL116383-01MOP 126113
• Study Type: interventional
• Target: 1,538
• Locations: 5 countries
• Sites: 37

Brief 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

Anemia

Keywords

Red blood cell transfusions; Red blood cell storage age; Pediatrics; Critical Care

Outcome Measures

Primary Outcomes (1)

• Number of Participants With New or Progressive Multiple Organ Dysfunction Syndrome (NPMODS)

  The primary outcome measure of this RCT is NPMODS defined as the proportion of patients who die during the 28 days after randomization or who develop NPMODS. For patients with no organ dysfunction at randomization, New MODS is the development of ≥ 2 concurrent organ dysfunctions during the 28 days after randomization. For patients with 1 organ dysfunction at randomization, New MODS is the development of at least 1 other concurrent organ dysfunction after randomization. Patients with MODS (ie concurrent dysfunction of ≥ 2 organ systems) at randomization can develop Progressive MODS defined as development of at least 1 additional concurrent organ dysfunction at during the 28 days after randomization. All deaths will be considered Progressive MODS. NPMODS will be monitored up to 28 days or ICU discharge because it is almost never observed beyond this time in children.

  28 days after randomization

Secondary Outcomes (9)

• Organ Dysfunction

  Up to 28 days after randomization.

• PELOD-2 Score

  Up to 28 days after randomization.

• Nosocomial Infection

  Up to 28 days after randomization.

• Sepsis, Severe Sepsis, Septic Shock

  Up to 28 days after randomization.

• Acute Respiratory Distress Syndrome

  Up to 28 days after randomization.

Study Arms (2)

Short storage

ACTIVE COMPARATOR

Red blood cells storage duration of equal to or less than 7 days.

Biological: Short storage RBC age

Standard issue

ACTIVE COMPARATOR

Red blood cells storage duration of 2 to 42 days with an expected average length of storage of about 17-21 days.

Biological: Short storage RBC age

Interventions

Short storage RBC age BIOLOGICAL

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

Short storage; Standard issue

Eligibility Criteria

• Age: 3 Days - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Age at time of enrollment \< 3 days from birth or has reached their 16th birthday.
• Post-conception age \< 36 weeks at time of enrollment
• Documented RBC transfusion within the 28 days prior to fulfilling the eligibility criteria
• Previously randomized in this study
• Weight \< 3.0 kg on ICU admission
• Known Pregnancy
• Conscious objection or unwillingness to receive blood products
• Not expected to survive beyond 24 hours, brain death or suspected brain death
• Limitation or withdrawal of care decisions have been made
• Enrollment in another randomized clinical trial which has not been approved for co-enrollment
• Patients for whom autologous and/or directed donation RBCs will be provided
• Patients for whom the treating physician routinely and systematically requests RBC ≤ 14 days of storage
• Patients for whom there systematically exist RBC aliquoting policies that mandate the initial use of units stored ≤ 14 days (ex: Pedi-Pack).
• On ECMO or plan to be immediately placed on ECMO at time of enrollment
• Patient predicted or presumed to require a massive transfusion (\> 40ml/kg of all blood components in a 24 hour period) according to treating physician judgment

Sponsors & Collaborators

• Washington University School of Medicine: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• Canadian Institutes of Health Research (CIHR): collaborator
• Ministere de la Sante et des Services Sociaux: collaborator

Study Sites (37)

University of Alabama at Birmingham

Birmingham, Alabama, 35223, United States

Location

Diamond Children's Medical Center

Tucson, Arizona, 85721, United States

Location

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

Location

Children's Hospital of Orange County

Orange, California, 92868, United States

Location

University of California, San Francisco

San Francisco, California, 94143, United States

Location

The Children's Hospital and University of Colorado Denver School of Medicine

Aurora, Colorado, 80045, United States

Location

UF Health Shands Children's Hospital

Gainesville, Florida, United States

Location

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, 60611, United States

Location

Lutheran General Hospital

Park Ridge, Illinois, United States

Location

James Whitcomb Riley Hospital for Children

Indianapolis, Indiana, 46202, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Weill Cornell Medical College

