Transfusion Evidence Library

1. High-dose intravenous versus oral iron in blood donors with iron deficiency: The IronWoMan randomized, controlled clinical trial

Drexler C, Macher S, Lindenau I, Holter M, Moritz M, Stojakovic T, Pieber TR, Schlenke P, Amrein K

Clinical nutrition (Edinburgh, Scotland). 2019

Abstract

INTRODUCTION Frequent blood donation often leads to iron deficiency and even anemia but appropriate strategies for detection and prevention are currently not mandatory. At the Medical University of Graz, we conducted a single-center prospective clinical trial to compare oral and IV iron supplementation in iron deficient blood donors including Austrian regular whole blood and platelet apheresis donors. We aimed to determine the difference of transferrin saturation between the treatment groups 8-12 weeks iron administration besides other parameters of iron status and blood count. METHODS 176 healthy male and female blood donors with iron deficiency (ferritin ≤30 ng/mL) were randomized to either a single dose of IV ferric carboxymaltose (1000 mg, n = 86) or oral iron (II)fumarate (100 tablets of 100 mg [10 per week], n = 90). RESULTS Between 2014 and 2016, 172 donors (137 women) completed the study; 4 in the oral group were lost to follow-up. At follow-up, median (IQR) transferrin saturation and ferritin were significantly higher in the intravenous group (27 [23-35]%, vs 21.0 [16-32]%; p < 0.001 and 105 [75-145] ng/mL vs 25 [17-34] ng/mL; p < 0.001, respectively) while median (IQR) hemoglobin levels were comparable (IV, 13.6 [13.0-14.4] g/dL vs oral, 13.6 [13.0-14.2] g/dL). The frequency of adverse effects was comparable (38% in both groups) and no serious adverse events occurred. CONCLUSIONS A single dose of 1000 mg of intravenous iron is highly effective to counteract iatrogenic iron deficiency in blood donors. Oral iron appears to be an acceptable alternative. The assessment of body iron stores should play a key role in maintaining blood donors' health. This trial was registered at www.clinicaltrials.gov as NCT01787526 on February 8, 2013 and at www.clinicaltrialsregister.eu (EudraCT identifier: 2013-000327-14) on September 24, 2013.

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2. The impact of intensive serial plasmapheresis and iron supplementation on iron metabolism and Hb concentration in menstruating women: a prospective randomized placebo-controlled double-blind study

Bier-Ulrich AM, Haubelt H, Anders C, Nagel D, Schneider S, Siegler KE, Seiler D, Hellstern P

Transfusion. 2003;43((3):):405-410.

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3. The efficacy of subcutaneous recombinant human erythropoietin in the correction of phlebotomy-induced anemia in autologous blood donors

Biesma DH, Kraaijenhagen RJ, Marx JJ, Van De Wiel A

Transfusion. 1993;33((10):):825-829.

Wiley

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4. Epoetin enhances erythropoiesis in normal men undergoing repeated phlebotomies

Abraham PA, Halstenson CE, Macres MM, Opsahl JA, Rank BH, Schwenk MH, Lasky LC, Cohen A, Lasseter KC, Smith DL,, et al

Clinical Pharmacology & Therapeutics. 1992;52((2):):205-13.

Abstract

Epoetin may enhance autologous blood donation, but efficacy and dose response have not been established. This multicenter, double-blind trial compared intravenous placebo (n = 23) with epoetin beta, 250 U/kg (n = 23), 500 U/kg (n = 19), and 1000 U/kg (n = 22), administered three times weekly for 26 days. Normal men (age, 28 +/- 7 years; mean +/- SD) received phlebotomies up to three times weekly as long as the hemoglobin remained greater than or equal to 12 gm/dl. Subjects treated with epoetin donated 32% more units of blood (p less than 0.05) compared with placebo. A dose response was not observed. Platelet counts increased with epoetin compared with placebo, but platelet function and bleeding time did not change. Prothrombin times increased and partial thromboplastin times decreased with both epoetin and placebo. The supernatant of packed red blood cells collected after multiple phlebotomies and stored 42 days had slightly lower glucose concentrations and pH after therapy with epoetin. Blood pressure did not change with epoetin or placebo. These findings support the efficacy and safety of epoetin for enhancing the erythropoietic response of normal subjects during intensive phlebotomy.

