Age of Blood in Children in Pediatric Intensive Care Units
- Conditions
- Anemia
- Interventions
- Biological: Short storage RBC age
- Registration Number
- NCT01977547
- Lead Sponsor
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1538
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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Short storage Short storage RBC age Red blood cells storage duration of equal to or less than 7 days. Standard issue Short storage RBC age Red blood cells storage duration of 2 to 42 days with an expected average length of storage of about 17-21 days.
- Primary Outcome Measures
Name Time Method Number of Participants With New or Progressive Multiple Organ Dysfunction Syndrome (NPMODS) 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
Name Time Method Delirium up to 72 hours post last study transfusion Transfusion Associated Delirium in pediatric critically ill children
Nosocomial Infection Up to 28 days after randomization. Difference in nosocomial infection rate.
Mechanical Ventilation Up to 28 days after randomization. 28 day mechanical ventilation free days
Mortality Up to 90 days after randomization Difference in 90 day mortality.
Organ Dysfunction Up to 28 days after randomization. Difference in number of organ dysfunctions.
PELOD-2 Score Up to 28 days after randomization. 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.
Acute Respiratory Distress Syndrome Up to 28 days after randomization. Difference in the rate of acute respiratory distress syndrome.
Sepsis, Severe Sepsis, Septic Shock Up to 28 days after randomization. Difference in the rate of sepsis, severe sepsis or septic shock.
ICU Free Days Up to 28 days after randomization Difference in ICU free days.
Trial Locations
- Locations (37)
Children's Hospital of Orange County
🇺🇸Orange, California, United States
London Health Sciences Centre
🇨🇦London, Ontario, Canada
Bamino Gesú
🇮🇹Rome, Italy
Hôpital Jeanne de Flandre
🇫🇷Lille, France
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
Children's Hospital of Eastern Ontario
🇨🇦Ottawa, Ontario, Canada
IWK Health Centre
🇨🇦Halifax, Nova Scotia, Canada
Hôpital Mère Enfant
🇫🇷Nantes, France
Centre Hospitalier de I'Universite Laval
🇨🇦Quebec, Canada
Weill Cornell Medical College
🇺🇸New York, New York, United States
CHU Sainte Justine
🇨🇦Montreal, Quebec, Canada
The Children's Hospital and University of Colorado Denver School of Medicine
🇺🇸Aurora, Colorado, United States
Golisano Children's Hospital at Strong
🇺🇸Rochester, New York, United States
Meyer's Hospital
🇮🇹Florence, Italy
Place Amélie Raba Léon
🇫🇷Bordeaux, France
Hôpital Universitaire Necker - Enfants Malades
🇫🇷Paris, France
Sheba Medical Center
🇮🇱Tel HaShomer, Israel
Hôpital Necker-enfants
🇫🇷Paris, Malades Paris, France
CHU Pontchaillou
🇫🇷Rennes, France
Children's Hospital Los Angeles
🇺🇸Los Angeles, California, United States
Ann & Robert H. Lurie Children's Hospital of Chicago
🇺🇸Chicago, Illinois, United States
Cincinnati Children's Hospital Medical Center
🇺🇸Cincinnati, Ohio, United States
Nationwide Children's Hospital
🇺🇸Columbus, Ohio, United States
The Children's Hospital of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Children's Medical Center Dallas
🇺🇸Dallas, Texas, United States
The Hospital for Sick Children
🇨🇦Toronto, Ontario, Canada
Diamond Children's Medical Center
🇺🇸Tucson, Arizona, United States
University of California, San Francisco
🇺🇸San Francisco, California, United States
UF Health Shands Children's Hospital
🇺🇸Gainesville, Florida, United States
Lutheran General Hospital
🇺🇸Park Ridge, Illinois, United States
James Whitcomb Riley Hospital for Children
🇺🇸Indianapolis, Indiana, United States
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Hôpital Robert Debré
🇫🇷Paris, France
Duke University
🇺🇸Durham, North Carolina, United States
Texas Children's Hospital
🇺🇸Houston, Texas, United States
Children's Hospital of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
Stollery Children's Hospital
🇨🇦Edmonton, Alberta, Canada