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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 : March 27, 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 [ Time Frame: Day 0-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: Day 0-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: Day 0-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: Day 0-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: Day 0-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: Day 0-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: Day 0-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: Day 0-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: Day 0-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: Day 0-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: Day 0-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: Day 0-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: Day 0-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: Day 0-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: Day 0-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: Day 0-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: Day 0-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: Day 0-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: Day 0-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: Day 0-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.



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: March 27, 2019
Last Verified: March 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