Trial Outcomes & Findings for Donor Iron Deficiency Study - Red Blood Cells From Iron-deficient Donors: Recovery and Storage Quality (NCT NCT02889133)
NCT ID: NCT02889133
Last Updated: 2024-06-12
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
79 participants
Primary outcome timeframe
Performed 42 days after blood donation
Results posted on
2024-06-12
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Completed Primary Outcome
STARTED
|
39
|
40
|
|
Completed Primary Outcome
COMPLETED
|
29
|
28
|
|
Completed Primary Outcome
NOT COMPLETED
|
10
|
12
|
|
Completed Secondary Outcomes
STARTED
|
39
|
40
|
|
Completed Secondary Outcomes
COMPLETED
|
33
|
35
|
|
Completed Secondary Outcomes
NOT COMPLETED
|
6
|
5
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Completed Primary Outcome
Lost to Follow-up
|
1
|
1
|
|
Completed Primary Outcome
Manufacturing error
|
3
|
8
|
|
Completed Primary Outcome
Chromium labeling failure
|
1
|
0
|
|
Completed Primary Outcome
COVID-19/Illness
|
4
|
2
|
|
Completed Primary Outcome
Protocol Violation
|
1
|
0
|
|
Completed Primary Outcome
Subject did not meet donor criteria
|
0
|
1
|
|
Completed Secondary Outcomes
Lost to Follow-up
|
1
|
1
|
|
Completed Secondary Outcomes
COVID-19/illness
|
4
|
2
|
|
Completed Secondary Outcomes
Subject could not donate blood after randomization
|
0
|
2
|
|
Completed Secondary Outcomes
Protocol Violation
|
1
|
0
|
Baseline Characteristics
Donor Iron Deficiency Study - Red Blood Cells From Iron-deficient Donors: Recovery and Storage Quality
Baseline characteristics by cohort
| Measure |
Iron Repletion
n=39 Participants
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.
|
Placebo
n=40 Participants
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.
|
Total
n=79 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
33 years
n=99 Participants
|
34 years
n=107 Participants
|
34 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
54 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
33 Participants
n=99 Participants
|
37 Participants
n=107 Participants
|
70 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
25 Participants
n=99 Participants
|
31 Participants
n=107 Participants
|
56 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
7 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
39 participants
n=99 Participants
|
40 participants
n=107 Participants
|
79 participants
n=206 Participants
|
|
Weight
|
73 kg
n=99 Participants
|
66 kg
n=107 Participants
|
68 kg
n=206 Participants
|
PRIMARY outcome
Timeframe: Performed 42 days after blood donationPopulation: See participant flow for primary outcome for subject number explanation.
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.
Outcome measures
| Measure |
Iron Repletion
n=29 Participants
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.
|
Placebo
n=28 Participants
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.
|
|---|---|---|
|
51-Chromium 24-hour Post-transfusion RBC Recovery of Units
|
1.6 percentage change
Interval -0.5 to 3.8
|
-0.4 percentage change
Interval -2.0 to 1.2
|
SECONDARY outcome
Timeframe: End of participation (e.g., ~6 months)Population: See participant flow for secondary outcomes for subject number explanation.
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.
Outcome measures
| Measure |
Iron Repletion
n=33 Participants
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.
|
Placebo
n=35 Participants
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.
|
|---|---|---|
|
RBC Zinc Protoporphyrin Levels
|
54 μMol/mol heme
Interval 47.0 to 65.0
|
102 μMol/mol heme
Interval 80.0 to 136.0
|
SECONDARY outcome
Timeframe: End of participation (e.g., ~6 months)Population: See participant flow for secondary outcomes for subject number explanation.
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.
Outcome measures
| Measure |
Iron Repletion
n=33 Participants
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.
|
Placebo
n=35 Participants
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.
|
|---|---|---|
|
Serum Ferritin
|
25.1 ug/L
Interval 20.4 to 39.6
|
8.4 ug/L
Interval 6.3 to 10.5
|
SECONDARY outcome
Timeframe: End of participation (e.g., ~6 months)Population: See participant flow for secondary outcomes for subject number explanation.
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.
Outcome measures
| Measure |
Iron Repletion
n=33 Participants
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.
|
Placebo
n=35 Participants
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.
|
|---|---|---|
|
Hemoglobin
|
13.9 g/dL
Interval 12.9 to 14.4
|
11.2 g/dL
Interval 10.2 to 12.7
|
SECONDARY outcome
Timeframe: End of participation (e.g., ~6 months)Population: See participant flow for secondary outcomes for subject number explanation.
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.
Outcome measures
| Measure |
Iron Repletion
n=33 Participants
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.
|
Placebo
n=35 Participants
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.
|
|---|---|---|
|
Reticulocyte Hemoglobin
|
33.2 g/dL
Interval 32.3 to 34.5
|
29.0 g/dL
Interval 25.8 to 31.6
|
SECONDARY outcome
Timeframe: End of participation (e.g., ~6 months)Population: See participant flow for secondary outcomes for subject number explanation.
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.
