IV Iron for the Anemia of Traumatic Critical Illness (IATCI)
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.
|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 ]
|Study Start Date:||June 2011|
|Study Completion Date:||September 2013|
|Primary Completion Date:||September 2013 (Final data collection date for primary outcome measure)|
Active Comparator: Iron sucrose
100 mg IV TIW
Drug: Iron sucrose
100 mg IV TIW
|Placebo Comparator: Placebo||Drug: Placebo|
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.
|United States, Maryland|
|Johns Hopkins Hospital|
|Baltimore, Maryland, United States, 21287|
|United States, Michigan|
|University of Michigan Health Systems|
|Ann Arbor, Michigan, United States|
|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|
|University of Pittsburgh Medical Center|
|Pittsburgh, Pennsylvania, United States|
|United States, Washington|
|Harborview Medical Center/University of Washington|
|Seattle, Washington, United States|
|Principal Investigator:||Fredric M Pieracci, MD, MPH||Denver Health Medical Center, University of Colorado Health Science Center|