New York, New York, 10065, United States

Location

Golisano Children's Hospital at Strong

Rochester, New York, 14642, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Children's Medical Center Dallas

Dallas, Texas, 75390, United States

Location

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Stollery Children's Hospital

Edmonton, Alberta, T6G 2B7, Canada

Location

IWK Health Centre

Halifax, Nova Scotia, B3K 6R8, Canada

Location

London Health Sciences Centre

London, Ontario, N6A 5W9, Canada

Location

Children's Hospital of Eastern Ontario

Ottawa, Ontario, K1H 8L1, Canada

Location

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

CHU Sainte Justine

Montreal, Quebec, H3T 1C5, Canada

Location

Centre Hospitalier de I'Universite Laval

Québec, G1V 4G2, Canada

Location

Hôpital Necker-enfants

Paris, Malades Paris, 75015, France

Location

Place Amélie Raba Léon

Bordeaux, 33076, France

Location

Hôpital Jeanne de Flandre

Lille, 59037, France

Location

Hôpital Mère Enfant

Nantes, 44093, France

Location

Hôpital Robert Debré

Paris, 75019, France

Location

Hôpital Universitaire Necker - Enfants Malades

Paris, 75743, France

Location

CHU Pontchaillou

Rennes, 35033, France

Location

Sheba Medical Center

Tel Litwinsky, Israel

Location

Meyer's Hospital

Florence, Italy

Location

Bamino Gesú

Rome, 00165, Italy

Location

Related Publications (2)

• Spinella PC, Tucci M, Fergusson DA, Lacroix J, Hebert PC, Leteurtre S, Schechtman KB, Doctor A, Berg RA, Bockelmann T, Caro JJ, Chiusolo F, Clayton L, Cholette JM, Guerra GG, Josephson CD, Menon K, Muszynski JA, Nellis ME, Sarpal A, Schafer S, Steiner ME, Turgeon AF; ABC-PICU Investigators, the Canadian Critical Care Trials Group, the Pediatric Acute Lung Injury and Sepsis Investigators Network, the BloodNet Pediatric Critical Care Blood Research Network, and the Groupe Francophone de Reanimation et Urgences P. Effect of Fresh vs Standard-issue Red Blood Cell Transfusions on Multiple Organ Dysfunction Syndrome in Critically Ill Pediatric Patients: A Randomized Clinical Trial. JAMA. 2019 Dec 10;322(22):2179-2190. doi: 10.1001/jama.2019.17478.

  PMID: 31821429 DERIVED

• Tucci M, Lacroix J, Fergusson D, Doctor A, Hebert P, Berg RA, Caro J, Josephson CD, Leteurtre S, Menon K, Schechtman K, Steiner ME, Turgeon AF, Clayton L, Bockelmann T, Spinella PC; Canadian Critical Care Trials Group; Pediatric Critical Care Blood Research Network (BloodNet); Pediatric Acute Lung Injury and Sepsis Investigators (PALISI) Network. The age of blood in pediatric intensive care units (ABC PICU): study protocol for a randomized controlled trial. Trials. 2018 Jul 28;19(1):404. doi: 10.1186/s13063-018-2809-y.

  PMID: 30055634 DERIVED

MeSH Terms

Conditions

Anemia

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Results Point of Contact

• Title: Dr. Philip C. Spinella
• Organization: Washington University School of Medicine

pspinella@wustl.edu

3142860858

Study Officials

• Philip C. Spinella, MD

  Washington University School of Medicine, St. Louis

  PRINCIPAL INVESTIGATOR

• Marisa Tucci, MD

  Ste-Justine Hospital, Montreal

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2013
• First Posted: November 6, 2013
• Study Start: January 1, 2014
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: April 29, 2021
• Results First Posted: April 29, 2021

Record last verified: 2021-04

Locations

FR (7); IL (1); IT (2); US (20); CA (7)