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A Multicenter, Randomized Clinical Trial of IV Iron Supplementation for Anemia of Traumatic Critical Illness*

Pieracci, Fredric M. MD, MPH; Stovall, Robert T. MD; Jaouen, Brant BA; Rodil, Maria BA; Cappa, Anthony MD; Burlew, Clay Cothren MD; Holena, Daniel N. MD; Maier, Ronald MD; Berry, Stepheny MD; Jurkovich, Jerry MD; Moore, Ernest E. MD

doi: 10.1097/CCM.0000000000000408
Clinical Investigations

Objective: To evaluate the efficacy of IV iron supplementation of anemic, critically ill trauma patients.

Design: Multicenter, randomized, single-blind, placebo-controlled trial.

Setting: Four trauma ICUs.

Patients: Anemic (hemoglobin < 12 g/dL) trauma patients enrolled within 72 hours of ICU admission and with an expected ICU length of stay of more than or equal to 5 days.

Interventions: Randomization to iron sucrose 100 mg IV or placebo thrice weekly for up to 2 weeks.

Measurements and Main Results: A total of 150 patients were enrolled. Baseline iron markers were consistent with functional iron deficiency: 134 patients (89.3%) were hypoferremic, 51 (34.0%) were hyperferritinemic, and 64 (42.7%) demonstrated iron-deficient erythropoiesis as evidenced by an elevated erythrocyte zinc protoporphyrin concentration. The median baseline transferrin saturation was 8% (range, 2–58%). In the subgroup of patients who received all six doses of study drug (n = 57), the serum ferritin concentration increased significantly for the iron as compared with placebo group on both day 7 (808.0 ng/mL vs 457.0 ng/mL, respectively, p < 0.01) and day 14 (1,046.0 ng/mL vs 551.5 ng/mL, respectively, p < 0.01). There was no significant difference between groups in transferrin saturation, erythrocyte zinc protoporphyrin concentration, hemoglobin concentration, or packed RBC transfusion requirement. There was no significant difference between groups in the risk of infection, length of stay, or mortality.

Conclusions: Iron supplementation increased the serum ferritin concentration significantly, but it had no discernible effect on transferrin saturation, iron-deficient erythropoiesis, hemoglobin concentration, or packed RBC transfusion requirement. Based on these data, routine IV iron supplementation of anemic, critically ill trauma patients cannot be recommended (NCT 01180894).

1Department of Surgery, Denver Health Medical Center/University of Colorado School of Medicine, Denver, CO.

2Department of Surgery, University of Pennsylvania School of Medicine, Philadelphia, PA.

3Department of Surgery, Harborview Medical Center/University of Washington School of Medicine, Seattle, WA.

4Department of Surgery, University of Kansas Medical Center, Kansas City, KS.

* See also p. 2140.

Supported, in part, by grant NTI-ICU-008-01 from the National Trauma Institute and by Prime Award 08302001 from the Department of the Army.

Dr. Pieracci received support for article research from the National Trauma Institute (NTI)/Department of Defense. His institution received grant support from NTI (funding source). Dr. Stovall, Mr. Jaouen, Ms. Rodil, Dr. Cappa, Dr. Burlew, Dr. Holena, Dr. Maier, Dr. Berry, Dr. Jurkovich, and Dr. Moore received support for article research from the NTI. The U.S. Army Medical Research Acquisition Activity, 820 Chandler Street, Fort Detrick, MD 21702–5014, is the awarding and administering acquisition office. The opinions or assertions contained herein are the private views of the authors and are not to be construed as official or as reflecting the views of the Department of the Army of the Department of Defense.

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