Outcome measures
| Measure |
Iron Repletion
n=33 Participants
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.
|
Placebo
n=35 Participants
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.
|
|---|---|---|
|
Soluble Transferrin Receptor
|
3.6 mg/L
Interval 3.2 to 4.5
|
7.0 mg/L
Interval 5.2 to 9.6
|
SECONDARY outcome
Timeframe: End of participation (e.g., ~6 months)Population: See participant flow for secondary outcomes for subject number explanation.
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.
Outcome measures
| Measure |
Iron Repletion
n=33 Participants
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.
|
Placebo
n=35 Participants
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.
|
|---|---|---|
|
Hepcidin
|
20.3 ng/mL
Interval 16.2 to 31.6
|
15.5 ng/mL
Interval 13.7 to 18.8
|
SECONDARY outcome
Timeframe: End of participation (e.g., ~6 months)Population: See participant flow for secondary outcomes for subject number explanation.
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.
Outcome measures
| Measure |
Iron Repletion
n=33 Participants
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.
|
Placebo
n=35 Participants
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.
|
|---|---|---|
|
Transferrin Saturation
|
18.8 percent
Interval 15.1 to 28.5
|
9.1 percent
Interval 7.0 to 13.7
|
SECONDARY outcome
Timeframe: End of participation (e.g., ~6 months)Population: See participant flow for secondary outcomes for subject number explanation.
Evaluating subjects' health status using Short Form (SF)-36 question survey. Scores range from 0-100% with higher scores indicating better health.
Outcome measures
| Measure |
Iron Repletion
n=33 Participants
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.
|
Placebo
n=35 Participants
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.
|
|---|---|---|
|
SF-36 Physical Functioning Score
|
94.83 percent
Interval 91.62 to 98.04
|
94.87 percent
Interval 91.74 to 98.0
|
SECONDARY outcome
Timeframe: End of participation (e.g., ~6 months)Population: See participant flow for secondary outcomes for subject number explanation.
Evaluating subjects' health status using Short Form (SF)-36 question survey. Scores range from 0-100% with higher scores indicating better health.
Outcome measures
| Measure |
Iron Repletion
n=33 Participants
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.
|
Placebo
n=35 Participants
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.
|
|---|---|---|
|
SF-36 Role Functioning/Physical Score
|
91.29 percent
Interval 83.87 to 98.7
|
90.36 percent
Interval 83.15 to 97.57
|
SECONDARY outcome
Timeframe: End of participation (e.g., ~6 months)Population: See participant flow for secondary outcomes for subject number explanation.
Evaluating subjects' health status using Short Form (SF)-36 question survey. Scores range from 0-100% with higher scores indicating better health.
Outcome measures
| Measure |
Iron Repletion
n=33 Participants
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.
|
Placebo
n=35 Participants
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.
|
|---|---|---|
|
SF-36 Role Functioning/Emotional Score
|
85.58 percent
Interval 75.3 to 95.86
|
81.9 percent
Interval 71.9 to 91.9
|
SECONDARY outcome
Timeframe: End of participation (e.g., ~6 months)Population: See participant flow for secondary outcomes for subject number explanation.
Evaluating subjects' health status using Short Form (SF)-36 question survey. Scores range from 0-100% with higher scores indicating better health.
Outcome measures
| Measure |
Iron Repletion
n=33 Participants
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.
|
Placebo
n=35 Participants
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.
|
|---|---|---|
|
SF-36 Energy/Fatigue Score
|
65.94 percent
Interval 59.5 to 72.38
|
61.30 percent
Interval 55.0 to 67.59
|
SECONDARY outcome
Timeframe: End of participation (e.g., ~6 months)Population: See participant flow for secondary outcomes for subject number explanation.
Evaluating subjects' health status using Short Form (SF)-36 question survey. Scores range from 0-100% with higher scores indicating better health.
Outcome measures
| Measure |
Iron Repletion
n=33 Participants
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.
|
Placebo
n=35 Participants
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.
|
|---|---|---|
|
SF-36 Emotional Well-being Score
|
79.2 percent
Interval 73.6 to 84.8
|
76.7 percent
Interval 71.2 to 82.2
|
SECONDARY outcome
Timeframe: End of participation (e.g., ~6 months)Population: See participant flow for secondary outcomes for subject number explanation.
Evaluating subjects' health status using Short Form (SF)-36 question survey. Scores range from 0-100% with higher scores indicating better health.
Outcome measures
| Measure |
Iron Repletion
n=33 Participants
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.
|
Placebo
n=35 Participants
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.
|
|---|---|---|
|
SF-36 Social Functioning Score
|
90.7 percent
Interval 84.5 to 96.9
|
87.97 percent
Interval 81.9 to 94.0
|
SECONDARY outcome
Timeframe: End of participation (e.g., ~6 months)Population: See participant flow for secondary outcomes for subject number explanation.
Evaluating subjects' health status using Short Form (SF)-36 question survey. Scores range from 0-100% with higher scores indicating better health.
