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| ID | Type | Description | Link |
|---|---|---|---|
| R01HL115557 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transfused pediatric patients | 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. |
| |
| Saline/Albumin infusion | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transfusion of red blood cells | Biological | (non-experimental) PRBC transfusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 12-hours post-transfusion |
| Measure | Description | Time Frame |
|---|---|---|
| Hepcidin level | Up to 12-hours post-transfusion | |
| Level of C-Reactive Protein (CRP) | Up to 12 hours post-transfusion | |
| Level of Monocyte Chemoattractant Protein (MCP)-1 |
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Inclusion Criteria:
Exclusion Criteria:
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Hospitalized pediatric patients admitted to the Columbia University Medical Center's Pediatric ICU
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| Name | Affiliation | Role |
|---|---|---|
| Eldad A Hod, MD | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University Medical Center | New York | New York | 10032 | United States | ||
| Weill Cornell Medical College |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26183122 | Result | 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. |
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| ID | Term |
|---|---|
| D017707 | Erythrocyte Transfusion |
| D012965 | Sodium Chloride |
| D000418 | Albumins |
| ID | Term |
|---|---|
| D016913 | Blood Component Transfusion |
| D001803 | Blood Transfusion |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
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Serum and plasma samples both pre- and post-transfusion samples of the transfusate
| Infusion of albumin/saline | Biological | (non-experimental) albumin/saline infusion |
|
|
| Up to 12 hours post-transfusion |
| Level of Interleukin (IL)-6 | Up to 12 hours post-transfusion |
| New York |
| New York |
| 10065 |
| United States |
| D002712 |
| Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |