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| ID | Type | Description | Link |
|---|---|---|---|
| R01HL098014 | 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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Packed red blood cell units destined for transfusion can be stored for up to 42 days prior to transfusion based on Food and Drug Administration (FDA) guidelines. Recent studies suggest that certain patients transfused with blood stored for longer duration have poorer outcomes than patients transfused fresher blood. The investigators' hypothesis is that the delivery of an immediate and substantial load of hemoglobin-associated iron from a stored unit of blood leads to changes that explain the differences in outcome between patients transfused old versus fresh blood. The investigators propose to test this hypothesis in humans by transfusing an individual's own blood, both fresh and after storage, and comparing levels of various outcome measures.
Participants in this study will be asked to participate in a standard blood donation. The blood will be processed per standards at the investigators regional blood center (New York Blood Center) and then split into two equal units and shipped to Columbia University Medical Center for storage and transfusion. One unit will be transfused back into the same individual fresh (i.e. between 3-7 days after donation). The other unit will be transfused 42 days after donation. Blood samples will be drawn before, during, and after transfusion to measure levels of various analytes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fresh transfusion | Other | 1 unit autologous transfusion of red blood cells stored for 3-7 days under standard conditions |
|
| Old transfusion | Experimental | 1 unit autologous transfusion of red blood cells stored for 40-42 days under standard conditions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fresh transfusion | Procedure | 1 unit autologous transfusion of red blood cells stored for 3-7 days under standard conditions |
|
| Measure | Description | Time Frame |
|---|---|---|
| Measure of Non-transferrin-bound Iron | Comparison of increase in non-transferrin-bound iron for each participant between his or her "fresh" and "old" blood transfusion four hours after transfusion. | four hours after transfusion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Spitalnik 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 |
|---|---|---|---|
| 22021369 | Result | Hod EA, Brittenham GM, Billote GB, Francis RO, Ginzburg YZ, Hendrickson JE, Jhang J, Schwartz J, Sharma S, Sheth S, Sireci AN, Stephens HL, Stotler BA, Wojczyk BS, Zimring JC, Spitalnik SL. Transfusion of human volunteers with older, stored red blood cells produces extravascular hemolysis and circulating non-transferrin-bound iron. Blood. 2011 Dec 15;118(25):6675-82. doi: 10.1182/blood-2011-08-371849. Epub 2011 Oct 20. |
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The recruitment of volunteers began in December 2008 and ended in October 2010. All the volunteers were recruited at Columbia University.
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| ID | Title | Description |
|---|---|---|
| FG000 | Transfusion | Fresh transfusion : 1 unit autologous transfusion of red blood cells stored for 3-7 days under standard conditions followed by old transfusion : 1 unit autologous transfusion of red blood cells stored for 40-42 days under standard conditions |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Transfusion | Fresh transfusion: 1 unit autologous transfusion of red blood cells stored for 40-42 days under standard conditions 1 unit autologous transfusion of red blood cells stored for 3-7 days under standard conditions Old transfusion: 1 unit autologous transfusion of red blood cells stored for 40-42 days under standard conditions |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Measure of Non-transferrin-bound Iron | Comparison of increase in non-transferrin-bound iron for each participant between his or her "fresh" and "old" blood transfusion four hours after transfusion. | Posted | Mean | Standard Deviation | μM | four hours after 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 | Fresh transfusion : 1 unit autologous transfusion of red blood cells stored for 3-7 days under standard conditions followed by old transfusion : 1 unit autologous transfusion of red blood cells stored for 40-42 days under standard conditions |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment | Vasovagal at time of donation |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Steven Spitalnik | Columbia University | 2123425648 | eldad.hod@gmail.com |
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| ID | Term |
|---|---|
| D000755 | Anemia, Sickle Cell |
| ID | Term |
|---|---|
| D000745 | Anemia, Hemolytic, Congenital |
| D000743 | Anemia, Hemolytic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
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|
| Old transfusion | Procedure | 1 unit autologous transfusion of red blood cells stored for 40-42 days under standard conditions |
|
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| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units | Counts |
|---|---|
| Participants |
|
|
| 0 |
| 14 |
| 3 |
| 14 |
|
| Headache | Nervous system disorders | Non-systematic Assessment |
|
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| D006425 |
| Hemic and Lymphatic Diseases |
| D006453 | Hemoglobinopathies |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |