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IV Iron for the Anemia of Traumatic Critical Illness (IATCI)

This study has been completed.
Sponsor:
Collaborator:
National Trauma Institute
Information provided by (Responsible Party):
Fredric Pieracci, Denver Health and Hospital Authority
ClinicalTrials.gov Identifier:
NCT01180894
First received: August 11, 2010
Last updated: December 2, 2013
Last verified: December 2013

August 11, 2010
December 2, 2013
June 2011
September 2013   (final data collection date for primary outcome measure)
Anemia [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01180894 on ClinicalTrials.gov Archive Site
  • Iron-deficient erythropoeisis [ Designated as safety issue: No ]
  • Red blood cell transfusion [ Designated as safety issue: No ]
  • Infection [ Designated as safety issue: Yes ]
  • Mortality [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
IV Iron for the Anemia of Traumatic Critical Illness
A Multicenter, Randomized, Double-blind Comparison of Intravenous Iron Supplementation to Placebo for the Treatment of Anemia of Traumatic Critical Illness

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.

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 healing, and death. Current therapies for ICU anemia are unsatisfactory: Red blood cell (RBC) transfusion is associated with an increased risk of immune suppression, infection, and organ failure. Furthermore, use of both hemoglobin replacement products and erythropoietin are limited by expense as well as unfavorable side effect profiles.

One principal cause of anemia in trauma ICU patients involves disturbances in iron metabolism. Iron is necessary to make RBCs, and a lack of iron delivered to the bone marrow results in anemia. Trauma causes diversion of iron from the bone marrow into storage, where it cannot participate in the generation of RBCs. This diversion of iron is caused by inflammatory proteins released as a result of tissue injury.

Previous work by the principal investigator among ICU patients suggested a benefit to oral iron supplementation administered in dosages similar to those used in a standard multivitamin. However, many patients were not able to tolerate oral medications, and this study was not specific to trauma patients. Additional research has suggested that intravenous iron supplementation is effective in treating anemic patients with other inflammatory conditions, such as cancer and inflammatory bowel disease. However, the benefit of intravenous iron supplementation has never been tested among anemic ICU patients, including trauma patients.

The current clinical trial will evaluate the risk/benefit profile of intravenous iron supplementation among anemic trauma ICU patients. The study will take place over several academic trauma centers with a long history of participation in translational research.

Anemia remains a devastating complication of trauma. Current treatment options are limited. Intravenous iron supplementation represents a targeted, cost-effective solution to this pervasive problem, the efficacy of which remains undefined.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Trauma
  • ICU Anemia
  • Drug: Iron sucrose
    100 mg IV TIW
  • Drug: Placebo
  • Active Comparator: Iron sucrose
    100 mg IV TIW
    Intervention: Drug: Iron sucrose
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
150
September 2013
September 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01180894
10-0705
Yes
Fredric Pieracci, Denver Health and Hospital Authority
Denver Health and Hospital Authority
National Trauma Institute
Principal Investigator: Fredric M Pieracci, MD, MPH Denver Health Medical Center, University of Colorado Health Science Center
Denver Health and Hospital Authority
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP