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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

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).

Condition or disease Intervention/treatment Phase
Anemia Biological: Short storage RBC age Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1538 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Age of Blood in Children in Pediatric Intensive Care Units
Study Start Date : January 2014
Actual Primary Completion Date : July 2018
Estimated Study Completion Date : December 2018

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Organ dysfunction [ Time Frame: Up to 28 days after randomization. ]
    Difference in number of organ dysfunctions.

  2. PELOD-2 score [ Time Frame: Up to 28 days after randomization. ]
    Difference in PELOD-2 score.

  3. Nosocomial infection [ Time Frame: Up to 28 days after randomization. ]
    Difference in nosocomial infection rate.

  4. Sepsis, severe sepsis, septic shock [ Time Frame: Up to 28 days after randomization. ]
    Difference in the rate of sepsis, severe sepsis or septic shock.

  5. Acute Respiratory Distress Syndrome [ Time Frame: Up to 28 days after randomization. ]
    Difference in the rate of acute respiratory distress syndrome.

  6. Mechanical ventilation [ Time Frame: Up to 28 days after randomization. ]
    Difference in the duration of mechanical ventilation and ventilation free days.

  7. ICU free days [ Time Frame: Up to 28 days after randomization ]
    Difference in ICU free days.

  8. Mortality [ Time Frame: Up to 90 days after randomization ]
    Difference in 90 day mortality.

  9. Delirium [ Time Frame: up to 72 hours post last study transfusion ]
    Transfusion Associated Delirium in pediatric critically ill children



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 15 Years   (Child)
Sexes Eligible for Study:   All
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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01977547


Contacts
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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

