Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 1R01HL133049-01 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| New York Blood Center | OTHER |
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Primary Hypothesis
Iron deficiency is common among regular blood donors, but the recovery and quality of red blood cell (RBC) units from iron-deficient donors has not been rigorously examined. Evidence from both animal and human studies indicate that when the iron supply for erythropoiesis is inadequate, the RBCs produced have multiple metabolic defects that impair their ability to tolerate refrigerated storage. Studies in a mouse model demonstrated decreased post-transfusion recovery of refrigerator-stored RBCs obtained from iron-deficient donors. The planned studies will identify human donors at greatest risk of providing RBCs with poor post-transfusion recovery by using a combination of a decreased serum ferritin concentration and increased RBC zinc protoporphyrin, as described below. To evaluate unequivocally the role of iron deficiency in poor posttransfusion RBC recovery, intravenous iron will be used for iron repletion.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Iron repletion | Active Comparator | Subjects will donate blood donation and undergo 24-hour PTR and receive IV iron-dextran. After 5 months, subjects will donate blood again, receive IV saline and undergo 24-hour PTR. |
|
| Placebo | Placebo Comparator | Subjects will donate blood donation and undergo 24-hour PTR and receive IV saline. After 5 months, subjects will donate blood again, receive IV iron-dextran and undergo 24-hour PTR. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Iron-dextran | Drug | Approved for clinical use: 1-gram dose IV - diluted in 500 mL, one pint normal saline. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 51-Chromium 24-hour Post-transfusion RBC Recovery of Units | Comparison of the percentage change in 51-Chromium-labeled RBCs remaining from pre- and 24 hour post-transfusion measurement between the Iron Repletion and the Placebo group. The post-transfusion recovery represents the percent of 51-Chromium-labeled RBCs remaining in circulation 24 hours after infusion as compared to an extrapolated time zero measurement. | Performed 42 days after blood donation |
| Measure | Description | Time Frame |
|---|---|---|
| RBC Zinc Protoporphyrin Levels | Measured in a clinical laboratory. Will be used to determine the association between pre-donation zinc protoporphyrin levels and post-transfusion recovery along with the effect of treatment on zinc protoporphyrin levels. | End of participation (e.g., ~6 months) |
| Serum Ferritin |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Eldad A. Hod, MD | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University Irving Medical Center | New York | New York | 10032 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 6710582 | Background | Moroff G, Sohmer PR, Button LN. Proposed standardization of methods for determining the 24-hour survival of stored red cells. Transfusion. 1984 Mar-Apr;24(2):109-14. doi: 10.1046/j.1537-2995.1984.24284173339.x. | |
| 36069596 | Derived | Hod EA, Brittenham GM, Bitan ZC, Feit Y, Gaelen JI, La Carpia F, Sandoval LA, Zhou AT, Soffing M, Mintz A, Schwartz J, Eng C, Scotto M, Caccappolo E, Habeck C, Stern Y, McMahon DJ, Kessler DA, Shaz BH, Francis RO, Spitalnik SL. A randomized trial of blood donor iron repletion on red cell quality for transfusion and donor cognition and well-being. Blood. 2022 Dec 22;140(25):2730-2739. doi: 10.1182/blood.2022017288. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Iron Repletion | Subjects will donate blood donation and undergo 24-hour PTR and receive IV iron-dextran. After 5 months, subjects will donate blood again and undergo 24-hour PTR. Iron-dextran: Approved for clinical use: 1-gram dose IV - diluted in 500 mL, one pint normal saline. Saline: Salt water IV - 500 mL, one pint normal saline. Blood Donation: Standard process of collecting and storing blood and blood components (approximately 450 mL, or a pint of blood). Following donation, the blood will be leukoreduced, packed, and stored in AS-3 solution. 24-hour PTR: The way the FDA determines how good blood is for transfusion is called a "radioactive 51-Chromium 24-hour post-transfusion red cell recovery study." The purpose is to measure how many of the transfused red cells are still in circulation (being pumped by the heart through blood vessels) 24 hours after transfusion. In order to measure the percent of red cells that are still in circulation, a small amount of the donated blood will be radioactively labeled. This will be infused in one arm and then blood will be collected from the other arm at different time points to measure how much of the transfused red cells are still in circulation. |