Outcome measures
| Measure |
Iron Repletion
n=33 Participants
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.
|
Placebo
n=35 Participants
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.
|
|---|---|---|
|
SF-36 Pain Score
|
86.9 percent
Interval 81.3 to 92.5
|
88.2 percent
Interval 82.8 to 93.7
|
SECONDARY outcome
Timeframe: End of participation (e.g., ~6 months)Population: See participant flow for secondary outcomes for subject number explanation.
Evaluating subjects' health status using Short Form (SF)-36 question survey. Scores range from 0-100% with higher scores indicating better health.
Outcome measures
| Measure |
Iron Repletion
n=33 Participants
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.
|
Placebo
n=35 Participants
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.
|
|---|---|---|
|
SF-36 General Health Score
|
80.3 percent
Interval 74.3 to 86.3
|
73.0 percent
Interval 67.0 to 78.9
|
SECONDARY outcome
Timeframe: End of participation (e.g., ~6 months)Population: See participant flow for secondary outcomes for subject number explanation.
Evaluating subjects' health status using Short Form (SF)-36 question survey. Scores range from 0-100% with higher scores indicating better health.
Outcome measures
| Measure |
Iron Repletion
n=33 Participants
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.
|
Placebo
n=35 Participants
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.
|
|---|---|---|
|
SF-36 Health Change Score
|
61.3 percent
Interval 55.4 to 67.2
|
54.6 percent
Interval 48.8 to 60.4
|
SECONDARY outcome
Timeframe: End of participation (e.g., ~6 months)Population: See participant flow for secondary outcomes for subject number explanation.
Evaluating subjects' depression using the Beck Depression Inventory-II survey. Scores range from 0-63 with higher scores indicating more severe depression.
Outcome measures
| Measure |
Iron Repletion
n=33 Participants
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.
|
Placebo
n=35 Participants
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.
|
|---|---|---|
|
Beck Depression Inventory (BDI) II Score
|
4.4 score on a scale
Interval 2.0 to 6.9
|
4.8 score on a scale
Interval 2.4 to 7.2
|
SECONDARY outcome
Timeframe: End of participation (e.g., ~6 months)Population: See participant flow for secondary outcomes for subject number explanation.
Evaluating subjects' anxiety using the Beck Anxiety Inventory survey. Scores range from 0-63 with higher scores indicating more severe anxiety.
Outcome measures
| Measure |
Iron Repletion
n=33 Participants
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.
|
Placebo
n=35 Participants
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.
|
|---|---|---|
|
Beck Anxiety Inventory (BAI) Score
|
3.7 score on a scale
Interval 1.1 to 6.3
|
6.4 score on a scale
Interval 3.8 to 8.9
|
SECONDARY outcome
Timeframe: End of participation (e.g., ~6 months)Population: See participant flow for secondary outcomes for subject number explanation.
Evaluating subjects' fatigue using the Multidimensional Assessment of Fatigue (MAF) survey. Scores range from 1-50 with higher scores indicating more severe fatigue.
Outcome measures
| Measure |
Iron Repletion
n=33 Participants
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.
|
Placebo
n=35 Participants
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.
|
|---|---|---|
|
Global Fatigue Index (GFI) Score
|
11.0 score on a scale
Interval 7.4 to 14.5
|
13.9 score on a scale
Interval 10.4 to 17.4
|
SECONDARY outcome
Timeframe: End of participation (e.g., ~6 months)Population: See participant flow for secondary outcomes for subject number explanation.
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.
Outcome measures
| Measure |
Iron Repletion
n=33 Participants
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.
|
Placebo
n=35 Participants
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.
|
|---|---|---|
|
Restless Legs Syndrome Rating Scale Score
|
.48 score on a scale
Interval -0.44 to 1.39
|
1.06 score on a scale
Interval 0.16 to 2.0
|
Adverse Events
Iron Repletion
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Iron Repletion
n=39 participants at risk
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.
|
Placebo
n=40 participants at risk
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.
|
|---|---|---|
|
Cardiac disorders
cardiac stent
|
0.00%
0/39 • Approximately 6 months of study participation, from first blood donation until final blood draw.
|
2.5%
1/40 • Number of events 1 • Approximately 6 months of study participation, from first blood donation until final blood draw.
|
Other adverse events
| Measure |
Iron Repletion
n=39 participants at risk
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.
|
Placebo
n=40 participants at risk
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.
|
|---|---|---|
|
Nervous system disorders
paresthesia
|
2.6%
1/39 • Number of events 1 • Approximately 6 months of study participation, from first blood donation until final blood draw.
|
2.5%
1/40 • Number of events 1 • Approximately 6 months of study participation, from first blood donation until final blood draw.
|
|
Nervous system disorders
headache
|
0.00%
0/39 • Approximately 6 months of study participation, from first blood donation until final blood draw.
|
2.5%
1/40 • Number of events 1 • Approximately 6 months of study participation, from first blood donation until final blood draw.
|
|
Gastrointestinal disorders
diarrhea
|
0.00%
0/39 • Approximately 6 months of study participation, from first blood donation until final blood draw.
|
2.5%
1/40 • Number of events 1 • Approximately 6 months of study participation, from first blood donation until final blood draw.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place