Status:
COMPLETED
IV Iron for the Anemia of Traumatic Critical Illness
Lead Sponsor:
Denver Health and Hospital Authority
Collaborating Sponsors:
National Trauma Research Institute
Conditions:
Trauma
ICU Anemia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 transfus...
Detailed Description
Nearly all trauma patients admitted to an intensive care unit (ICU) are anemic (low red blood cell counts). Anemia is an independent risk factor for poor outcomes, including infection, impaired wound ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2013
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT01180894
Start Date
June 1 2011
End Date
September 1 2013
Last Update
February 5 2018
Active Locations (6)
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1
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
2
University of Michigan Health Systems
Ann Arbor, Michigan, United States, 48103
3
NewYork Presbyterian Medical Center/Weill Cornell Medical College
New York, New York, United States, 10065
4
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19102