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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01180894
First Posted: August 12, 2010
Last Update Posted: January 20, 2017
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.
Collaborator:
National Trauma Research Institute
Information provided by (Responsible Party):
Fredric Pieracci, Denver Health and Hospital Authority
  Purpose
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.

Condition Intervention
Trauma ICU Anemia Drug: Iron sucrose Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-blind Comparison of Intravenous Iron Supplementation to Placebo for the Treatment of Anemia of Traumatic Critical Illness

Resource links provided by NLM:


Further study details as provided by Fredric Pieracci, Denver Health and Hospital Authority:

Primary Outcome Measures:
  • RBC Transfusion [ Time Frame: 42 Days ]
    The number of participants who underwent RBC transfusion.


Secondary Outcome Measures:
  • 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 ]

Enrollment: 150
Study Start Date: June 2011
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Iron sucrose
100 mg IV TIW
Drug: Iron sucrose
100 mg IV TIW
Placebo Comparator: Placebo
Pacebo - Normal Saline
Drug: Placebo

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 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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01180894


Locations
United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
United States, Michigan
University of Michigan Health Systems
Ann Arbor, Michigan, United States, 48103
United States, New York
NewYork Presbyterian Medical Center/Weill Cornell Medical College
New York, New York, United States, 10065
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19102
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15201
United States, Washington
Harborview Medical Center/University of Washington
Seattle, Washington, United States, 98102
Sponsors and Collaborators
Denver Health and Hospital Authority
National Trauma Research Institute
Investigators
Principal Investigator: Fredric M Pieracci, MD, MPH Denver Health Medical Center, University of Colorado Health Science Center
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Fredric Pieracci, Principal Investigator, Denver Health and Hospital Authority
ClinicalTrials.gov Identifier: NCT01180894     History of Changes
Other Study ID Numbers: 10-0705
First Submitted: August 11, 2010
First Posted: August 12, 2010
Results First Submitted: September 16, 2015
Results First Posted: January 20, 2017
Last Update Posted: January 20, 2017
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Fredric Pieracci, Denver Health and Hospital Authority:
Trauma
Anemia
Iron
Erythropoeisis

Additional relevant MeSH terms:
Anemia
Critical Illness
Hematologic Diseases
Disease Attributes
Pathologic Processes
Iron
Ferric oxide, saccharated
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Hematinics