IV Iron for the Anemia of Traumatic Critical Illness

NCT ID: NCT01180894

Last Updated: 2018-02-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-06-30
• Study Completion Date: 2013-09-30

Brief Summary

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.

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.

Conditions

Trauma; ICU Anemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Iron sucrose

100 mg IV TIW

Group Type: ACTIVE_COMPARATOR

Iron sucrose

Intervention Type: DRUG

100 mg IV TIW

Placebo

Pacebo - Normal Saline

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Interventions

Iron sucrose

100 mg IV TIW

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Other Intervention Names

Fe sucrose; control

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Trauma Research Institute

OTHER

Sponsor Role: collaborator

Denver Health and Hospital Authority

OTHER

Sponsor Role: lead

Responsible Party

Fredric Pieracci

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Fredric M Pieracci, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Denver Health Medical Center, University of Colorado Health Science Center

Locations

Johns Hopkins Hospital

Baltimore, Maryland, United States

University of Michigan Health Systems

Ann Arbor, Michigan, United States

NewYork Presbyterian Medical Center/Weill Cornell Medical College

New York, New York, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Harborview Medical Center/University of Washington

Seattle, Washington, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 24797376 (View on PubMed)

Related Links

http://www.nationaltraumainstitute.org/

National Trauma Institute

Other Identifiers

10-0705

Identifier Type: -

Identifier Source: org_study_id