Clinical trial NCT01977547: Age of Blood in Children in Pediatric Intensive Care Units
Official title: Age of Blood in Children in Pediatric Intensive Care Units
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anemia
Keywords: Red blood cell transfusions
Red blood cell storage age
Pediatrics
Critical Care
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
name: Canadian Institutes of Health Research (CIHR)
name: Ministere de la Sante et des Services Sociaux
First posted: 2013-11-06
Enrollment: 1538
Sex: ALL
Minimum age (years): 3
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: Patients are considered eligible to participate in the trial if one of the following occur:

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.

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 \< 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

Primary outcomes:
measure: Number of Participants With New or Progressive Multiple Organ Dysfunction Syndrome (NPMODS)
timeFrame: 28 days after randomization
Secondary outcomes:
measure: Organ Dysfunction
timeFrame: Up to 28 days after randomization.
measure: PELOD-2 Score
timeFrame: Up to 28 days after randomization.
measure: Nosocomial Infection
timeFrame: Up to 28 days after randomization.
measure: Sepsis, Severe Sepsis, Septic Shock
timeFrame: Up to 28 days after randomization.
measure: Acute Respiratory Distress Syndrome
timeFrame: Up to 28 days after randomization.
measure: Mechanical Ventilation
timeFrame: Up to 28 days after randomization.
measure: ICU Free Days
timeFrame: Up to 28 days after randomization
measure: Mortality
timeFrame: Up to 90 days after randomization
measure: Delirium
timeFrame: up to 72 hours post last study transfusion
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Tucson
country: United States
facility: Diamond Children's Medical Center
state: Arizona
city: Los Angeles
country: United States
facility: Children's Hospital Los Angeles
state: California
city: Orange
country: United States
facility: Children's Hospital of Orange County
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Aurora
country: United States
facility: The Children's Hospital and University of Colorado Denver School of Medicine
state: Colorado
city: Gainesville
country: United States
facility: UF Health Shands Children's Hospital
state: Florida
city: Chicago
country: United States
facility: Ann & Robert H. Lurie Children's Hospital of Chicago
state: Illinois
city: Park Ridge
country: United States
facility: Lutheran General Hospital
state: Illinois
city: Indianapolis
country: United States
facility: James Whitcomb Riley Hospital for Children
state: Indiana
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
city: Rochester
country: United States
facility: Golisano Children's Hospital at Strong
state: New York
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
city: Philadelphia
country: United States
facility: The Children's Hospital of Philadelphia
state: Pennsylvania
city: Dallas
country: United States
facility: Children's Medical Center Dallas
state: Texas
city: Houston
country: United States
facility: Texas Children's Hospital
state: Texas
city: Milwaukee
country: United States
facility: Children's Hospital of Wisconsin
state: Wisconsin
city: Edmonton
country: Canada
facility: Stollery Children's Hospital
state: Alberta
city: Halifax
country: Canada
facility: IWK Health Centre
state: Nova Scotia
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
city: Ottawa
country: Canada
facility: Children's Hospital of Eastern Ontario
state: Ontario
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
city: Montreal
country: Canada
facility: CHU Sainte Justine
state: Quebec
city: Quebec
country: Canada
facility: Centre Hospitalier de I'Universite Laval
city: Paris
country: France
facility: Hôpital Necker-enfants
state: Malades Paris
city: Bordeaux
country: France
facility: Place Amélie Raba Léon
city: Lille
country: France
facility: Hôpital Jeanne de Flandre
city: Nantes
country: France
facility: Hôpital Mère Enfant
city: Paris
country: France
facility: Hôpital Robert Debré
city: Paris
country: France
facility: Hôpital Universitaire Necker - Enfants Malades
city: Rennes
country: France
facility: CHU Pontchaillou
city: Tel HaShomer
country: Israel
facility: Sheba Medical Center
city: Florence
country: Italy
facility: Meyer's Hospital
city: Rome
country: Italy
facility: Bamino Gesú
Study officials:
affiliation: Washington University School of Medicine, St. Louis
name: Philip C. Spinella, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ste-Justine Hospital, Montreal
name: Marisa Tucci, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.