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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01180894
Recruitment Status : Completed
First Posted : August 12, 2010
Results First Posted : January 20, 2017
Last Update Posted : February 5, 2018
National Trauma Research Institute
Information provided by (Responsible Party):
Fredric Pieracci, Denver Health and Hospital Authority

August 11, 2010
August 12, 2010
September 16, 2015
January 20, 2017
February 5, 2018
June 2011
September 2013   (Final data collection date for primary outcome measure)
RBC Transfusion [ Time Frame: 42 Days ]
The number of participants who underwent RBC transfusion.
Complete list of historical versions of study NCT01180894 on Archive Site
  • Iron-deficient Erythropoeisis (IDE) [ Time Frame: 14 Days ]
    An elevated eZPP is diagnostic of Iron-deficient erythropoiesis (IDE) and reflects the bone marrow iron supply regardless of total body iron.
  • Infection [ Time Frame: 28 Days ]

    The number of participants with at least one infection.

    Specific infections analyzed included VAP (Ventilator-Associated Pneumonia), bacteremia, and urinary tract infection (UTI).

  • The Number of Participants Who Died [ Time Frame: 28 Days ]
  • Iron-deficient erythropoeisis
  • Red blood cell transfusion
  • Infection
  • Mortality
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.

Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Trauma
  • ICU Anemia
  • Drug: Iron sucrose
    100 mg IV TIW
    Other Name: Fe sucrose
  • Drug: Placebo
    Other Name: control
  • Active Comparator: Iron sucrose
    100 mg IV TIW
    Intervention: Drug: Iron sucrose
  • Placebo Comparator: Placebo
    Pacebo - Normal Saline
    Intervention: Drug: Placebo
Pieracci FM, Stovall RT, Jaouen B, Rodil M, Cappa A, Burlew CC, Holena DN, Maier R, Berry S, Jurkovich J, Moore EE. A multicenter, randomized clinical trial of IV iron supplementation for anemia of traumatic critical illness*. Crit Care Med. 2014 Sep;42(9):2048-57. doi: 10.1097/CCM.0000000000000408.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Plan to Share IPD: No
Fredric Pieracci, Denver Health and Hospital Authority
Denver Health and Hospital Authority
National Trauma Research Institute
Principal Investigator: Fredric M Pieracci, MD, MPH Denver Health Medical Center, University of Colorado Health Science Center
Denver Health and Hospital Authority
January 2018

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