| FG001 | Placebo | Subjects will donate blood donation and undergo 24-hour PTR and receive IV saline. After 5 months, subjects will donate blood again and undergo 24-hour PTR. Iron-dextran: Approved for clinical use: 1-gram dose IV - diluted in 500 mL, one pint normal saline. Saline: Salt water IV - 500 mL, one pint normal saline. Blood Donation: Standard process of collecting and storing blood and blood components (approximately 450 mL, or a pint of blood). Following donation, the blood will be leukoreduced, packed, and stored in AS-3 solution. 24-hour PTR: The way the FDA determines how good blood is for transfusion is called a "radioactive 51-Chromium 24-hour post-transfusion red cell recovery study." The purpose is to measure how many of the transfused red cells are still in circulation (being pumped by the heart through blood vessels) 24 hours after transfusion. In order to measure the percent of red cells that are still in circulation, a small amount of the donated blood will be radioactively labeled. This will be infused in one arm and then blood will be collected from the other arm at different time points to measure how much of the transfused red cells are still in circulation. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Completed Primary Outcome |
|
| |||||||||||||||||||||
| Completed Secondary Outcomes |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Iron Repletion | Subjects will donate blood donation and undergo 24-hour PTR and receive IV iron-dextran. After 5 months, subjects will donate blood again and undergo 24-hour PTR. Iron-dextran: Approved for clinical use: 1-gram dose IV - diluted in 500 mL, one pint normal saline. Saline: Salt water IV - 500 mL, one pint normal saline. Blood Donation: Standard process of collecting and storing blood and blood components (approximately 450 mL, or a pint of blood). Following donation, the blood will be leukoreduced, packed, and stored in AS-3 solution. 24-hour PTR: The way the FDA determines how good blood is for transfusion is called a "radioactive 51-Chromium 24-hour post-transfusion red cell recovery study." The purpose is to measure how many of the transfused red cells are still in circulation (being pumped by the heart through blood vessels) 24 hours after transfusion. In order to measure the percent of red cells that are still in circulation, a small amount of the donated blood will be radioactively labeled. This will be infused in one arm and then blood will be collected from the other arm at different time points to measure how much of the transfused red cells are still in circulation. |
| 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 | 51-Chromium 24-hour Post-transfusion RBC Recovery of Units | Comparison of the percentage change in 51-Chromium-labeled RBCs remaining from pre- and 24 hour post-transfusion measurement between the Iron Repletion and the Placebo group. The post-transfusion recovery represents the percent of 51-Chromium-labeled RBCs remaining in circulation 24 hours after infusion as compared to an extrapolated time zero measurement. | See participant flow for primary outcome for subject number explanation. | Posted | Median | Inter-Quartile Range | percentage change | Performed 42 days after blood donation |
|
Approximately 6 months of study participation, from first blood donation until final blood draw.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Iron Repletion | Subjects will donate blood donation and undergo 24-hour PTR and receive IV iron-dextran. After 5 months, subjects will donate blood again and undergo 24-hour PTR. Iron-dextran: Approved for clinical use: 1-gram dose IV - diluted in 500 mL, one pint normal saline. Saline: Salt water IV - 500 mL, one pint normal saline. Blood Donation: Standard process of collecting and storing blood and blood components (approximately 450 mL, or a pint of blood). Following donation, the blood will be leukoreduced, packed, and stored in AS-3 solution. 24-hour PTR: The way the FDA determines how good blood is for transfusion is called a "radioactive 51-Chromium 24-hour post-transfusion red cell recovery study." The purpose is to measure how many of the transfused red cells are still in circulation (being pumped by the heart through blood vessels) 24 hours after transfusion. In order to measure the percent of red cells that are still in circulation, a small amount of the donated blood will be radioactively labeled. This will be infused in one arm and then blood will be collected from the other arm at different time points to measure how much of the transfused red cells are still in circulation. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| cardiac stent | Cardiac disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| paresthesia | Nervous system disorders | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Eldad Hod | Columbia University Medical Center | 212-305-4109 | eh2217@cumc.columbia.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 6, 2019 | Dec 6, 2023 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D000090463 | Iron Deficiencies |
