Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:30 AM
Ignite Modification Date:
2025-12-25 @ 1:30 AM
NCT ID:
NCT01180894
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01180894
Study Brief:
Protocol Section:
NCT01180894