Age of Blood in Children in Pediatric Intensive Care Units

Anemia Clinical Trial

— ABC-PICU  

Official title:

Age of Blood in Children in Pediatric Intensive Care Units

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01977547
• Other study ID #: 201302030
• Secondary ID: 1U01HL116383-01M
• Status: Completed
• Phase: Phase 3
• Start date: January 2014
• Est. completion date: December 2018

Study information

• Verified date: April 2021
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1538
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 15 Years

Eligibility

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

Related Conditions & MeSH terms

• Anemia

Intervention

Biological:
• Short storage RBC age
IND obtained to cover the expiration date on the red blood cell unit

Locations

Country	Name	City	State
Canada	Stollery Children's Hospital	Edmonton	Alberta
Canada	IWK Health Centre	Halifax	Nova Scotia
Canada	London Health Sciences Centre	London	Ontario
Canada	CHU Sainte Justine	Montreal	Quebec
Canada	Children's Hospital of Eastern Ontario	Ottawa	Ontario
Canada	Centre Hospitalier de I'Universite Laval	Quebec
Canada	The Hospital for Sick Children	Toronto	Ontario
France	Place Amélie Raba Léon	Bordeaux
France	Hôpital Jeanne de Flandre	Lille
France	Hôpital Mère Enfant	Nantes
France	Hôpital Necker-enfants	Paris	Malades Paris
France	Hôpital Robert Debré	Paris
France	Hôpital Universitaire Necker - Enfants Malades	Paris
France	CHU Pontchaillou	Rennes
Israel	Sheba Medical Center	Tel HaShomer
Italy	Meyer's Hospital	Florence
Italy	Bamino Gesú	Rome
United States	The Children's Hospital and University of Colorado Denver School of Medicine	Aurora	Colorado
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Ann & Robert H. Lurie Children's Hospital of Chicago	Chicago	Illinois
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio
United States	Nationwide Children's Hospital	Columbus	Ohio
United States	Children's Medical Center Dallas	Dallas	Texas
United States	Duke University	Durham	North Carolina
United States	UF Health Shands Children's Hospital	Gainesville	Florida
United States	Texas Children's Hospital	Houston	Texas
United States	James Whitcomb Riley Hospital for Children	Indianapolis	Indiana
United States	Children's Hospital Los Angeles	Los Angeles	California
United States	Children's Hospital of Wisconsin	Milwaukee	Wisconsin
United States	Weill Cornell Medical College	New York	New York
United States	Children's Hospital of Orange County	Orange	California
United States	Lutheran General Hospital	Park Ridge	Illinois
United States	The Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	Golisano Children's Hospital at Strong	Rochester	New York
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	University of California, San Francisco	San Francisco	California
United States	Diamond Children's Medical Center	Tucson	Arizona

Sponsors (4)

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

Countries where clinical trial is conducted

United States,  Canada,  France,  Israel,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Organ Dysfunction	Difference in number of organ dysfunctions.	Up to 28 days after randomization.
Secondary	PELOD-2 Score	Difference in PELOD-2 score. Change from randomization to Worst PELOD-2 score. (Pediatric Logistic Organ Dysfunction) Points are on a range of 0-6 and based on Neurologic, cardiovascular, renal, respiratory, and hematologic function. The higher the score the worse the organ failure is and higher mortality rate.	Up to 28 days after randomization.
Secondary	Nosocomial Infection	Difference in nosocomial infection rate.	Up to 28 days after randomization.
Secondary	Sepsis, Severe Sepsis, Septic Shock	Difference in the rate of sepsis, severe sepsis or septic shock.	Up to 28 days after randomization.
Secondary	Acute Respiratory Distress Syndrome	Difference in the rate of acute respiratory distress syndrome.	Up to 28 days after randomization.
Secondary	Mechanical Ventilation	28 day mechanical ventilation free days	Up to 28 days after randomization.
Secondary	ICU Free Days	Difference in ICU free days.	Up to 28 days after randomization
Secondary	Mortality	Difference in 90 day mortality.	Up to 90 days after randomization
Secondary	Delirium	Transfusion Associated Delirium in pediatric critically ill children	up to 72 hours post last study transfusion