Clinical trial NCT02087553: PICU Transfusion Study: Harmful Effects of Red Blood Cell Transfusions
Official title: Harmful Effects of Red Blood Cell Transfusions Are Mediated by Iron: Pediatric ICU Aim
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Iron, Abnormal Blood Level
Keywords: Blood Transfusion
Iron
Packed Red Blood Cells
PRBC
NTBI
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2014-03-14
Enrollment: 120
Sex: ALL
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hospitalized pediatric patients admitted to the Columbia University Medical Center's Pediatric ICU

Brief summary: The investigators hypothesize that the storage-damaged red cells are responsible for some of the adverse effects of transfusion. In this observational study, the investigators will measure various laboratory parameters both before and after transfusion in a pediatric intensive care unit to determine at what duration of storage is there laboratory evidence of refrigerator storage damage.

The investigators hypothesize that increasing storage time of packed red blood cells (PRBCs) transfused will be associated with increasing non-transferrin-bound iron (NTBI), pro-inﬂammatory cytokine concentrations, and enhanced microbial growth in vitro in pediatric patients.

Detailed description: Transfusions of red blood cells (RBCs) stored for longer durations are associated with adverse effects in hospitalized patients. During storage, RBCs undergo cumulative changes that reduce their survival in vivo, and have been associated with impairment in oxygen transport and adverse outcomes. Transfusion of older RBCs results in increased NTBI levels in healthy adults, and elevated NTBI levels have been associated with increased morbidity and mortality in hospitalized patients. Transfusion of PRBCs has also been associated with up-regulation of inﬂammatory cytokines. Pediatric patients are exposed to PRBC transfusions; however, this patient population has not been previously studied for these outcomes.

According to current practice guidelines, PRBCs are stored in the blood bank up to 42 days prior to transfusion. In this study, blood sample will be collected from pediatric ICU patients prior to every PRBC transfusion and again 2-6 hours post-transfusion to determine iron parameters, inﬂammatory marker concentrations, and growth of microbial pathogens in vitro.

The investigators hopes to further the understanding of the effects of blood storage on outcome in children, thereby making transfusion safer and more effective.

Eligibility criteria: Inclusion Criteria:

* Less than 21 years of age;
* Greater than 5kg weight;
* Parents or legal guardian have signed informed consent;
* Will be receiving transfusion of packed, leukoreduced RBCs stored in an additive saline (AS) solution (standard practice).

Exclusion Criteria:

* Patients have undergone transfusion of platelets or fresh frozen plasma 4 hours before or will receive these products after transfusion of the RBC unit;
* Transfusion of RBC from more than one donor at the test transfusion event.

Primary outcomes:
measure: Non-transferrin-bound iron level
timeFrame: Up to 12-hours post-transfusion
Secondary outcomes:
measure: Hepcidin level
timeFrame: Up to 12-hours post-transfusion
measure: Level of C-Reactive Protein (CRP)
timeFrame: Up to 12 hours post-transfusion
measure: Level of Monocyte Chemoattractant Protein (MCP)-1
timeFrame: Up to 12 hours post-transfusion
measure: Level of Interleukin (IL)-6
timeFrame: Up to 12 hours post-transfusion
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
Study officials:
affiliation: Columbia University
name: Eldad A Hod, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: L'Acqua C, Bandyopadhyay S, Francis RO, McMahon DJ, Nellis M, Sheth S, Kernie SG, Brittenham GM, Spitalnik SL, Hod EA. Red blood cell transfusion is associated with increased hemolysis and an acute phase response in a subset of critically ill children. Am J Hematol. 2015 Oct;90(10):915-20. doi: 10.1002/ajh.24119.