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Trial record 1 of 1 for:    NCT01977547
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Age of Blood in Children in Pediatric Intensive Care Units (ABC PICU)

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ClinicalTrials.gov Identifier: NCT01977547
Recruitment Status : Recruiting
First Posted : November 6, 2013
Last Update Posted : October 2, 2018
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
Canadian Institutes of Health Research (CIHR)
Ministere de la Sante et des Services Sociaux
Information provided by (Responsible Party):
Washington University School of Medicine

Tracking Information
First Submitted Date  ICMJE August 9, 2013
First Posted Date  ICMJE November 6, 2013
Last Update Posted Date October 2, 2018
Study Start Date  ICMJE January 2014
Actual Primary Completion Date July 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 30, 2013)
New or Progressive Multiple Organ Dysfunction Syndrome (NPMODS) [ Time Frame: 28 days after randomization ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01977547 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 19, 2017)
  • Organ dysfunction [ Time Frame: Up to 28 days after randomization. ]
    Difference in number of organ dysfunctions.
  • PELOD-2 score [ Time Frame: Up to 28 days after randomization. ]
    Difference in PELOD-2 score.
  • Nosocomial infection [ Time Frame: Up to 28 days after randomization. ]
    Difference in nosocomial infection rate.
  • Sepsis, severe sepsis, septic shock [ Time Frame: Up to 28 days after randomization. ]
    Difference in the rate of sepsis, severe sepsis or septic shock.
  • Acute Respiratory Distress Syndrome [ Time Frame: Up to 28 days after randomization. ]
    Difference in the rate of acute respiratory distress syndrome.
  • Mechanical ventilation [ Time Frame: Up to 28 days after randomization. ]
    Difference in the duration of mechanical ventilation and ventilation free days.
  • ICU free days [ Time Frame: Up to 28 days after randomization ]
    Difference in ICU free days.
  • Mortality [ Time Frame: Up to 90 days after randomization ]
    Difference in 90 day mortality.
  • Delirium [ Time Frame: up to 72 hours post last study transfusion ]
    Transfusion Associated Delirium in pediatric critically ill children
Original Secondary Outcome Measures  ICMJE
 (submitted: October 30, 2013)
  • Organ dysfunction [ Time Frame: Up to 28 days after randomization. ]
    Difference in number of organ dysfunctions.
  • PELOD-2 score [ Time Frame: Up to 28 days after randomization. ]
    Difference in PELOD-2 score.
  • Nosocomial infection [ Time Frame: Up to 28 days after randomization. ]
    Difference in nosocomial infection rate.
  • Sepsis, severe sepsis, septic shock [ Time Frame: Up to 28 days after randomization. ]
    Difference in the rate of sepsis, severe sepsis or septic shock.
  • Acute Respiratory Distress Syndrome [ Time Frame: Up to 28 days after randomization. ]
    Difference in the rate of acute respiratory distress syndrome.
  • Symptomatic deep vein thrombosis [ Time Frame: Up to 28 days after randomization. ]
    Difference in the rate of symptomatic deep vein thrombosis.
  • Transfusion reaction [ Time Frame: Up to 28 days after randomization. ]
    Difference in the rate of transfusion reactions.
  • Mechanical ventilation [ Time Frame: Up to 28 days after randomization. ]
    Difference in the duration of mechanical ventilation and ventilation free days.
  • Hemodynamic support [ Time Frame: Up to 28 days after randomization. ]
    Difference in the use of hemodynamic support (vasoactive drugs or extracorporeal support).
  • Renal replacement therapy [ Time Frame: Up to 28 days after randomization. ]
    Difference in the use of renal replacement therapy.
  • ICU free days [ Time Frame: Up to 28 days after randomization ]
    Difference in ICU free days.
  • ICU re-admission [ Time Frame: Up to 90 days after randomization ]
    Difference in the rate of ICU re-admission.
  • Mortality [ Time Frame: Up to 90 days after randomization ]
    Difference in 90 day mortality.
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Age of Blood in Children in Pediatric Intensive Care Units
Official Title  ICMJE Age of Blood in Children in Pediatric Intensive Care Units
Brief 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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Anemia
Intervention  ICMJE Biological: Short storage RBC age
IND obtained to cover the expiration date on the red blood cell unit
Study Arms
  • Active Comparator: Short storage
    Red blood cells storage duration of equal to or less than 7 days.
    Intervention: Biological: Short storage RBC age
  • 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.
    Intervention: Biological: Short storage RBC age
Publications * Tucci M, Lacroix J, Fergusson D, Doctor A, Hébert P, Berg RA, Caro J, Josephson CD, Leteurtre S, Menon K, Schechtman K, Steiner ME, Turgeon AF, Clayton L, Bockelmann T, Spinella PC; Canadian Critical Care Trials Group; Pediatric Critical Care Blood Research Network (BloodNet); Pediatric Acute Lung Injury and Sepsis Investigators (PALISI) Network. The age of blood in pediatric intensive care units (ABC PICU): study protocol for a randomized controlled trial. Trials. 2018 Jul 28;19(1):404. doi: 10.1186/s13063-018-2809-y.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 30, 2013)
1538
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date December 2018
Actual Primary Completion Date July 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender
Sexes Eligible for Study: All
Ages up to 15 Years   (Child)
Accepts Healthy Volunteers No
Contacts  ICMJE
Contact: Tina Bockelmann, MSW 314-747-5584 ABCPICU@kids.wustl.edu
Contact: Lucy Clayton, M.Sc. 514 345-4931 ext 6816 lucy.clayton@recherche-ste-justine.qc.ca
Listed Location Countries  ICMJE Canada,   France,   Israel,   Italy,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01977547
Other Study ID Numbers  ICMJE 201302030
1U01HL116383-01 ( U.S. NIH Grant/Contract )
MOP 126113 ( Other Grant/Funding Number: Canadian Institutes of Health Research (CIHR) )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Washington University School of Medicine
Study Sponsor  ICMJE Washington University School of Medicine
Collaborators  ICMJE
  • National Heart, Lung, and Blood Institute (NHLBI)
  • Canadian Institutes of Health Research (CIHR)
  • Ministere de la Sante et des Services Sociaux
Investigators  ICMJE
Principal Investigator: Philip C. Spinella, MD Washington University School of Medicine, St. Louis
Principal Investigator: Marisa Tucci, MD Ste-Justine Hospital, Montreal
PRS Account Washington University School of Medicine
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP