Age of Blood in Children in Pediatric Intensive Care Units

Completed · Phase 3

Conditions studied: Anemia

In brief

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).

Key facts

Study ID

NCT01977547

Run by

Washington University School of Medicine

People needed

1538

Starts

2014-01-01

Expected to finish

2018-12-01

Last updated by the study team

2021-04-29

Who can join

Age: 0 and older, up to 15. Sex: any. Healthy volunteers: not accepted.

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
• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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