Age of Blood in Children in Pediatric Intensive Care Units
Condition: Anemia
Intervention: Short storage RBC age
Intervention description: IND obtained to cover the expiration date on the red blood cell unit
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 1538.0
Sex: All
Minimum age: 3 Days
Maximum age: 15 Years
Healthy volunteers: No
Keywords: Red blood cell transfusions; Red blood cell storage age; Pediatrics; Critical Care

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