Age of Blood in Children in Pediatric Intensive Care Units (ABC PICU)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Washington University School of Medicine
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Ministere de la Sante et des Services Sociaux
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01977547
First received: August 9, 2013
Last updated: September 4, 2014
Last verified: September 2014
  Purpose

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).


Condition Intervention Phase
Anemia
Biological: Short storage RBC age
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Age of Blood in Children in Pediatric Intensive Care Units

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • New or Progressive Multiple Organ Dysfunction Syndrome (NPMODS) [ Time Frame: 28 days after randomization ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Organ dysfunction [ Time Frame: Up to 28 days after randomization. ] [ Designated as safety issue: No ]
    Difference in number of organ dysfunctions.

  • PELOD-2 score [ Time Frame: Up to 28 days after randomization. ] [ Designated as safety issue: No ]
    Difference in PELOD-2 score.

  • Nosocomial infection [ Time Frame: Up to 28 days after randomization. ] [ Designated as safety issue: No ]
    Difference in nosocomial infection rate.

  • Sepsis, severe sepsis, septic shock [ Time Frame: Up to 28 days after randomization. ] [ Designated as safety issue: No ]
    Difference in the rate of sepsis, severe sepsis or septic shock.

  • Acute Respiratory Distress Syndrome [ Time Frame: Up to 28 days after randomization. ] [ Designated as safety issue: No ]
    Difference in the rate of acute respiratory distress syndrome.

  • Mechanical ventilation [ Time Frame: Up to 28 days after randomization. ] [ Designated as safety issue: No ]
    Difference in the duration of mechanical ventilation and ventilation free days.

  • ICU free days [ Time Frame: Up to 28 days after randomization ] [ Designated as safety issue: No ]
    Difference in ICU free days.

  • Mortality [ Time Frame: Up to 90 days after randomization ] [ Designated as safety issue: No ]
    Difference in 90 day mortality.


Estimated Enrollment: 1538
Study Start Date: January 2014
Estimated Study Completion Date: August 2018
Estimated Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Short storage
Red blood cells storage duration of equal to or less than 7 days.
Biological: Short storage RBC age
IND obtained to cover the expiration date on the red blood cell unit
Active Comparator: Standard issue
Red blood cells storage duration of 2 to 42 days with an expected average length of storage of about 17-21 days.
Biological: Short storage RBC age
IND obtained to cover the expiration date on the red blood cell unit

  Eligibility

Ages Eligible for Study:   up to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  • Pregnant
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01977547

Contacts
Contact: Rachel Jacobs, BA 314-747-5584 jacobs_r@kids.wustl.edu
Contact: Lucy Clayton, M.Sc. 514 345-4931 ext 6816 lucy.clayton@recherche-ste-justine.qc.ca

  Show 38 Study Locations
Sponsors and Collaborators
Washington University School of Medicine
Canadian Institutes of Health Research (CIHR)
Ministere de la Sante et des Services Sociaux
Investigators
Principal Investigator: Philip C. Spinella, MD Washington University School of Medicine, St. Louis
Principal Investigator: Marisa Tucci, MD Ste-Justine Hospital, Montreal
  More Information

No publications provided

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01977547     History of Changes
Other Study ID Numbers: 201302030, 1U01HL116383-01, MOP 126113
Study First Received: August 9, 2013
Last Updated: September 4, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board
Canada: Ethics Review Committee

Keywords provided by Washington University School of Medicine:
Red blood cell transfusions
Red blood cell storage age
Pediatrics
Critical Care

ClinicalTrials.gov processed this record on October 21, 2014