Columbia University Medical Center
New York, 10032, United States
NCT Number: NCT02087514
This study will determine the minimal duration of red blood cell (RBC) storage that leads to increases in circulating non-transferrin-bound iron in healthy human volunteers post-transfusion. The results from this study will help guide national guidelines for appropriate duration of RBC storage prior to transfusion, which is currently 6 weeks by Food and Drug Administration (FDA) criteria. The overall objective of this research is to improve the safety of refrigerated storage of red blood cells before transfusion.
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Notify Me18 year–65 year
All sexes
Interventional
Not applicable
New York, 10032, United States
Recent studies suggest that older stored blood is associated with worse outcomes in certain hospitalized patients. Red cells may be stored in a refrigerator prior to transfusion for up to 42 days by current FDA standards. Refrigerator storage of red cells is associated with a storage lesion and the survival of transfused red cells decreases with increasing storage time, thus older blood is associated with an increased delivery of hemoglobin-iron to certain parts of the body. The investigators have preliminary data in mice and humans suggesting that delivery of a significant iron load from aged red cells leads to the production of a potentially toxic form of circulating iron called non-transferrin-bound iron.
In this prospective study of healthy volunteers, each subject will be randomized to receive transfusion of one RBC unit after 1, 2, 3, 4, 5, or 6 weeks of storage. The primary outcome will be the 24 hr area under the curve (AUC) of the serum non-transferrin bound iron concentration calculated from samples collected at 0, 2, 4, 6, 8, 10, 12, 14 and 24 hours after transfusion.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A routine medical procedure in which blood is given through an intravenous (IV) line a blood vessel.
Other names: Red blood cell (RBC) transfusion
Red blood cells that have been collected, processed, and stored in bags as blood product units available for blood transfusion.
A standard autologous leukoreduced packed red blood cell unit will be collected and stored in AS-3 solution in the Columbia University Medical Center blood bank.
The number of weeks in storage are as follows:
Other names: PRBC
Time frame: 0, 2, 4, 6, 8, 10, 12, 14 and 24 after transfusion
Area under the curve of change of Non-transferrin-bound iron from immediately after transfusion to end of observation (i.e., from 0-hr after transfusion to 24-hr after transfusion).
Columbia University
Other
Duration of Red Blood Cell Storage Prior to Transfusion and Non-Transferrin-Bound Iron
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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.