IV Iron for the Anemia of Traumatic Critical Illness

• Status: Completed
• Trial end date: 2013-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Denver Health and Hospital Authority
• Collaborators: National Trauma Institute; National Trauma Research Institute
• Treatments: Ferric Oxide, Saccharated; Iron

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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