Clinical trial
A Randomized Trial to Determine if RBCs From Donors With Iron Deficient Erythropoiesis Have Decreased Post-transfusion RBC Recovery and Whether Iron Repletion Improves Recovery
Name
AAAQ8875
Description
Primary Hypothesis
* The 24-hour post-transfusion RBC recovery of units obtained from donors exhibiting iron-deficient erythropoiesis will not meet FDA standards for clinical use.
* The 24-hour post-transfusion RBC recovery of units obtained after intravenous iron repletion will improve significantly and will meet FDA standards for clinical use.
Trial arms
Trial start
2017-01-01
Estimated PCD
2021-10-05
Trial end
2021-10-05
Status
Completed
Treatment
Iron-dextran
Approved for clinical use: 1-gram dose IV - diluted in 500 mL, one pint normal saline.
Arms:
Iron repletion, Placebo
Other names:
INFeD, Low molecular weight iron-dextran
Saline
Salt water IV - 500 mL, one pint normal saline.
Arms:
Iron repletion, Placebo
Other names:
Placebo, 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.
Arms:
Iron repletion, Placebo
Other names:
Red blood cell donation
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.
Arms:
Iron repletion, Placebo
Other names:
24-hour post-transfusion red cell recovery
Size
79
Primary endpoint
51-Chromium 24-hour Post-transfusion RBC Recovery of Units
Performed 42 days after blood donation
Eligibility criteria
Inclusion Criteria:
1. 18-75 years old;
2. healthy (by self report);
3. body weight \>110 lbs;
4. female hematocrit \>=38%, male hematocrit \>39%;
5. frequent blood donor (men ≥2 and female ≥1 RBC unit donations in past year);
6. ferritin \<=15 ng/mL; and
7. zinc protoporphyrin \>=60 µmol/mol heme.
Exclusion Criteria:
1. ineligible for donation based on the New York Blood Center donor autologous questionnaire;
2. taking iron supplementation;
3. C-reactive protein \>10 mg/L;
4. sickle cell trait;
5. systolic blood pressure \>180 or \<90 mm Hg, diastolic blood pressure \>100 or \<50 mm Hg;
6. heart rate \<50 or \>100;
7. temperature \>99.5°F prior to donation;
8. temperature \>100.4°F or subjective feeling of illness prior to 51-Chromium 24-hour RBC recovery study (to avoid the subject having a concurrent illness that may affect post-transfusion recovery);
9. positive results on standard blood donor infectious disease testing;
10. pregnancy;
11. taking, or planning to take, iron supplements; and
12. history of severe asthma requiring hospitalization, allergic eczema (atopic dermatitis), or other atopic allergy causing anaphylaxis.
Protocol
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Updated at
2024-06-12
1 organization
Organization
Columbia University