Short storage RBC age
BiologicalIND obtained to cover the expiration date on the red blood cell unit
NCT Number: NCT01977547
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).
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Notify Me3 day–15 year
All sexes
Interventional
Phase 3
Stollery Children's Hospital, Edmonton, Alberta, Canada
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Patients are considered eligible to participate in the trial if one of the following occur:
OR
OR
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
IND obtained to cover the expiration date on the red blood cell unit
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.
Time frame: Up to 28 days after randomization.
Difference in number of organ dysfunctions.
Time frame: 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.
Time frame: Up to 28 days after randomization.
Difference in nosocomial infection rate.
Time frame: Up to 28 days after randomization.
Difference in the rate of sepsis, severe sepsis or septic shock.
Time frame: Up to 28 days after randomization.
Difference in the rate of acute respiratory distress syndrome.
Time frame: Up to 28 days after randomization.
28 day mechanical ventilation free days
Time frame: Up to 28 days after randomization
Difference in ICU free days.
Time frame: Up to 90 days after randomization
Difference in 90 day mortality.
Time frame: up to 72 hours post last study transfusion
Transfusion Associated Delirium in pediatric critically ill children
Washington University School of Medicine
Other
Acronym: ABC-PICU
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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