Age of Blood in Children in Pediatric Intensive Care Units
Location(s): United States
RBC transfusions are common in critically ill children. Current licensing of RBC storage solutions does not require direct evidence of efficacy in improving oxygen use or non-infectious safety. Mounting data suggests that in critically ill patients the use of older RBCs increases the risk of death or organ failure. This study will definitively determine if the use of fresher RBCs cn improve outcomes in critically ill children.
Specific Aim 1 : Determine whether transfusion of RBC units 7 days compared to standard issue (mean 17- 21 days) RBC units decreases the risk of NPMODS in critically ill children. The primary outcome measure NPMODS is defined as the proportion of patients who develop NPMODS or die during the 28 days after randomization.
Specific Aim 2 : Secondary outcomes will include morbidity and measures to include;transfusion reactions, adverse thrombotic events, nosocomial infections, mechanical ventilation and ICU free days, and mortality at multiple time intervals. If this adequately powered trial does not indicate RBC storage age effects outcomes, the results would reassure clinicians and blood bankers regarding the efficacy and safety of RBC transfusions in critically ill children. If results indicate that RBCs 7 days improve outcomes this will: 1) indicate that prolonged storage has clinical consequences and may influence the modification of regulatory policies on RBC storage;2) potentially influence policies regarding the storage age of RBCs allocated to critically ill children and;3) spark investment in research of RBC storage and rejuvenation solutions to mitigate any potential adverse effects of storage. Positive results would also encourage research directed at understanding the mechanisms underlying the improved outcomes in children transfused RBCs of decreased storage age.