N/A
N=150
IV Iron for the Anemia of Traumatic Critical Illness
Trauma · ICU Anemia
Bottom Line
View on ClinicalTrials.gov: NCT01180894 ↗Enrolled (actual)
150
Serious AEs
6.0%
Results posted
Jan 2017
Primary outcome: Primary: RBC Transfusion — 47; 55 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Iron sucrose (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Denver Health and Hospital Authority
- Primary completion
- Sep 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY RBC Transfusion |
47; 55 | — |
| SECONDARY Iron-deficient Erythropoeisis (IDE) |
118; 118 | — |
| SECONDARY Infection |
1; 1 | — |
| SECONDARY The Number of Participants Who Died |
7; 2 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT01180894). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.