AnemiaPhase 3ABC-PICUNCT01977547
Age of Blood in Children in Pediatric Intensive Care Units
A Phase 3 study testing Short storage RBC age in people with Anemia, run by Washington University School of Medicine at 37 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 days to 15 years
- Conditions the study is for
- Anemia
- What is being tested?
- Short storage RBC age
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,538 participants
- Where
- 37 sitesin 5 countries
- Study dates
- Jan 2014to Dec 2018
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 days to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Show all 20Show fewer
- 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
Trial locations and contacts
37 sites in 5 countries.
37 sites in 5 countries
United States20 sites
The Children's Hospital and University of Colorado Denver School of Medicine
Aurora, Colorado, 80045
University of Alabama at Birmingham
Birmingham, Alabama, 35223
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Nationwide Children's Hospital
Columbus, Ohio, 43205
Children's Medical Center Dallas
Dallas, Texas, 75390
Duke University
Durham, North Carolina, 27710
UF Health Shands Children's Hospital
Gainesville, Florida
Texas Children's Hospital
Houston, Texas, 77030
James Whitcomb Riley Hospital for Children
Indianapolis, Indiana, 46202
Children's Hospital Los Angeles
Los Angeles, California, 90027
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53226
Weill Cornell Medical College
New York, New York, 10065
Children's Hospital of Orange County
Orange, California, 92868
Lutheran General Hospital
Park Ridge, Illinois
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Golisano Children's Hospital at Strong
Rochester, New York, 14642
University of California, San Francisco
San Francisco, California, 94143
Washington University School of Medicine
St Louis, Missouri, 63110
Diamond Children's Medical Center
Tucson, Arizona, 85721
Canada7 sites
Stollery Children's Hospital
Edmonton, Alberta, T6G 2B7
IWK Health Centre
Halifax, Nova Scotia, B3K 6R8
London Health Sciences Centre
London, Ontario, N6A 5W9
CHU Sainte Justine
Montreal, Quebec, H3T 1C5
Children's Hospital of Eastern Ontario
Ottawa, Ontario, K1H 8L1
Centre Hospitalier de I'Universite Laval
Québec, G1V 4G2
The Hospital for Sick Children
Toronto, Ontario, M5G 1X8
France7 sites
Place Amélie Raba Léon
Bordeaux, 33076
Hôpital Jeanne de Flandre
Lille, 59037
Hôpital Mère Enfant
Nantes, 44093
Hôpital Necker-enfants
Paris, Malades Paris, 75015
Hôpital Robert Debré
Paris, 75019
Hôpital Universitaire Necker - Enfants Malades
Paris, 75743
CHU Pontchaillou
Rennes, 35033
About this study
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).
- Conditions
- Anemia
- Being tested
- Short storage RBC age
- Keywords
- Red blood cell transfusions, Red blood cell storage age, Pediatrics, Critical Care
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Short storage RBC ageBiological
IND obtained to cover the expiration date on the red blood cell unit
| Study group | Role | What they receive |
|---|---|---|
| Short storage | Active comparator | Red blood cells storage duration of equal to or less than 7 days. Receives: Biological: Short storage RBC age |
| Standard issue | Active comparator | Red blood cells storage duration of 2 to 42 days with an expected average length of storage of about 17-21 days. Receives: Biological: Short storage RBC age |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With New or Progressive Multiple Organ Dysfunction Syndrome (NPMODS)
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.
Measured: 28 days after randomization
Secondary outcomes (9)
Organ Dysfunction
Difference in number of organ dysfunctions.
Measured: Up to 28 days after randomization.
PELOD-2 Score
Difference in PELOD-2 score. Change from randomization to Worst PELOD-2 score. (Pediatric Logistic Organ Dysfunction) Points are on a range of 0-6 and based on Neurologic, cardiovascular, renal, respiratory, and hematologic function. The higher the score the worse the organ failure is and higher mortality rate.
Measured: Up to 28 days after randomization.
Nosocomial Infection
Difference in nosocomial infection rate.
Measured: Up to 28 days after randomization.
Sepsis, Severe Sepsis, Septic Shock
Difference in the rate of sepsis, severe sepsis or septic shock.
Measured: Up to 28 days after randomization.
Acute Respiratory Distress Syndrome
Difference in the rate of acute respiratory distress syndrome.
Measured: Up to 28 days after randomization.
Mechanical Ventilation
28 day mechanical ventilation free days
Measured: Up to 28 days after randomization.
ICU Free Days
Difference in ICU free days.
Measured: Up to 28 days after randomization
Mortality
Difference in 90 day mortality.
