Back to Transplant Trial Watch

A randomized trial of blood donor iron repletion on red cell quality for transfusion and donor cognition and wellbeing

Columbia University Medical Center, New York, New York, United States. Columbia University College of Physicians and Surgeons, New York, New York, United States. Columbia University Irving Medical Center, New York, New York, United States. Columbia University Medical Center, New York, Maryland, United States. Columbia University Medical Center, Paramus, New Jersey, United States. Mount Sinai Health System, Tenafly, New Jersey, United States. New York Blood Center, New York, New York, United States. New York Blood Center, United States. Columbia University, New York, New York, United States.

Blood. 2022
Full text from:

Other resources

PICO Summary

Population

Adult iron-deficient blood donors enrolled in the Donor Iron Deficiency Study (DIDS), (n= 79).

Intervention

Intravenous iron repletion (n= 39).

Comparison

Placebo (n= 40).

Outcome

A first standard blood donation was followed by the gold-standard measure for red cell storage quality: a 51-chromium post-transfusion red cell recovery study. Donors were then randomized. A second donation approximately five months later was followed by another recovery study. Primary outcome was the within-subject change in post-transfusion recovery. The primary outcome measure was the National Institutes of Health (NIH) Toolbox-derived uncorrected standard Cognition Fluid Composite Score. Overall, 983 donors were screened; 110 were iron-deficient and, of these, 39 were randomized to iron repletion and 40 to placebo. Red cell storage quality was unchanged by iron repletion: mean change in post-transfusion recovery was 1.6% (95% CI -0.5 - 3.8) and -0.4% (-2.0 - 1.2) with and without iron, respectively. Iron repletion did not affect any cognition or wellbeing measures.
Abstract
Although altruistic regular blood donors are vital for the blood supply, many become iron deficient from donation-induced iron loss. The effects of blood donation-induced iron deficiency on red cell transfusion quality or donor cognition are unknown. In this double-blind, randomized trial, adult iron-deficient blood donors (n=79; ferritin <15 mg/L, and zinc protoporphyrin >60 mMol/mol heme) who met donation qualifications were enrolled. A first standard blood donation was followed by the gold-standard measure for red cell storage quality: a 51-chromium post-transfusion red cell recovery study. Donors were then randomized to intravenous iron repletion (one-gram low molecular weight iron dextran) or placebo. A second donation approximately five months later was followed by another recovery study. Primary outcome was the within-subject change in post-transfusion recovery. The primary outcome measure of an ancillary study reported here was the National Institutes of Health (NIH) Toolbox-derived uncorrected standard Cognition Fluid Composite Score. Overall, 983 donors were screened; 110 were iron-deficient and, of these, 39 were randomized to iron repletion and 40 to placebo. Red cell storage quality was unchanged by iron repletion: mean change in post-transfusion recovery was 1.6% (95% CI -0.5 - 3.8) and -0.4% (-2.0 - 1.2) with and without iron, respectively. Iron repletion did not affect any cognition or wellbeing measures. These data provide evidence that current criteria for blood donation preserve red cell transfusion quality for the recipient and protect adult donors from measurable effects of blood donation-induced iron deficiency on cognition. This trial was registered at www.clinicaltrials.gov as NCT02889133 and NCT02990559.
Study details
Language : eng
Credits : Bibliographic data from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine