An observational study in Iron, Abnormal Blood Level, sponsored by Columbia University. Completed at 2 sites in United States. Open to participants aged Up to 21 Years. Per ClinicalTrials.gov, last updated 2019-03-27.
Sponsored by Columbia University · Observational
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.
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.
Columbia University is the lead sponsor of 1,103 studies on the registry; 193 are open to participants now.
Of its 172 completed or terminated interventional studies of FDA-regulated products, 142 (83%) have results posted.
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Hospitalized pediatric patients admitted to the Columbia University Medical Center's Pediatric ICU
Exclusion Criteria:
Children who might receive packed red blood cell (PRBC) transfusion will be enrolled after obtaining consent from their parents/legal guardians and assent from the patient, if possible. Transfusion of red blood cells will be done according to standard of care.
Biological: Transfusion of red blood cells
Children who might receive albumin or saline for volume resuscitation will be enrolled after obtaining consent from their parents/legal guardians and assent from the patient, if possible. Infusion will be done according to standard of care.
Biological: Infusion of albumin/saline
(non-experimental) PRBC transfusion
Also known as: Packed Red Blood Cells (PRBCs)
(non-experimental) albumin/saline infusion
Also known as: Albumin/Saline
Non-transferrin-bound iron level
Circulating non-transferrin-bound iron level post-transfusion (taken between 2-6 hours post-transfusion and 8-12 hours post-transfusion) vs the pre-transfusion level.
Time frame: Up to 12-hours post-transfusion
Hepcidin level
Time frame: Up to 12-hours post-transfusion
Level of C-Reactive Protein (CRP)
Time frame: Up to 12 hours post-transfusion
Level of Monocyte Chemoattractant Protein (MCP)-1
Time frame: Up to 12 hours post-transfusion
Level of Interleukin (IL)-6
Time frame: Up to 12 hours post-transfusion
Plan to share: Undecided
This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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