PICU Transfusion Study: Harmful Effects of Red Blood Cell Transfusions

Completed

• Conditions: Iron, Abnormal Blood Level
• Interventions: Biological: Transfusion of red blood cells; Biological: Infusion of albumin/saline

• Registration Number: NCT02087553
• Lead Sponsor: Columbia University

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.

Study Timeline

• Study Start: 2013-12
• Study First Submitted: 2014-03-12
• Study First Submitted QC: 2014-03-12
• Study First Posted: 2014-03-14
• Primary Completion: 2014-10
• Study Completion: 2018-12
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-25
• Last Update Posted: 2019-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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).

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Transfused pediatric patients	Transfusion of red blood cells	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	Infusion of albumin/saline	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.

Primary Outcome Measures

Name	Time	Method
Non-transferrin-bound iron level	Up to 12-hours post-transfusion	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.

Secondary Outcome Measures

Name	Time	Method
Level of Monocyte Chemoattractant Protein (MCP)-1	Up to 12 hours post-transfusion
Level of C-Reactive Protein (CRP)	Up to 12 hours post-transfusion
Hepcidin level	Up to 12-hours post-transfusion
Level of Interleukin (IL)-6	Up to 12 hours post-transfusion

Trial Locations

Locations (2)

Weill Cornell Medical College; 🇺🇸 New York, New York, United States

Columbia University Medical Center; 🇺🇸 New York, New York, United States