PICU Transfusion Study: Harmful Effects of Red Blood Cell Transfusions
Completed
Conditions studied: Iron, Abnormal Blood Level
In brief
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.
Key facts
- Study ID
- NCT02087553
- Run by
- Columbia University
- People needed
- 120
- Starts
- 2013-12-01
- Expected to finish
- 2018-12-01
- Last updated by the study team
- 2019-03-27
Who can join
Age: any, up to 21. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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).
You may not qualify if…
- 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.
Where it is running
- Columbia University Medical Center — New York, New York, United States
- Weill Cornell Medical College — New York, New York, United States
Full record on ClinicalTrials.gov
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