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

Primary Purpose

Iron Deficiency

Status

Active

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Iron-dextran

Saline

Blood Donation

24-hour PTR

About this trial

This is an interventional basic science trial for Iron Deficiency focused on measuring Iron deficiency, Transfusion, Blood donation

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Columbia University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Iron repletion

Placebo

Arm 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.

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.

Outcomes

Primary Outcome Measures

51-Chromium 24-hour post-transfusion RBC recovery of units

Secondary Outcome Measures

RBC zinc protoporphyrin levels

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.

Serum ferritin

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.

Hemoglobin

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.

Reticulocyte Hemoglobin

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.

Soluble transferrin receptor

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.

Hepcidin

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.

Transferrin saturation

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.

SF-36 Physical functioning score

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

SF-36 Role functioning/physical score

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

SF-36 Role functioning/emotional score

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

SF-36 Energy/fatigue score

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

SF-36 Emotional well-being score

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

SF-36 Social functioning score

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

SF-36 Pain score

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

SF-36 General health score

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

SF-36 Health change score

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

Beck Depression Inventory (BDI) II score

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

Beck Anxiety Inventory (BAI) score

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

Global Fatigue Index (GFI) score

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

Restless Legs Syndrome Rating Scale score

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.

Full Information

NCT ID

NCT02889133

First Posted

August 25, 2016

Last Updated

February 14, 2022

Sponsor

Columbia University

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT02889133

Brief Title

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

Acronym

DIDS

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2022

Overall Recruitment Status

Active, not recruiting

Study Start Date

January 2017 (Actual)

Primary Completion Date

July 2022 (Anticipated)

Study Completion Date

July 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Columbia University

Collaborators

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

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Iron Deficiency

Keywords

Iron deficiency, Transfusion, Blood donation

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

85 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Iron repletion

Arm Type

Active Comparator

Arm 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.

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm 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.

Intervention Type

Drug

Intervention Name(s)

Iron-dextran

Other Intervention Name(s)

INFeD, Low molecular weight iron-dextran

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Saline

Other Intervention Name(s)

Placebo, Normal Saline

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Blood Donation

Other Intervention Name(s)

Red blood cell donation

Intervention Description

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.

Intervention Type

Procedure

Intervention Name(s)

24-hour PTR

Other Intervention Name(s)

24-hour post-transfusion red cell recovery

Intervention Description

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.

Primary Outcome Measure Information:

Title

51-Chromium 24-hour post-transfusion RBC recovery of units

Time Frame

Performed 42 days after blood donation

Secondary Outcome Measure Information:

Title

RBC zinc protoporphyrin levels

Description

Time Frame