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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01180894
Other study ID # 10-0705
Secondary ID
Status Completed
Phase N/A
First received August 11, 2010
Last updated January 10, 2018
Start date June 2011
Est. completion date September 2013

Study information

Verified date January 2018
Source Denver Health and Hospital Authority
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 150
Est. completion date September 2013
Est. primary completion date September 2013
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Iron sucrose
100 mg IV TIW
Placebo


Locations

Country Name City State
United States University of Michigan Health Systems Ann Arbor Michigan
United States Johns Hopkins Hospital Baltimore Maryland
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

Sponsors (2)

Lead Sponsor Collaborator
Denver Health and Hospital Authority National Trauma Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary RBC Transfusion The number of participants who underwent RBC transfusion. 42 Days
Secondary Iron-deficient Erythropoeisis (IDE) An elevated eZPP is diagnostic of Iron-deficient erythropoiesis (IDE) and reflects the bone marrow iron supply regardless of total body iron. 14 Days
Secondary Infection The number of participants with at least one infection.
Specific infections analyzed included VAP (Ventilator-Associated Pneumonia), bacteremia, and urinary tract infection (UTI).
28 Days
Secondary The Number of Participants Who Died 28 Days
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