| ID | Term |
|---|---|
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D007505 | Iron-Dextran Complex |
| D012965 | Sodium Chloride |
| D000077330 | Saline Solution |
| D000094345 | Blood Donation |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D003911 | Dextrans |
| D005936 | Glucans |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Saline | Drug | Salt water IV - 500 mL, one pint normal saline. |
|
|
| Blood Donation | Procedure | Standard process of collecting and storing blood and blood components (approximately 450 mL, or a pint of blood). Following donation, the blood will be leukoreduced, packed, and stored in AS-3 solution. |
|
|
| 24-hour PTR | Procedure | The way the FDA determines how good blood is for transfusion is called a "radioactive 51-Chromium 24-hour post-transfusion red cell recovery study." The purpose is to measure how many of the transfused red cells are still in circulation (being pumped by the heart through blood vessels) 24 hours after transfusion. In order to measure the percent of red cells that are still in circulation, a small amount of the donated blood will be radioactively labeled. This will be infused in one arm and then blood will be collected from the other arm at different time points to measure how much of the transfused red cells are still in circulation. |
|
|
Measured in a clinical laboratory. Will be used to determine the association between pre-donation ferritin levels and post-transfusion recovery along with the effect of treatment on ferritin levels. |
| End of participation (e.g., ~6 months) |
| Hemoglobin | Measured in a clinical laboratory. Will be used to determine the association between pre-donation hemoglobin levels and post-transfusion recovery along with the effect of treatment on hemoglobin levels. | End of participation (e.g., ~6 months) |
| Reticulocyte Hemoglobin | Measured in a clinical laboratory. Will be used to determine the association between pre-donation reticulocyte hemoglobin levels and post-transfusion recovery along with the effect of treatment on reticulocyte hemoglobin levels. | End of participation (e.g., ~6 months) |
| Soluble Transferrin Receptor | Measured in a clinical laboratory. Will be used to determine the association between pre-donation soluble transferrin receptor levels and post-transfusion recovery along with the effect of treatment on soluble transferrin receptor levels. | End of participation (e.g., ~6 months) |
| Hepcidin | Measured as a research use only test in a research laboratory using an ELISA from Intrinsic LifeSciences. Will be used to determine the association between pre-donation hepcidin levels and post-transfusion recovery along with the effect of treatment on hepcidin levels. | End of participation (e.g., ~6 months) |
| Transferrin Saturation | Measured in a clinical laboratory. Will be used to determine the association between pre-donation transferrin saturation levels and post-transfusion recovery along with the effect of treatment on transferrin saturation levels. | End of participation (e.g., ~6 months) |
| SF-36 Physical Functioning Score | Evaluating subjects' health status using Short Form (SF)-36 question survey. Scores range from 0-100% with higher scores indicating better health. | End of participation (e.g., ~6 months) |
| SF-36 Role Functioning/Physical Score | Evaluating subjects' health status using Short Form (SF)-36 question survey. Scores range from 0-100% with higher scores indicating better health. | End of participation (e.g., ~6 months) |
| SF-36 Role Functioning/Emotional Score | Evaluating subjects' health status using Short Form (SF)-36 question survey. Scores range from 0-100% with higher scores indicating better health. | End of participation (e.g., ~6 months) |
| SF-36 Energy/Fatigue Score | Evaluating subjects' health status using Short Form (SF)-36 question survey. Scores range from 0-100% with higher scores indicating better health. | End of participation (e.g., ~6 months) |
| SF-36 Emotional Well-being Score | Evaluating subjects' health status using Short Form (SF)-36 question survey. Scores range from 0-100% with higher scores indicating better health. | End of participation (e.g., ~6 months) |
| SF-36 Social Functioning Score | Evaluating subjects' health status using Short Form (SF)-36 question survey. Scores range from 0-100% with higher scores indicating better health. | End of participation (e.g., ~6 months) |
