- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02889133
Donor Iron Deficiency Study - Red Blood Cells From Iron-deficient Donors: Recovery and Storage Quality (DIDS)
February 14, 2022 updated by: Eldad Arie Hod, Columbia University
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
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
85
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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New York
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New York, New York, United States, 10032
- Columbia University Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / 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.
|
Approved for clinical use: 1-gram dose IV - diluted in 500 mL, one pint normal saline.
Other Names:
Salt water IV - 500 mL, one pint normal saline.
Other Names:
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:
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:
|
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.
|
Approved for clinical use: 1-gram dose IV - diluted in 500 mL, one pint normal saline.
Other Names:
Salt water IV - 500 mL, one pint normal saline.
Other Names:
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:
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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
51-Chromium 24-hour post-transfusion RBC recovery of units
Time Frame: Performed 42 days after blood donation
|
Performed 42 days after blood donation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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Day 0-end of participation (e.g., ~6 months)
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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.
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Day 0-end of participation (e.g., ~6 months)
|
Hemoglobin
Time Frame: Day 0-end of participation (e.g., ~6 months)
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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.
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Day 0-end of participation (e.g., ~6 months)
|
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.
|
Day 0-end of participation (e.g., ~6 months)
|
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.
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Day 0-end of participation (e.g., ~6 months)
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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.
|
Day 0-end of participation (e.g., ~6 months)
|
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.
|
Day 0-end of participation (e.g., ~6 months)
|
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.
|
Day 0-end of participation (e.g., ~6 months)
|
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.
|
Day 0-end of participation (e.g., ~6 months)
|
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.
|
Day 0-end of participation (e.g., ~6 months)
|
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.
|
Day 0-end of participation (e.g., ~6 months)
|
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.
|
Day 0-end of participation (e.g., ~6 months)
|
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.
|
Day 0-end of participation (e.g., ~6 months)
|
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.
|
Day 0-end of participation (e.g., ~6 months)
|
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.
|
Day 0-end of participation (e.g., ~6 months)
|
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.
|
Day 0-end of participation (e.g., ~6 months)
|
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.
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Day 0-end of participation (e.g., ~6 months)
|
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.
|
Day 0-end of participation (e.g., ~6 months)
|
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.
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Day 0-end of participation (e.g., ~6 months)
|
Restless Legs Syndrome Rating Scale score
Time Frame: Day 0-end of participation (e.g., ~6 months)
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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.
|
Day 0-end of participation (e.g., ~6 months)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Eldad Hod, MD, Associate Professor of Pathology and Cell Biology, Dept of Pathology&Cell Biology
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Moroff G, Sohmer PR, Button LN. Proposed standardization of methods for determining the 24-hour survival of stored red cells. Transfusion. 1984 Mar-Apr;24(2):109-14. doi: 10.1046/j.1537-2995.1984.24284173339.x.
- Hod EA, Brittenham GM, Bitan ZC, Feit Y, Gaelen JI, La Carpia F, Sandoval LA, Zhou AT, Soffing M, Mintz A, Schwartz J, Eng C, Scotto M, Caccappolo E, Habeck C, Stern Y, McMahon DJ, Kessler DA, Shaz BH, Francis RO, Spitalnik SL. A randomized trial of blood donor iron repletion on red cell quality for transfusion and donor cognition and well-being. Blood. 2022 Dec 22;140(25):2730-2739. doi: 10.1182/blood.2022017288.
- Roussel C, Morel A, Dussiot M, Marin M, Colard M, Fricot-Monsinjon A, Martinez A, Chambrion C, Henry B, Casimir M, Volle G, Depond M, Dokmak S, Paye F, Sauvanet A, Le Van Kim C, Colin Y, Georgeault S, Roingeard P, Spitalnik SL, Ndour PA, Hermine O, Hod EA, Buffet PA, Amireault P. Rapid clearance of storage-induced microerythrocytes alters transfusion recovery. Blood. 2021 Apr 29;137(17):2285-2298. doi: 10.1182/blood.2020008563.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2017
Primary Completion (Anticipated)
July 1, 2022
Study Completion (Anticipated)
July 1, 2022
Study Registration Dates
First Submitted
August 25, 2016
First Submitted That Met QC Criteria
August 30, 2016
First Posted (Estimate)
September 5, 2016
Study Record Updates
Last Update Posted (Actual)
February 15, 2022
Last Update Submitted That Met QC Criteria
February 14, 2022
Last Verified
February 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AAAQ8875
- 1R01HL133049-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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