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

Columbia University

Status: Completed

Conditions: Iron Deficiency

Treatments: Drug: Saline; Drug: Iron-dextran; Procedure: 24-hour PTR; Procedure: Blood Donation

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02889133

AAAQ8875

1R01HL133049-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 79 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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79 participants in 2 patient groups, including a placebo group

Iron repletion

Active Comparator group

Description:

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.

Treatment:

Procedure: Blood Donation

Procedure: 24-hour PTR

Drug: Saline

Drug: Iron-dextran

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Procedure: Blood Donation

Procedure: 24-hour PTR

Drug: Saline

Drug: Iron-dextran