Wiley

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5. Iron supplementation in female blood donors deferred by copper sulfate screening

Cable RG, Morse EE, Keltonic J, Kakaiya R, Kiraly T

Transfusion. 1988;28((5):):422-6.

Abstract

Female blood donors with low hematocrit levels detected by copper sulfate screening were selected randomly to receive either 75 mg of iron per day, as ferrous gluconate, or a calcium phosphate placebo. Their ferritin, serum iron, total iron-binding capacity, zinc protoporphyrin, and hemoglobin values, as well as their suitability to donate blood, were determined initially (Visit 1) and at four follow-up visits (Visits 2-5). By the second visit, the serum ferritin and iron values of donors receiving iron supplementation differed significantly from those of donors receiving placebo. By the fifth visit, a less marked but significant increase in hemoglobin had occurred in the iron group, but not in the placebo group. At no time was there a significant difference between the groups' suitability to donate blood, with each group donating at almost half of their visits. The authors conclude that iron supplementation at this dose level in deferred female blood donors improves their iron status and hemoglobin levels, but does not significantly increase their suitability to donate blood as compared with the suitability of placebo-treated donors.

Wiley

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6. Carbonyl iron for short-term supplementation in female blood donors

Gordeuk VR, Brittenham GM, Hughes MA, Keating LJ

Transfusion. 1987;27((1):):80-5.

Abstract

A randomized, double-blind trial of iron replacement after repeated blood donation was conducted in 75 menstruating women; 51 completed the study. Volunteers were assigned randomly to one of three treatment groups: 1) carbonyl iron (nontoxic elemental iron powder), 600 mg; 2) ferrous sulfate, 300 mg (60 mg Fe++); or 3) placebo, each given three times daily for 1 week immediately after blood donation. Blood samples obtained initially and 56 days later were tested for hemoglobin, mean corpuscular volume (MCV), free erythrocyte protoporphyrin, serum ferritin, serum iron, total iron binding capacity (TIBC), and percent saturation of TIBC. The prevalence of gastrointestinal side effects was similar in both groups taking iron. At the end of the study there was no laboratory evidence of change in iron status in women who received carbonyl iron (n = 15). In those treated with ferrous sulfate (n = 17) the mean TIBC increased (p less than 0.001), and in the placebo group (n = 19) there were decreases in mean MCV (p less than 0.01), serum ferritin (p less than 0.001), and percent saturation (p = 0.027) with an increase in mean TIBC (p = 0.004). Carbonyl iron seems to be effective for short-term iron replacement in repeat blood donors and may have the advantage of decreased or absent risk of poisoning if accidentally ingested by children.

Wiley

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7. Iron supplementation for menstruating female blood donors

Simon TL, Hunt WC, Garry PJ

Transfusion. 1984;24((6):):469-72.

Abstract

Depletion of body iron stores is a major factor limiting regular blood donations by menstruating females. To determine if regular iron supplementation would solve this problem, we conducted a double-blind study in which menstruating female donors were randomly placed into one of three groups: one taking 39 mg elemental iron, a second taking 39 mg of iron plus 75 mg vitamin C, and a third taking 100 mg vitamin C daily. The women were requested to donate every 8 weeks for at least 1 year. Blood samples were taken on each donation for measurements of hemoglobin, total iron binding capacity (TIBC), and ferritin. In the two groups taking iron supplements hemoglobin and ferritin increased from baseline values and the TIBC decreased. The vitamin C control group showed decreases from baseline for hemoglobin and ferritin and increases in TIBC. Differences between groups taking iron supplements and the group not taking supplements were highly significant. Drop-out from the study was due to various causes; however, iron intolerance was uncommon. Minimal daily iron supplementation was beneficial in maintaining body iron stores and hemoglobin levels in menstruating females on a schedule of blood donation as often as every 8 weeks.