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Completed

NCT Number: NCT02087553

PICU Transfusion Study: Harmful Effects of Red Blood Cell Transfusions

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.

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Key information

Age range

Up to 21 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Columbia University Medical Center, New York, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Transfusion of red blood cells

Biological

(non-experimental) PRBC transfusion

Other names: Packed Red Blood Cells (PRBCs)

Infusion of albumin/saline

Biological

(non-experimental) albumin/saline infusion

Other names: Albumin/Saline

Primary outcomes

  1. Non-transferrin-bound iron level

    Time frame: 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 outcomes

  1. Hepcidin level

    Time frame: Up to 12-hours post-transfusion

  2. Level of C-Reactive Protein (CRP)

    Time frame: Up to 12 hours post-transfusion

  3. Level of Monocyte Chemoattractant Protein (MCP)-1

    Time frame: Up to 12 hours post-transfusion

  4. Level of Interleukin (IL)-6

    Time frame: Up to 12 hours post-transfusion

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

Harmful Effects of Red Blood Cell Transfusions Are Mediated by Iron: Pediatric ICU Aim

Important dates

Study start
2013
Primary completion
2014
Study completion
2018
First posted
Mar 14, 2014
Registry last updated
Mar 27, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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