IV Iron for the Anemia of Traumatic Critical Illness (IATCI)
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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 Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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 |
- Anemia [ Designated as safety issue: No ]
- 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 ]
| Estimated Enrollment: | 600 |
| Study Start Date: | June 2011 |
| Estimated Study Completion Date: | July 2013 |
| Estimated Primary Completion Date: | July 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 | 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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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| Contact: Fredric M Pieracci, MD, MPH | 303-436-4029 | fredric.pieracci@ucdenver.edu |
| Contact: Ernest E Moore, MD | 303-436-6558 | ernest.moore@dhha.org |
| United States, Maryland | |
| Johns Hopkins Hospital | Not yet recruiting |
| Baltimore, Maryland, United States, 21287 | |
| Contact: Pamela A Lipsett, MD 410-955-3739 plipsett@jhmi.edu | |
| Principal Investigator: Pamela A Lipsett, MD | |
| United States, Michigan | |
| University of Michigan Health Systems | Not yet recruiting |
| Ann Arbor, Michigan, United States | |
| Contact: Lena Napolitano, MD lenan@umich.edu | |
| Principal Investigator: Lena Napolitano, MD | |
| United States, New York | |
| NewYork Presbyterian Medical Center/Weill Cornell Medical College | Not yet recruiting |
| New York, New York, United States, 10065 | |
| Contact: Philip S Barie, MD pbarie@med.cornell.edu | |
| Principal Investigator: Philip S Barie, MD | |
| United States, Pennsylvania | |
| University of Pennsylvania | Recruiting |
| Philadelphia, Pennsylvania, United States | |
| Contact: Daniel N Holena, MD daniel.holena@uphs.upenn.edu | |
| Principal Investigator: Daniel N Holena, MD | |
| University of Pittsburgh Medical Center | Not yet recruiting |
| Pittsburgh, Pennsylvania, United States | |
| Contact: Samuel A Tischerman, MD tishermansa@upmc.edu | |
| Principal Investigator: Samuel A Tischerman, MD | |
| United States, Washington | |
| Harborview Medical Center/University of Washington | Recruiting |
| Seattle, Washington, United States | |
| Contact: Ronald V Maier, MD ronmaier@u.washington.edu | |
| Principal Investigator: Ronald V Maier, MD | |
| Principal Investigator: | Fredric M Pieracci, MD, MPH | Denver Health Medical Center, University of Colorado Health Science Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Fredric Pieracci, Principal Investigator, Denver Health and Hospital Authority |
| ClinicalTrials.gov Identifier: | NCT01180894 History of Changes |
| Other Study ID Numbers: | 10-0705 |
| Study First Received: | August 11, 2010 |
| Last Updated: | April 25, 2012 |
| Health Authority: | United States: Human Research Protection Office of the US Army Medical Research and Materiel Command |
Keywords provided by Denver Health and Hospital Authority:
|
Trauma Anemia Iron Erythropoeisis |
Additional relevant MeSH terms:
|
Anemia Critical Illness Hematologic Diseases Disease Attributes Pathologic Processes Ferric oxide, saccharated Iron Hematinics |
Hematologic Agents Therapeutic Uses Pharmacologic Actions Trace Elements Micronutrients Growth Substances Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on June 17, 2013