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

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ClinicalTrials.gov Identifier: NCT02889133
Recruitment Status : Enrolling by invitation
First Posted : September 5, 2016
Last Update Posted : February 4, 2019
Sponsor:
Collaborators:
New York Blood Center
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Eldad Arie Hod, Columbia University

Brief 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.

Condition or disease Intervention/treatment Phase
Iron Deficiency Drug: Iron-dextran Drug: Saline Procedure: Blood Donation Procedure: 24-hour PTR Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official 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
Actual Study Start Date : January 2017
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Iron repletion
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.
Drug: Iron-dextran
Approved for clinical use: 1-gram dose IV - diluted in 500 mL, one pint normal saline.
Other Names:
  • INFeD
  • Low molecular weight iron-dextran

Drug: Saline
Salt water IV - 500 mL, one pint normal saline.
Other Names:
  • Placebo
  • Normal Saline

Procedure: 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.
Other Name: Red blood cell donation

Procedure: 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.
Other Name: 24-hour post-transfusion red cell recovery

Placebo Comparator: Placebo
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.
Drug: Iron-dextran
Approved for clinical use: 1-gram dose IV - diluted in 500 mL, one pint normal saline.
Other Names:
  • INFeD
  • Low molecular weight iron-dextran

Drug: Saline
Salt water IV - 500 mL, one pint normal saline.
Other Names:
  • Placebo
  • Normal Saline

Procedure: 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.
Other Name: Red blood cell donation

Procedure: 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.
Other Name: 24-hour post-transfusion red cell recovery




Primary Outcome Measures :
  1. 51-Chromium 24-hour post-transfusion RBC recovery of units [ Time Frame: Performed 42 days after blood donation ]

Secondary Outcome Measures :
  1. RBC zinc protoporphyrin levels (donation 1) [ Time Frame: Day 0 ]
    To determine the association between pre-donation zinc protoporphyrin levels and post-transfusion recovery

  2. RBC zinc protoporphyrin levels (PTR 1) [ Time Frame: 42 days - after first blood donation ]
    To determine the association between pre-donation zinc protoporphyrin levels and post-transfusion recovery

  3. RBC zinc protoporphyrin levels (donation 2) [ Time Frame: 5 months and 42 days - prior to second blood donation ]
    To determine the association between pre-donation zinc protoporphyrin levels and post-transfusion recovery

  4. RBC zinc protoporphyrin levels (PTR 2) [ Time Frame: 5 months and 84 days - prior to second post-transfusion recovery study ]
    To determine the association between pre-donation zinc protoporphyrin levels and post-transfusion recovery

  5. ferritin (donation 1) [ Time Frame: Day 0 ]
    Will be an association between pre-donation zinc protoporphyrin levels and other markers of iron status

  6. ferritin (donation 2) [ Time Frame: 5 months and 42 days - prior to second blood donation ]
    Will be an association between pre-donation zinc protoporphyrin levels and other markers of iron status

  7. ferritin (PTR 1) [ Time Frame: 42 days - after first blood donation ]
    Will be an association between pre-donation zinc protoporphyrin levels and other markers of iron status

  8. ferritin (PTR 2) [ Time Frame: 5 months and 84 days - prior to second post-transfusion recovery study ]
    Will be an association between pre-donation zinc protoporphyrin levels and other markers of iron status

  9. soluble transferrin receptor (donation 1) [ Time Frame: Day 0 ]
    Will be an association between pre-donation zinc protoporphyrin levels and other markers of iron status

  10. soluble transferrin receptor (donation 2) [ Time Frame: 5 months and 42 days - prior to second blood donation ]
    Will be an association between pre-donation zinc protoporphyrin levels and other markers of iron status

  11. soluble transferrin receptor (PTR 1) [ Time Frame: 42 days - after first blood donation ]
    Will be an association between pre-donation zinc protoporphyrin levels and other markers of iron status

  12. soluble transferrin receptor (PTR 2) [ Time Frame: 5 months and 84 days - prior to second post-transfusion recovery study ]
    Will be an association between pre-donation zinc protoporphyrin levels and other markers of iron status

  13. hepcidin (donation 1) [ Time Frame: Day 0 ]
    Will be an association between pre-donation zinc protoporphyrin levels and other markers of iron status