| SF-36 Pain Score | Evaluating subjects' health status using Short Form (SF)-36 question survey. Scores range from 0-100% with higher scores indicating better health. | End of participation (e.g., ~6 months) |
| SF-36 General Health Score | Evaluating subjects' health status using Short Form (SF)-36 question survey. Scores range from 0-100% with higher scores indicating better health. | End of participation (e.g., ~6 months) |
| SF-36 Health Change Score | Evaluating subjects' health status using Short Form (SF)-36 question survey. Scores range from 0-100% with higher scores indicating better health. | End of participation (e.g., ~6 months) |
| Beck Depression Inventory (BDI) II Score | Evaluating subjects' depression using the Beck Depression Inventory-II survey. Scores range from 0-63 with higher scores indicating more severe depression. | End of participation (e.g., ~6 months) |
| Beck Anxiety Inventory (BAI) Score | Evaluating subjects' anxiety using the Beck Anxiety Inventory survey. Scores range from 0-63 with higher scores indicating more severe anxiety. | End of participation (e.g., ~6 months) |
| Global Fatigue Index (GFI) Score | Evaluating subjects' fatigue using the Multidimensional Assessment of Fatigue (MAF) survey. Scores range from 1-50 with higher scores indicating more severe fatigue. | End of participation (e.g., ~6 months) |
| Restless Legs Syndrome Rating Scale Score | Evaluating subjects' symptoms of restless leg syndrome using the Restless Legs Syndrome Rating Scale survey. Scores range from 0-40 with higher scores indicating more severe symptoms. | End of participation (e.g., ~6 months) |
| 33657208 | Derived | Roussel C, Morel A, Dussiot M, Marin M, Colard M, Fricot-Monsinjon A, Martinez A, Chambrion C, Henry B, Casimir M, Volle G, Depond M, Dokmak S, Paye F, Sauvanet A, Le Van Kim C, Colin Y, Georgeault S, Roingeard P, Spitalnik SL, Ndour PA, Hermine O, Hod EA, Buffet PA, Amireault P. Rapid clearance of storage-induced microerythrocytes alters transfusion recovery. Blood. 2021 Apr 29;137(17):2285-2298. doi: 10.1182/blood.2020008563. |
| Chromium labeling failure |
|
| COVID-19/Illness |
|
| Protocol Violation |
|
| Subject did not meet donor criteria |
|
| NOT COMPLETED |
|
|
| BG001 | Placebo | Subjects will donate blood donation and undergo 24-hour PTR and receive IV saline. After 5 months, subjects will donate blood again and undergo 24-hour PTR. Iron-dextran: Approved for clinical use: 1-gram dose IV - diluted in 500 mL, one pint normal saline. Saline: Salt water IV - 500 mL, one pint normal saline. Blood Donation: Standard process of collecting and storing blood and blood components (approximately 450 mL, or a pint of blood). Following donation, the blood will be leukoreduced, packed, and stored in AS-3 solution. 24-hour PTR: The way the FDA determines how good blood is for transfusion is called a "radioactive 51-Chromium 24-hour post-transfusion red cell recovery study." The purpose is to measure how many of the transfused red cells are still in circulation (being pumped by the heart through blood vessels) 24 hours after transfusion. In order to measure the percent of red cells that are still in circulation, a small amount of the donated blood will be radioactively labeled. This will be infused in one arm and then blood will be collected from the other arm at different time points to measure how much of the transfused red cells are still in circulation. |
| BG002 | 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 |
|
| Weight | Median | Inter-Quartile Range | kg |
|
| OG001 | Placebo | Subjects will donate blood donation and undergo 24-hour PTR and receive IV saline. After 5 months, subjects will donate blood again and undergo 24-hour PTR. Iron-dextran: Approved for clinical use: 1-gram dose IV - diluted in 500 mL, one pint normal saline. Saline: Salt water IV - 500 mL, one pint normal saline. Blood Donation: Standard process of collecting and storing blood and blood components (approximately 450 mL, or a pint of blood). Following donation, the blood will be leukoreduced, packed, and stored in AS-3 solution. 24-hour PTR: The way the FDA determines how good blood is for transfusion is called a "radioactive 51-Chromium 24-hour post-transfusion red cell recovery study." The purpose is to measure how many of the transfused red cells are still in circulation (being pumped by the heart through blood vessels) 24 hours after transfusion. In order to measure the percent of red cells that are still in circulation, a small amount of the donated blood will be radioactively labeled. This will be infused in one arm and then blood will be collected from the other arm at different time points to measure how much of the transfused red cells are still in circulation. |
|
|
