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| ID | Type | Description | Link |
|---|---|---|---|
| R01HL115557 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transfusion of PRBC stored for 1 week | Active Comparator | Subjects will receive blood transfusion with packed red blood cells stored for 1 week. |
|
| Transfusion of PRBC stored for 2 weeks | Experimental | Subjects will receive blood transfusion with packed red blood cells stored for 2 weeks. |
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| Transfusion of PRBC stored for 3 weeks | Experimental | Subjects will receive blood transfusion with packed red blood cells stored for 3 weeks. |
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| Transfusion of PRBC stored for 4 weeks | Experimental | Subjects will receive blood transfusion with packed red blood cells stored for 4 weeks. |
|
| Transfusion of PRBC stored for 5 weeks | Experimental | Subjects will receive blood transfusion with packed red blood cells stored for 5 weeks. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood Transfusion | Procedure | A routine medical procedure in which blood is given through an intravenous (IV) line a blood vessel. |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steven L Spitalnik, MD | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University Medical Center | New York | New York | 10032 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27941245 | Derived | Rapido F, Brittenham GM, Bandyopadhyay S, La Carpia F, L'Acqua C, McMahon DJ, Rebbaa A, Wojczyk BS, Netterwald J, Wang H, Schwartz J, Eisenberger A, Soffing M, Yeh R, Divgi C, Ginzburg YZ, Shaz BH, Sheth S, Francis RO, Spitalnik SL, Hod EA. Prolonged red cell storage before transfusion increases extravascular hemolysis. J Clin Invest. 2017 Jan 3;127(1):375-382. doi: 10.1172/JCI90837. Epub 2016 Dec 12. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Transfusion of PRBC Stored for 1 Week | Subjects will receive blood transfusion with packed red blood cells stored for 1 week. Blood Transfusion: A routine medical procedure in which blood is given through an intravenous (IV) line a blood vessel. Packed red blood cells: 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:
|
| FG001 | Transfusion of PRBC Stored for 2 Weeks | Subjects will receive blood transfusion with packed red blood cells stored for 2 weeks. Blood Transfusion: A routine medical procedure in which blood is given through an intravenous (IV) line a blood vessel. Packed red blood cells: 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:
|
| FG002 | Transfusion of PRBC Stored for 3 Weeks | Subjects will receive blood transfusion with packed red blood cells stored for 3 weeks. Blood Transfusion: A routine medical procedure in which blood is given through an intravenous (IV) line a blood vessel. Packed red blood cells: 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:
|
| FG003 | Transfusion of PRBC Stored for 4 Weeks | Subjects will receive blood transfusion with packed red blood cells stored for 4 weeks. Blood Transfusion: A routine medical procedure in which blood is given through an intravenous (IV) line a blood vessel. Packed red blood cells: 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:
|
| FG004 | Transfusion of PRBC Stored for 5 Weeks | Subjects will receive blood transfusion with packed red blood cells stored for 5 weeks. Blood Transfusion: A routine medical procedure in which blood is given through an intravenous (IV) line a blood vessel. Packed red blood cells: 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:
|
| FG005 | Transfusion of PRBC Stored for 6 Weeks | Subjects will receive blood transfusion with packed red blood cells stored for 6 weeks. Blood Transfusion: A routine medical procedure in which blood is given through an intravenous (IV) line a blood vessel. Packed red blood cells: 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:
|
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
52 out of the 60 enrolled subjects completed the study and were included in data analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | Transfusion of PRBC Stored for 1 Week | Subjects will receive blood transfusion with packed red blood cells stored for 1 week. Blood Transfusion: A routine medical procedure in which blood is given through an intravenous (IV) line a blood vessel. Packed red blood cells: 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:
|
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | 52 out of the 60 enrolled subjects completed the study and were included in data analysis. | Posted | Median | Inter-Quartile Range | microMole*hr/L | 0, 2, 4, 6, 8, 10, 12, 14 and 24 after transfusion |
|
Up to 24 hours post-transfusion.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Transfusion of PRBC Stored for 1 Week | Subjects will receive blood transfusion with packed red blood cells stored for 1 week. Blood Transfusion: A routine medical procedure in which blood is given through an intravenous (IV) line a blood vessel. Packed red blood cells: 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:
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Eldad Hod | Columbia University Medical Center | (212) 342-5648 | eh2217@cumc.columbia.edu |
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| ID | Term |
|---|---|
| D001803 | Blood Transfusion |
| D004906 | Erythrocyte Count |
| ID | Term |
|---|---|
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D001772 | Blood Cell Count |
| D002452 | Cell Count |
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| Transfusion of PRBC stored for 6 weeks | Experimental | Subjects will receive blood transfusion with packed red blood cells stored for 6 weeks. |