  14. hepcidin (donation 2) [ Time Frame: 5 months and 42 days - prior to second blood donation ]
    Will be an association between pre-donation zinc protoporphyrin levels and other markers of iron status

  15. hepcidin (PTR 1) [ Time Frame: 42 days - after first blood donation ]
    Will be an association between pre-donation zinc protoporphyrin levels and other markers of iron status

  16. hepcidin (PTR 2) [ Time Frame: 5 months and 84 days - prior to second post-transfusion recovery study ]
    Will be an association between pre-donation zinc protoporphyrin levels and other markers of iron status

  17. SF-36 overall health status and quality of life Score (donation 1) [ Time Frame: Day 0 ]
    Evaluating individual patients health status using Short Form (SF) survey.

  18. SF-36 overall health status and quality of life Score (donation 2) [ Time Frame: 5 months and 42 days - prior to second blood donation ]
    Evaluating individual patients health status.

  19. SF-36 overall health status and quality of life Score (PTR 1) [ Time Frame: 42 days - after first blood donation ]
    Evaluating individual patients health status.

  20. SF-36 overall health status and quality of life Score (PTR 2) [ Time Frame: 5 months and 84 days - prior to second post-transfusion recovery study ]
    Evaluating individual patients health status.

  21. Multidimensional Assessment of Fatigue Score (donation 1) [ Time Frame: Day 0 ]
    Evaluating fatigue and the effect of fatigue on patient activities.

  22. Multidimensional Assessment of Fatigue Score (donation 2) [ Time Frame: 5 months and 42 days - prior to second blood donation ]
    Evaluating fatigue and the effect of fatigue on patient activities.

  23. Multidimensional Assessment of Fatigue Score (PTR 1) [ Time Frame: 42 days - after first blood donation ]
    Evaluating fatigue and the effect of fatigue on patient activities.

  24. Multidimensional Assessment of Fatigue Score (PTR 2) [ Time Frame: 5 months and 84 days - prior to second post-transfusion recovery study ]
    Evaluating fatigue and the effect of fatigue on patient activities.

  25. Beck Depression Inventory-II Score (donation 1) [ Time Frame: Day 0 ]
    Measuring the severity of depression.

  26. Beck Depression Inventory-II Score (donation 2) [ Time Frame: 5 months and 42 days - prior to second blood donation ]
    Measuring the severity of depression.

  27. Beck Depression Inventory-II Score (PTR 1) [ Time Frame: 42 days - after first blood donation ]
    Measuring the severity of depression.

  28. Beck Depression Inventory-II Score (PTR 2) [ Time Frame: 5 months and 84 days - prior to second post-transfusion recovery study ]
    Measuring the severity of depression.

  29. Beck Anxiety Inventory Score (donation 1) [ Time Frame: Day 0 ]
    Measuring the severity of anxiety.

  30. Beck Anxiety Inventory Score (donation 2) [ Time Frame: 5 months and 42 days - prior to second blood donation ]
    Measuring the severity of anxiety.

  31. Beck Anxiety Inventory Score (PTR 1) [ Time Frame: 42 days - after first blood donation ]
    Measuring the severity of anxiety.

  32. Beck Anxiety Inventory Score (PTR 2) [ Time Frame: 5 months and 84 days - prior to second post-transfusion recovery study ]
    Measuring the severity of anxiety.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02889133


Locations
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United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
New York Blood Center
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Eldad Hod, MD Associate Professor of Pathology and Cell Biology, Dept of Pathology&Cell Biology

Publications:
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Responsible Party: Eldad Arie Hod, Associate Professor of Pathology and Cell Biology, Dept of Pathology&Cell Biology, Columbia University
ClinicalTrials.gov Identifier: NCT02889133     History of Changes
Other Study ID Numbers: AAAQ8875
1R01HL133049-01 ( U.S. NIH Grant/Contract )
First Posted: September 5, 2016    Key Record Dates
Last Update Posted: February 4, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Eldad Arie Hod, Columbia University:
Iron deficiency
Transfusion
Blood donation

Additional relevant MeSH terms:
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Anemia, Iron-Deficiency
Anemia, Hypochromic
Anemia
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases
Iron
Dextrans
Iron-Dextran Complex
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Anticoagulants
Plasma Substitutes
Blood Substitutes
Hematinics