Age of Blood in Children in Pediatric Intensive Care Units

NCT ID: NCT01977547

Last Updated: 2021-04-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1538 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2018-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Short storage

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

Group Type: ACTIVE_COMPARATOR

Short storage RBC age

Intervention Type: BIOLOGICAL

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

Standard issue

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

Group Type: ACTIVE_COMPARATOR

Short storage RBC age

Intervention Type: BIOLOGICAL

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

Interventions

Short storage RBC age

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

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

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

OR

2. 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

3. 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.

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 < 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
• 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

• Minimum Eligible Age: 3 Days
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

Ministere de la Sante et des Services Sociaux

OTHER

Sponsor Role: collaborator

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Philip C. Spinella, MD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine, St. Louis

Marisa Tucci, MD

Role: PRINCIPAL_INVESTIGATOR

Ste-Justine Hospital, Montreal

Locations

University of Alabama at Birmingham

Birmingham, Alabama, United States

Diamond Children's Medical Center

Tucson, Arizona, United States

Children's Hospital Los Angeles

Los Angeles, California, United States

Children's Hospital of Orange County

Orange, California, United States

University of California, San Francisco

San Francisco, California, United States

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

Aurora, Colorado, United States

UF Health Shands Children's Hospital

Gainesville, Florida, United States

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

Chicago, Illinois, United States

Lutheran General Hospital

Park Ridge, Illinois, United States

James Whitcomb Riley Hospital for Children

Indianapolis, Indiana, United States

Washington University School of Medicine

St Louis, Missouri, United States

Weill Cornell Medical College

New York, New York, United States

Golisano Children's Hospital at Strong

Rochester, New York, United States

Duke University

Durham, North Carolina, United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Nationwide Children's Hospital

Columbus, Ohio, United States

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Children's Medical Center Dallas

Dallas, Texas, United States

Texas Children's Hospital

Houston, Texas, United States

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, United States

Stollery Children's Hospital

Edmonton, Alberta, Canada

IWK Health Centre

Halifax, Nova Scotia, Canada

London Health Sciences Centre

London, Ontario, Canada

Children's Hospital of Eastern Ontario

Ottawa, Ontario, Canada

The Hospital for Sick Children

Toronto, Ontario, Canada

CHU Sainte Justine

Montreal, Quebec, Canada

Centre Hospitalier de I'Universite Laval

Québec, , Canada

Hôpital Necker-enfants

Paris, Malades Paris, France

Place Amélie Raba Léon

Bordeaux, , France

Hôpital Jeanne de Flandre

Lille, , France

Hôpital Mère Enfant

Nantes, , France

Hôpital Robert Debré

Paris, , France

Hôpital Universitaire Necker - Enfants Malades

Paris, , France

CHU Pontchaillou

Rennes, , France

Sheba Medical Center

Tel Litwinsky, , Israel

Meyer's Hospital

Florence, , Italy

Bamino Gesú

Rome, , Italy

Countries

United States; Canada; France; Israel; Italy

References

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.

Reference Type: DERIVED

PMID: 31821429 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 30055634 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

1U01HL116383-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

MOP 126113

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

201302030

Identifier Type: -

Identifier Source: org_study_id