| Secondary | RBC Zinc Protoporphyrin Levels | Measured in a clinical laboratory. Will be used to determine the association between pre-donation zinc protoporphyrin levels and post-transfusion recovery along with the effect of treatment on zinc protoporphyrin levels. | See participant flow for secondary outcomes for subject number explanation. | Posted | Median | Inter-Quartile Range | μMol/mol heme | End of participation (e.g., ~6 months) |
|
|
|
| Secondary | Serum Ferritin | Measured in a clinical laboratory. Will be used to determine the association between pre-donation ferritin levels and post-transfusion recovery along with the effect of treatment on ferritin levels. | See participant flow for secondary outcomes for subject number explanation. | Posted | Median | Inter-Quartile Range | ug/L | End of participation (e.g., ~6 months) |
|
|
|
| Secondary | Hemoglobin | Measured in a clinical laboratory. Will be used to determine the association between pre-donation hemoglobin levels and post-transfusion recovery along with the effect of treatment on hemoglobin levels. | See participant flow for secondary outcomes for subject number explanation. | Posted | Median | Inter-Quartile Range | g/dL | End of participation (e.g., ~6 months) |
|
|
|
| Secondary | Reticulocyte Hemoglobin | Measured in a clinical laboratory. Will be used to determine the association between pre-donation reticulocyte hemoglobin levels and post-transfusion recovery along with the effect of treatment on reticulocyte hemoglobin levels. | See participant flow for secondary outcomes for subject number explanation. | Posted | Median | Inter-Quartile Range | g/dL | End of participation (e.g., ~6 months) |
|
|
|
| Secondary | Soluble Transferrin Receptor | Measured in a clinical laboratory. Will be used to determine the association between pre-donation soluble transferrin receptor levels and post-transfusion recovery along with the effect of treatment on soluble transferrin receptor levels. | See participant flow for secondary outcomes for subject number explanation. | Posted | Median | Inter-Quartile Range | mg/L | End of participation (e.g., ~6 months) |
|
|
|
| Secondary | Hepcidin | Measured as a research use only test in a research laboratory using an ELISA from Intrinsic LifeSciences. Will be used to determine the association between pre-donation hepcidin levels and post-transfusion recovery along with the effect of treatment on hepcidin levels. | See participant flow for secondary outcomes for subject number explanation. | Posted | Median | Inter-Quartile Range | ng/mL | End of participation (e.g., ~6 months) |
|
|
|
| Secondary | Transferrin Saturation | Measured in a clinical laboratory. Will be used to determine the association between pre-donation transferrin saturation levels and post-transfusion recovery along with the effect of treatment on transferrin saturation levels. | See participant flow for secondary outcomes for subject number explanation. | Posted | Median | Inter-Quartile Range | percent | End of participation (e.g., ~6 months) |
|
|
|
| Secondary | SF-36 Physical Functioning Score | Evaluating subjects' health status using Short Form (SF)-36 question survey. Scores range from 0-100% with higher scores indicating better health. | See participant flow for secondary outcomes for subject number explanation. | Posted | Least Squares Mean | 95% Confidence Interval | percent | End of participation (e.g., ~6 months) |
|
|
|
| Secondary | SF-36 Role Functioning/Physical Score | Evaluating subjects' health status using Short Form (SF)-36 question survey. Scores range from 0-100% with higher scores indicating better health. | See participant flow for secondary outcomes for subject number explanation. | Posted | Least Squares Mean | 95% Confidence Interval | percent | End of participation (e.g., ~6 months) |
|
|
|
| Secondary | SF-36 Role Functioning/Emotional Score | Evaluating subjects' health status using Short Form (SF)-36 question survey. Scores range from 0-100% with higher scores indicating better health. | See participant flow for secondary outcomes for subject number explanation. | Posted | Least Squares Mean | 95% Confidence Interval | percent | End of participation (e.g., ~6 months) |
|
|
|
| Secondary | SF-36 Energy/Fatigue Score | Evaluating subjects' health status using Short Form (SF)-36 question survey. Scores range from 0-100% with higher scores indicating better health. | See participant flow for secondary outcomes for subject number explanation. | Posted | Least Squares Mean | 95% Confidence Interval | percent | End of participation (e.g., ~6 months) |
|
|
|
| Secondary | SF-36 Emotional Well-being Score | Evaluating subjects' health status using Short Form (SF)-36 question survey. Scores range from 0-100% with higher scores indicating better health. | See participant flow for secondary outcomes for subject number explanation. | Posted | Least Squares Mean | 95% Confidence Interval | percent | End of participation (e.g., ~6 months) |