Measured: Up to 90 days after randomization
Delirium
Transfusion Associated Delirium in pediatric critically ill children
Measured: up to 72 hours post last study transfusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2013 (estimated)
- Study startJan 2014
- Primary completionDec 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AnemiaStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 1,538 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Canadian Institutes of Health Research (CIHR), Ministere de la Sante et des Services Sociaux
- Responsible party
- Sponsor
- Investigators
- Philip C. Spinella, MD, Principal investigator, Washington University School of Medicine, St. LouisMarisa Tucci, MD, Principal investigator, Ste-Justine Hospital, Montreal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01977547
- Sponsor's protocol ID
- 201302030
- Other IDs
- 1U01HL116383-01, MOP 126113
- Acronym
- ABC-PICU
- Status last verified
- Apr 2021
- First submitted
- 9 Aug 2013
- Last updated
- 29 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Spinella PC, Tucci M, Fergusson DA, Lacroix J, Hebert PC, Leteurtre S, Schechtman KB, Doctor A, Berg RA, Bockelmann T, Caro JJ, Chiusolo F, Clayton L, Cholette JM, Guerra GG, Josephson CD, Menon K, Muszynski JA, Nellis ME, Sarpal A, Schafer S, Steiner ME, Turgeon AF; ABC-PICU Investigators, the Canadian Critical Care Trials Group, the Pediatric Acute Lung Injury and Sepsis Investigators Network, the BloodNet Pediatric Critical Care Blood Research Network, and the Groupe Francophone de Reanimation et Urgences P. Effect of Fresh vs Standard-issue Red Blood Cell Transfusions on Multiple Organ Dysfunction Syndrome in Critically Ill Pediatric Patients: A Randomized Clinical Trial. JAMA. 2019 Dec 10;322(22):2179-2190. doi: 10.1001/jama.2019.17478.
PubMed 31821429Tucci M, Lacroix J, Fergusson D, Doctor A, Hebert 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.
PubMed 30055634
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Age of Blood in Children in Pediatric Intensive Care Units
- ClinicalTrials.gov ID
- NCT01977547
- Acronym / sponsor ID
- ABC-PICU / 201302030
- Conditions
- Anemia
- Keywords
- Red blood cell transfusions, Red blood cell storage age, Pediatrics, Critical Care
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,538 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Canadian Institutes of Health Research (CIHR), Ministere de la Sante et des Services Sociaux
- Study start
- Jan 2014
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 6 Nov 2013 (estimated)
- Results
- Posted 29 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Short storage | Active comparator | Biological: Short storage RBC ageRed blood cells storage duration of equal to or less than 7 days. |
| Standard issue | Active comparator | Biological: Short storage RBC ageRed blood cells storage duration of 2 to 42 days with an expected average length of storage of about 17-21 days. |
Who may qualify
- Ages
- 3 days to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Short storage RBC ageIND obtained to cover the expiration date on the red blood cell unit | Biological | Short storage, Standard issue |
Primary outcome
Number of Participants With 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.
9 secondary outcomes
Organ Dysfunction
Time frame: Up to 28 days after randomization.
PELOD-2 Score
Time frame: Up to 28 days after randomization.
Nosocomial Infection
Time frame: Up to 28 days after randomization.
Sepsis, Severe Sepsis, Septic Shock
Time frame: Up to 28 days after randomization.
Acute Respiratory Distress Syndrome
Time frame: Up to 28 days after randomization.
Mechanical Ventilation
Time frame: Up to 28 days after randomization.
ICU Free Days
Time frame: Up to 28 days after randomization
Mortality
Time frame: Up to 90 days after randomization
Delirium
Time frame: up to 72 hours post last study transfusion
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31821429Spinella PC, Tucci M, Fergusson DA, Lacroix J, Hebert PC, Leteurtre S, Schechtman KB, Doctor A, Berg RA, Bockelmann T, Caro JJ, Chiusolo F, Clayton L, Cholette JM, Guerra GG, Josephson CD, Menon K, Muszynski JA, Nellis ME, Sarpal A, Schafer S, Steiner ME, Turgeon AF; ABC-PICU Investigators, the Canadian Critical Care Trials Group, the Pediatric Acute Lung Injury and Sepsis Investigators Network, the BloodNet Pediatric Critical Care Blood Research Network, and the Groupe Francophone de Reanimation et Urgences P. Effect of Fresh vs Standard-issue Red Blood Cell Transfusions on Multiple Organ Dysfunction Syndrome in Critically Ill Pediatric Patients: A Randomized Clinical Trial. JAMA. 2019 Dec 10;322(22):2179-2190. doi: 10.1001/jama.2019.17478.
- Derived from this study: PubMed 30055634Tucci M, Lacroix J, Fergusson D, Doctor A, Hebert 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philip C. Spinella, MD principal investigator
Washington University School of Medicine, St. Louis
Marisa Tucci, MD principal investigator
Ste-Justine Hospital, Montreal
37 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Short storage RBC age in people with Anemia, run by Washington University School of Medicine at 37 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites in United States, Canada, France, Italy, Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With New or Progressive Multiple Organ Dysfunction Syndrome (NPMODS) (time frame: 28 days after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01977547, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2021.