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Locations
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United States, Alabama
University of Alabama at Birmingham Completed
Birmingham, Alabama, United States, 35223
United States, Arizona
Diamond Children's Medical Center Completed
Tucson, Arizona, United States, 85721
United States, California
Children's Hospital Los Angeles Completed
Los Angeles, California, United States, 90027
Children's Hospital of Orange County Completed
Orange, California, United States, 92868
University of California, San Francisco Completed
San Francisco, California, United States, 94143
United States, Colorado
The Children's Hospital and University of Colorado Denver School of Medicine Completed
Aurora, Colorado, United States, 80045
United States, Florida
UF Health Shands Children's Hospital Completed
Gainesville, Florida, United States
United States, Illinois
Ann & Robert H. Lurie Children's Hospital of Chicago Completed
Chicago, Illinois, United States, 60611
Lutheran General Hospital Completed
Park Ridge, Illinois, United States
United States, Indiana
James Whitcomb Riley Hospital for Children Completed
Indianapolis, Indiana, United States, 46202
United States, Missouri
Washington University School of Medicine Completed
Saint Louis, Missouri, United States, 63110
United States, New York
Weill Cornell Medical College Completed
New York, New York, United States, 10065
Golisano Children's Hospital at Strong Completed
Rochester, New York, United States, 14642
United States, North Carolina
Duke University Completed
Durham, North Carolina, United States, 27710
United States, Ohio
Cincinnati Children's Hospital Medical Center Completed
Cincinnati, Ohio, United States, 45229
Nationwide Children's Hospital Completed
Columbus, Ohio, United States, 43205
United States, Pennsylvania
The Children's Hospital of Philadelphia Completed
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
Children's Medical Center Dallas Completed
Dallas, Texas, United States, 75390
Texas Children's Hospital Completed
Houston, Texas, United States, 77030
United States, Wisconsin
Children's Hospital of Wisconsin Completed
Milwaukee, Wisconsin, United States, 53226
Canada, Alberta
Stollery Children's Hospital Completed
Edmonton, Alberta, Canada, T6G 2B7
Canada, Nova Scotia
IWK Health Centre Not yet recruiting
Halifax, Nova Scotia, Canada, B3K 6R8
Canada, Ontario
London Health Sciences Centre Completed
London, Ontario, Canada, N6A 5W9
Children's Hospital of Eastern Ontario Completed
Ottawa, Ontario, Canada, K1H 8L1
The Hospital for Sick Children Completed
Toronto, Ontario, Canada, M5G 1X8
Canada, Quebec
CHU Sainte Justine Completed
Montreal, Quebec, Canada, H3T 1C5
Canada
Centre Hospitalier de I'Universite Laval Not yet recruiting
Quebec, Canada, G1V 4G2
France
Hôpital Necker-enfants Completed
Paris, Malades Paris, France, 75015
Place Amélie Raba Léon Not yet recruiting
Bordeaux, France, 33076
Contact: Olivier Brissaud, MD    +33 (0)5 56 79 56 43    olivier.brissaud@chu-bordeaux.fr   
Contact: Hélène PETIT, MD    +33 (0)2 99 54 42 22    helene.petit@efs.sante.fr   
Principal Investigator: Olivier Brissaud, MD         
Sub-Investigator: Hélène PETIT, MD         
Hôpital Jeanne de Flandre Recruiting
Lille, France, 59037
Contact: Stéphane Leteurtre, MD    +33 (0)3 20 44 68 79    stephane.leteurtre@chru-lille.fr   
Contact: Eric RESCH, MD    +33 (0)3 28 54 20 30    eric.resch@efs.sante.fr   
Principal Investigator: Stéphane Leteurtre, MD         
Sub-Investigator: Eric RESCH, MD         
Hôpital Mère Enfant Not yet recruiting
Nantes, France, 44093
Contact: Nicolas Joram, MD    33 (0)2 40 08 34 83    Nicolas.JORAM@chu-nantes.fr   
Contact: Catherine DAVID, MD    +33 (0)2 41 72 44 41    catherine.david@efs.sante.fr   
Principal Investigator: Nicolas Joram, MD         
Sub-Investigator: Catherine DAVID, MD         
Hôpital Robert Debré Completed
Paris, France, 75019
Hôpital Universitaire Necker - Enfants Malades Not yet recruiting
Paris, France, 75743
Contact: Gilles Orliaguet, MD    +33 (0)1 44 49 40 00    gilles.orliaguet@nck.aphp.fr   
Contact: Anne Francois, MD    +33 (0) 1 53 78 21 60    anne.francois@efs.sante.fr   
Principal Investigator: Gilles Orliaguet, MD         
Sub-Investigator: Anne Francois, MD         
CHU Pontchaillou Not yet recruiting
Rennes, France, 35033
Contact: Théophile Gaillot, MD    +33 (0)2 99 26 58 85    theophile.gaillot@chu-rennes.fr   
Contact: Julie VASSE, MD    +33 (0)2 99 54 42 22    julie.vasse@efs.sante.fr   
Principal Investigator: Théophile Gaillot, MD         
Sub-Investigator: Julie VASSE, MD         
Israel
Sheba Medical Center Completed
Tel HaShomer, Israel
Italy
Policlinico Catania Hospital Withdrawn
Catania, Italy
Meyer's Hospital Completed
Florence, Italy
Bamino Gesú Completed
Rome, Italy, 00165
Sponsors and Collaborators
Washington University School of Medicine
National Heart, Lung, and Blood Institute (NHLBI)
Canadian Institutes of Health Research (CIHR)
Ministere de la Sante et des Services Sociaux
Investigators
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Principal Investigator: Philip C. Spinella, MD Washington University School of Medicine, St. Louis
Principal Investigator: Marisa Tucci, MD Ste-Justine Hospital, Montreal

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01977547     History of Changes
Other Study ID Numbers: 201302030
1U01HL116383-01 ( U.S. NIH Grant/Contract )
MOP 126113 ( Other Grant/Funding Number: Canadian Institutes of Health Research (CIHR) )
First Posted: November 6, 2013    Key Record Dates
Last Update Posted: October 2, 2018
Last Verified: October 2018

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