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Completed

NCT Number: NCT02889133

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

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.

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Key information

Conditions

Iron Deficiency Iron Deficiencies Iron Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Columbia University Irving Medical Center

New York, 10032, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18-75 years old;
  • healthy (by self report);
  • body weight >110 lbs;
  • female hematocrit >=38%, male hematocrit >39%;
  • frequent blood donor (men ≥2 and female ≥1 RBC unit donations in past year);
  • ferritin <=15 ng/mL; and
  • zinc protoporphyrin >=60 µmol/mol heme.

Exclusion criteria

  • ineligible for donation based on the New York Blood Center donor autologous questionnaire;
  • taking iron supplementation;
  • C-reactive protein >10 mg/L;
  • sickle cell trait;
  • systolic blood pressure >180 or <90 mm Hg, diastolic blood pressure >100 or <50 mm Hg;
  • heart rate <50 or >100;
  • temperature >99.5°F prior to donation;
  • 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);
  • positive results on standard blood donor infectious disease testing;
  • pregnancy;
  • taking, or planning to take, iron supplements; and
  • history of severe asthma requiring hospitalization, allergic eczema (atopic dermatitis), or other atopic allergy causing anaphylaxis.

Treatment and study plan

Iron-dextran

Drug

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

Other names: INFeD, Low molecular weight iron-dextran

Saline

Drug

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

Other names: Placebo, Normal Saline

Blood Donation

Procedure

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.

Other names: Red blood cell donation

24-hour PTR

Procedure

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.

Other names: 24-hour post-transfusion red cell recovery

Primary outcomes

  1. 51-Chromium 24-hour Post-transfusion RBC Recovery of Units

    Time frame: Performed 42 days after blood donation

    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.

Secondary outcomes

  1. RBC Zinc Protoporphyrin Levels

    Time frame: End of participation (e.g., ~6 months)

    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.

  2. Serum Ferritin

    Time frame: End of participation (e.g., ~6 months)

    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.

  3. Hemoglobin

    Time frame: End of participation (e.g., ~6 months)

    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.

  4. Reticulocyte Hemoglobin

    Time frame: End of participation (e.g., ~6 months)

    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.

  5. Soluble Transferrin Receptor

    Time frame: End of participation (e.g., ~6 months)

    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.

  6. Hepcidin

    Time frame: End of participation (e.g., ~6 months)

    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.

  7. Transferrin Saturation

    Time frame: End of participation (e.g., ~6 months)

    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.

  8. SF-36 Physical Functioning Score

    Time frame: End of participation (e.g., ~6 months)

    Evaluating subjects' health status using Short Form (SF)-36 question survey. Scores range from 0-100% with higher scores indicating better health.

  9. SF-36 Role Functioning/Physical Score

    Time frame: End of participation (e.g., ~6 months)

    Evaluating subjects' health status using Short Form (SF)-36 question survey. Scores range from 0-100% with higher scores indicating better health.

  10. SF-36 Role Functioning/Emotional Score

    Time frame: End of participation (e.g., ~6 months)

    Evaluating subjects' health status using Short Form (SF)-36 question survey. Scores range from 0-100% with higher scores indicating better health.

  11. SF-36 Energy/Fatigue Score

    Time frame: End of participation (e.g., ~6 months)

    Evaluating subjects' health status using Short Form (SF)-36 question survey. Scores range from 0-100% with higher scores indicating better health.

  12. SF-36 Emotional Well-being Score

    Time frame: End of participation (e.g., ~6 months)

    Evaluating subjects' health status using Short Form (SF)-36 question survey. Scores range from 0-100% with higher scores indicating better health.

  13. SF-36 Social Functioning Score

    Time frame: End of participation (e.g., ~6 months)

    Evaluating subjects' health status using Short Form (SF)-36 question survey. Scores range from 0-100% with higher scores indicating better health.

  14. SF-36 Pain Score

    Time frame: End of participation (e.g., ~6 months)

    Evaluating subjects' health status using Short Form (SF)-36 question survey. Scores range from 0-100% with higher scores indicating better health.

  15. SF-36 General Health Score

    Time frame: End of participation (e.g., ~6 months)

    Evaluating subjects' health status using Short Form (SF)-36 question survey. Scores range from 0-100% with higher scores indicating better health.

  16. SF-36 Health Change Score

    Time frame: End of participation (e.g., ~6 months)

    Evaluating subjects' health status using Short Form (SF)-36 question survey. Scores range from 0-100% with higher scores indicating better health.

  17. Beck Depression Inventory (BDI) II Score

    Time frame: End of participation (e.g., ~6 months)

    Evaluating subjects' depression using the Beck Depression Inventory-II survey. Scores range from 0-63 with higher scores indicating more severe depression.

  18. Beck Anxiety Inventory (BAI) Score

    Time frame: End of participation (e.g., ~6 months)

    Evaluating subjects' anxiety using the Beck Anxiety Inventory survey. Scores range from 0-63 with higher scores indicating more severe anxiety.

  19. Global Fatigue Index (GFI) Score

    Time frame: End of participation (e.g., ~6 months)

    Evaluating subjects' fatigue using the Multidimensional Assessment of Fatigue (MAF) survey. Scores range from 1-50 with higher scores indicating more severe fatigue.

  20. Restless Legs Syndrome Rating Scale Score

    Time frame: End of participation (e.g., ~6 months)

    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.

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)
  • New York Blood Center

Registry information

Official study title

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

Acronym: DIDS

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Sep 5, 2016
Registry last updated
Jun 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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