IV Iron for the Anemia of Traumatic Critical Illness

Completed · Not applicable · Has a placebo group

Conditions studied: Trauma, ICU Anemia

In brief

The purpose of this clinical trial is to determine whether intravenous iron supplementation of anemic, critically ill trauma patients improves anemia and reduces the need for a red blood cell transfusion.

Key facts

Study ID

NCT01180894

Run by

Denver Health and Hospital Authority

People needed

150

Starts

2011-06-01

Expected to finish

2013-09-01

Last updated by the study team

2018-02-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ICU admission for trauma
• Adults (age ≥ 18 years)
• Anemia (hemoglobin < 12 g/dL)
• ≤ 72 hours from ICU admission
• Expected ICU length of stay ≥ 7 days

You may not qualify if…

• Active hemorrhage requiring RBC transfusion
• Iron overload (serum ferritin concentration ≥ 1,000 ng/mL) or any condition associated with iron overload (e.g., hemochromatosis, aceruloplasminemia
• Chronic inflammatory conditions (e.g., systemic lupus erythematosis, rheumatoid arthritis, ankylosing spondilitis)
• Pre-existing hematologic disorders (e.g., thalassemia, sickle cell disease, hemophilia, von Willibrand's disease, myeloproliferative disease)
• Macrocytic anemia (mean corpuscular volume ≥ 100 fL)
• Current use of immunosuppressive agents including corticosteroids (e.g., dexamethasone, hydrocortisone, methylprednisolone, prednisone, exclusive of inhaled corticosteroids), calcinurin inhibitors (e.g., cyclosporine, tacrolimus), antimetabolites (e.g., azathioprine), or biologics (e.g., OKT3, thymoglobulin)
• Use of recombinant human erythropoietin formulation within the prev 30 days
• Pregnancy or lactation
• Prohibition of RBC transfusion
• Stay of ≥ 48 hours duration in the ICU of a transferring hospital
• History of intolerance or hypersensitivity to either enteral or intravenous iron
• Moribund state in which death is imminent
• Enrollment in any other clinical trial

Where it is running

• Johns Hopkins Hospital — Baltimore, Maryland, United States
• University of Michigan Health Systems — Ann Arbor, Michigan, United States
• NewYork Presbyterian Medical Center/Weill Cornell Medical College — New York, New York, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
• Harborview Medical Center/University of Washington — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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