Duration of Red Blood Cell Storage Prior to Transfusion

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Duration of Red Blood Cell Storage Prior to Transfusion and Non-Transferrin-Bound Iron

Conditions
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Iron, Blood Level Abnormal

Intervention / Treatment
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* Procedure: Blood Transfusion
* Other: Packed red blood cells


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-65 years old Body weight >110 lbs Hemoglobin >12.5 g/dL Exclusion Criteria: Ineligible for donation based on the New York Blood Center blood donor questionnaire Systolic blood pressure >180 or <90 mm Hg, diastolic blood pressure >100 or <50 mm Hg Heart rate <50 or >100 Temperature >99.5 F prior to donation Temperature >100.4 F or subjective feeling of illness prior to transfusion (this is to avoid having a concurrent illness affect post-transfusion measurements); Positive results on standard blood donor infectious disease testing Positive urine pregnancy test

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Transfusion of PRBC stored for 1 week<br>Subjects will receive blood transfusion with packed red blood cells stored for 1 week. | Procedure: Blood Transfusion<br>* A routine medical procedure in which blood is given through an intravenous (IV) line a blood vessel.<br>* Other names: Red blood cell (RBC) transfusion;Other: Packed red blood cells<br>* 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: 1 week 2 weeks 3 weeks 4 weeks 5 weeks 6 weeks<br>* Other names: PRBC;|
| Experimental: Transfusion of PRBC stored for 2 weeks<br>Subjects will receive blood transfusion with packed red blood cells stored for 2 weeks. | Procedure: Blood Transfusion<br>* A routine medical procedure in which blood is given through an intravenous (IV) line a blood vessel.<br>* Other names: Red blood cell (RBC) transfusion;Other: Packed red blood cells<br>* 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: 1 week 2 weeks 3 weeks 4 weeks 5 weeks 6 weeks<br>* Other names: PRBC;|
| Experimental: Transfusion of PRBC stored for 3 weeks<br>Subjects will receive blood transfusion with packed red blood cells stored for 3 weeks. | Procedure: Blood Transfusion<br>* A routine medical procedure in which blood is given through an intravenous (IV) line a blood vessel.<br>* Other names: Red blood cell (RBC) transfusion;Other: Packed red blood cells<br>* 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: 1 week 2 weeks 3 weeks 4 weeks 5 weeks 6 weeks<br>* Other names: PRBC;|
| Experimental: Transfusion of PRBC stored for 4 weeks<br>Subjects will receive blood transfusion with packed red blood cells stored for 4 weeks. | Procedure: Blood Transfusion<br>* A routine medical procedure in which blood is given through an intravenous (IV) line a blood vessel.<br>* Other names: Red blood cell (RBC) transfusion;Other: Packed red blood cells<br>* 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: 1 week 2 weeks 3 weeks 4 weeks 5 weeks 6 weeks<br>* Other names: PRBC;|
| Experimental: Transfusion of PRBC stored for 5 weeks<br>Subjects will receive blood transfusion with packed red blood cells stored for 5 weeks. | Procedure: Blood Transfusion<br>* A routine medical procedure in which blood is given through an intravenous (IV) line a blood vessel.<br>* Other names: Red blood cell (RBC) transfusion;Other: Packed red blood cells<br>* 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: 1 week 2 weeks 3 weeks 4 weeks 5 weeks 6 weeks<br>* Other names: PRBC;|
| Experimental: Transfusion of PRBC stored for 6 weeks<br>Subjects will receive blood transfusion with packed red blood cells stored for 6 weeks. | Procedure: Blood Transfusion<br>* A routine medical procedure in which blood is given through an intravenous (IV) line a blood vessel.<br>* Other names: Red blood cell (RBC) transfusion;Other: Packed red blood cells<br>* 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: 1 week 2 weeks 3 weeks 4 weeks 5 weeks 6 weeks<br>* Other names: PRBC;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Non-transferrin-bound Iron Level (AUC) | 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). | 0, 2, 4, 6, 8, 10, 12, 14 and 24 after transfusion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Iron, Red Blood Cells, Blood Transfusion