Donor Iron Deficiency Study - Red Blood Cells From Iron-deficient Donors: Recovery and Storage Quality

Columbia University79 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

TRIPLE

Enrollment

Conditions

Iron Deficiency

Interventions

Iron-dextranDRUG

Approved for clinical use: 1-gram dose IV - diluted in 500 mL, one pint normal saline.

SalineDRUG

Salt water IV - 500 mL, one pint normal saline.

Blood DonationPROCEDURE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Columbia University Irving Medical Center

New York, New York, United States

Outcomes

Primary Outcomes

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.

Time frame: Performed 42 days after blood donation

Secondary Outcomes

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.