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

• Status: Enrolling by invitation
• Trial end date: 2021-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Columbia University
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); New York Blood Center
• Treatments: Dextrans; Iron; Iron-Dextran Complex

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.