|
|
|
| Secondary | SF-36 Social Functioning Score | Evaluating subjects' health status using Short Form (SF)-36 question survey. Scores range from 0-100% with higher scores indicating better health. | See participant flow for secondary outcomes for subject number explanation. | Posted | Least Squares Mean | Inter-Quartile Range | percent | End of participation (e.g., ~6 months) |
|
|
|
| Secondary | SF-36 Pain Score | Evaluating subjects' health status using Short Form (SF)-36 question survey. Scores range from 0-100% with higher scores indicating better health. | See participant flow for secondary outcomes for subject number explanation. | Posted | Least Squares Mean | 95% Confidence Interval | percent | End of participation (e.g., ~6 months) |
|
|
|
| Secondary | SF-36 General Health Score | Evaluating subjects' health status using Short Form (SF)-36 question survey. Scores range from 0-100% with higher scores indicating better health. | See participant flow for secondary outcomes for subject number explanation. | Posted | Least Squares Mean | 95% Confidence Interval | percent | End of participation (e.g., ~6 months) |
|
|
|
| Secondary | SF-36 Health Change Score | Evaluating subjects' health status using Short Form (SF)-36 question survey. Scores range from 0-100% with higher scores indicating better health. | See participant flow for secondary outcomes for subject number explanation. | Posted | Least Squares Mean | 95% Confidence Interval | percent | End of participation (e.g., ~6 months) |
|
|
|
| Secondary | Beck Depression Inventory (BDI) II Score | Evaluating subjects' depression using the Beck Depression Inventory-II survey. Scores range from 0-63 with higher scores indicating more severe depression. | See participant flow for secondary outcomes for subject number explanation. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | End of participation (e.g., ~6 months) |
|
|
|
| Secondary | Beck Anxiety Inventory (BAI) Score | Evaluating subjects' anxiety using the Beck Anxiety Inventory survey. Scores range from 0-63 with higher scores indicating more severe anxiety. | See participant flow for secondary outcomes for subject number explanation. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | End of participation (e.g., ~6 months) |
|
|
|
| Secondary | Global Fatigue Index (GFI) Score | Evaluating subjects' fatigue using the Multidimensional Assessment of Fatigue (MAF) survey. Scores range from 1-50 with higher scores indicating more severe fatigue. | See participant flow for secondary outcomes for subject number explanation. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | End of participation (e.g., ~6 months) |
|
|
|
| Secondary | Restless Legs Syndrome Rating Scale Score | Evaluating subjects' symptoms of restless leg syndrome using the Restless Legs Syndrome Rating Scale survey. Scores range from 0-40 with higher scores indicating more severe symptoms. | See participant flow for secondary outcomes for subject number explanation. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | End of participation (e.g., ~6 months) |
|
|
|
| 0 |
| 39 |
| 0 |
| 39 |
| 1 |
| 39 |
| EG001 | Placebo | Subjects will donate blood donation and undergo 24-hour PTR and receive IV saline. After 5 months, subjects will donate blood again and undergo 24-hour PTR. Iron-dextran: Approved for clinical use: 1-gram dose IV - diluted in 500 mL, one pint normal saline. Saline: Salt water IV - 500 mL, one pint normal saline. Blood Donation: Standard process of collecting and storing blood and blood components (approximately 450 mL, or a pint of blood). Following donation, the blood will be leukoreduced, packed, and stored in AS-3 solution. 24-hour PTR: The way the FDA determines how good blood is for transfusion is called a "radioactive 51-Chromium 24-hour post-transfusion red cell recovery study." The purpose is to measure how many of the transfused red cells are still in circulation (being pumped by the heart through blood vessels) 24 hours after transfusion. In order to measure the percent of red cells that are still in circulation, a small amount of the donated blood will be radioactively labeled. This will be infused in one arm and then blood will be collected from the other arm at different time points to measure how much of the transfused red cells are still in circulation. | 0 | 40 | 1 | 40 | 3 | 40 |
| headache | Nervous system disorders | Non-systematic Assessment |
|
| diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
|
Not provided
Not provided
| D011134 |
| Polysaccharides |
| D002241 | Carbohydrates |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D009927 | Tissue and Organ Procurement |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |