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

NCT02889133 | Completed Results DMC

• 2 other identifiers: AAAQ88751R01HL133049-01
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

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.

Conditions

Iron Deficiency

Keywords

Iron deficiency; Transfusion; Blood donation

Outcome Measures

Primary Outcomes (1)

• 51-Chromium 24-hour Post-transfusion RBC Recovery of Units

  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.

  Performed 42 days after blood donation

Secondary Outcomes (20)

• RBC Zinc Protoporphyrin Levels

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

• Serum Ferritin

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

• Hemoglobin

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

• Reticulocyte Hemoglobin

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

• Soluble Transferrin Receptor

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

Study Arms (2)

Iron repletion

ACTIVE COMPARATOR

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; Drug: Saline; Procedure: Blood Donation; Procedure: 24-hour PTR

Placebo

PLACEBO COMPARATOR

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; Drug: Saline; Procedure: Blood Donation; Procedure: 24-hour PTR

Interventions

Iron-dextran DRUG

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

Also known as: INFeD, Low molecular weight iron-dextran

Iron repletion; Placebo

Saline DRUG

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

Also known as: Placebo, Normal Saline

Iron repletion; Placebo

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.

Also known as: Red blood cell donation

Iron repletion; Placebo

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.

Also known as: 24-hour post-transfusion red cell recovery

Iron repletion; Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Columbia University: lead
• New York Blood Center: collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

Related Publications (3)

• 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.

  PMID: 6710582 BACKGROUND

• 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.

  PMID: 36069596 DERIVED

• 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.

  PMID: 33657208 DERIVED

MeSH Terms

Conditions

Iron Deficiencies

Interventions

Iron-Dextran Complex; Sodium Chloride; Saline Solution; Blood Donation

Condition Hierarchy (Ancestors)

Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Dextrans; Glucans; Polysaccharides; Carbohydrates; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Tissue and Organ Procurement; Health Services; Health Care Facilities Workforce and Services

Results Point of Contact

• Title: Dr. Eldad Hod
• Organization: Columbia University Medical Center

eh2217@cumc.columbia.edu

212-305-4109

Study Officials

• Eldad A. Hod, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Pathology and Cell Biology, Dept of Pathology&Cell Biology

Study Record Dates

• First Submitted: August 25, 2016
• First Posted: September 5, 2016
• Study Start: January 1, 2017
• Primary Completion: October 5, 2021
• Study Completion: October 5, 2021
• Last Updated: June 12, 2024
• Results First Posted: June 12, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)