|
|
| Packed red blood cells | Other | 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:
|
|
|
| BG001 | Transfusion of PRBC Stored for 2 Weeks | Subjects will receive blood transfusion with packed red blood cells stored for 2 weeks. Blood Transfusion: A routine medical procedure in which blood is given through an intravenous (IV) line a blood vessel. Packed red blood cells: 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:
|
| BG002 | Transfusion of PRBC Stored for 3 Weeks | Subjects will receive blood transfusion with packed red blood cells stored for 3 weeks. Blood Transfusion: A routine medical procedure in which blood is given through an intravenous (IV) line a blood vessel. Packed red blood cells: 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:
|
| BG003 | Transfusion of PRBC Stored for 4 Weeks | Subjects will receive blood transfusion with packed red blood cells stored for 4 weeks. Blood Transfusion: A routine medical procedure in which blood is given through an intravenous (IV) line a blood vessel. Packed red blood cells: 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:
|
| BG004 | Transfusion of PRBC Stored for 5 Weeks | Subjects will receive blood transfusion with packed red blood cells stored for 5 weeks. Blood Transfusion: A routine medical procedure in which blood is given through an intravenous (IV) line a blood vessel. Packed red blood cells: 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:
|
| BG005 | Transfusion of PRBC Stored for 6 Weeks | Subjects will receive blood transfusion with packed red blood cells stored for 6 weeks. Blood Transfusion: A routine medical procedure in which blood is given through an intravenous (IV) line a blood vessel. Packed red blood cells: 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:
|
| BG006 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Transfusion of PRBC Stored for 2 Weeks | Subjects will receive blood transfusion with packed red blood cells stored for 2 weeks. Blood Transfusion: A routine medical procedure in which blood is given through an intravenous (IV) line a blood vessel. Packed red blood cells: 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:
|
| OG002 | Transfusion of PRBC Stored for 3 Weeks | Subjects will receive blood transfusion with packed red blood cells stored for 3 weeks. Blood Transfusion: A routine medical procedure in which blood is given through an intravenous (IV) line a blood vessel. Packed red blood cells: 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:
|
| OG003 | Transfusion of PRBC Stored for 4 Weeks | Subjects will receive blood transfusion with packed red blood cells stored for 4 weeks. Blood Transfusion: A routine medical procedure in which blood is given through an intravenous (IV) line a blood vessel. Packed red blood cells: 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:
|
| OG004 | Transfusion of PRBC Stored for 5 Weeks | Subjects will receive blood transfusion with packed red blood cells stored for 5 weeks. Blood Transfusion: A routine medical procedure in which blood is given through an intravenous (IV) line a blood vessel. Packed red blood cells: 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:
|
| OG005 | Transfusion of PRBC Stored for 6 Weeks | Subjects will receive blood transfusion with packed red blood cells stored for 6 weeks. Blood Transfusion: A routine medical procedure in which blood is given through an intravenous (IV) line a blood vessel. Packed red blood cells: 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:
|
|
|
| 0 |
| 8 |
| 0 |
| 8 |
| 0 |
| 8 |
| EG001 | Transfusion of PRBC Stored for 2 Weeks | Subjects will receive blood transfusion with packed red blood cells stored for 2 weeks. Blood Transfusion: A routine medical procedure in which blood is given through an intravenous (IV) line a blood vessel. Packed red blood cells: 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:
| 0 | 10 | 0 | 10 | 0 | 10 |
| EG002 | Transfusion of PRBC Stored for 3 Weeks | Subjects will receive blood transfusion with packed red blood cells stored for 3 weeks. Blood Transfusion: A routine medical procedure in which blood is given through an intravenous (IV) line a blood vessel. Packed red blood cells: 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:
| 0 | 7 | 0 | 7 | 0 | 7 |
| EG003 | Transfusion of PRBC Stored for 4 Weeks | Subjects will receive blood transfusion with packed red blood cells stored for 4 weeks. Blood Transfusion: A routine medical procedure in which blood is given through an intravenous (IV) line a blood vessel. Packed red blood cells: 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:
| 0 | 8 | 0 | 8 | 0 | 8 |
| EG004 | Transfusion of PRBC Stored for 5 Weeks | Subjects will receive blood transfusion with packed red blood cells stored for 5 weeks. Blood Transfusion: A routine medical procedure in which blood is given through an intravenous (IV) line a blood vessel. Packed red blood cells: 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:
| 0 | 10 | 0 | 10 | 0 | 10 |
| EG005 | Transfusion of PRBC Stored for 6 Weeks | Subjects will receive blood transfusion with packed red blood cells stored for 6 weeks. Blood Transfusion: A routine medical procedure in which blood is given through an intravenous (IV) line a blood vessel. Packed red blood cells: 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:
| 0 | 9 | 0 | 9 | 0 | 9 |
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| D003584 |
| Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D006403 | Hematologic Tests |
| D008919 | Investigative Techniques |
| D002468 | Cell Physiological Phenomena |
| D001790 | Blood Physiological Phenomena |
| D002943 | Circulatory and Respiratory Physiological Phenomena |