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Summary

for people ages up to 15 years (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

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).

Keywords

Anemia Red blood cell transfusions Red blood cell storage age Pediatrics Critical Care

Eligibility

For people ages up to 15 years

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

Locations

  • Children's Hospital Los Angeles accepting new patients
    Los Angeles, California, 90027, United States
  • Children's Hospital of Orange County accepting new patients
    Orange, California, 92868, United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Washington University School of Medicine
ID
NCT01977547
Phase
Phase 3
Lead Scientist
Patrick Mcquillen
Study Type
Interventional
Last Updated
April 1, 2017
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