Single-dose IV iron for anemia after orthopedic fracture surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults admitted with a lower-extremity or pelvis fracture who have acute blood loss anemia (hemoglobin 7.0–11.0 g/dL within seven days after definitive surgical stabilization) receive either a single infusion of iron-dextran or a saline placebo while hospitalized. The trial compares short-term recovery outcomes, hemoglobin recovery, and complication rates between the iron and placebo groups. Key exclusions include known hypersensitivity to IV iron, active hemorrhage requiring more than two units transfused perioperatively, multiple planned non-orthopaedic procedures, and pre-existing hematologic or coagulation disorders. The intervention is delivered as a single intravenous dose in the perioperative inpatient setting at the lead site.

Why it matters

Who can join: the full rules

Inclusion criteria:

1. Patients age 18-89 admitted with a lower extremity or pelvis fracture requiring surgical stabilization
2. Acute blood loss anemia as defined by hemoglobin concentration between 7.0-11.0g/dL within seven days post-operatively from definitive fracture stabilization during the hospital admission

Exclusion criteria:

1. History of intolerance or hypersensitivity to IV iron supplementation
2. Active hemorrhage requiring greater than two units (whole blood or pRBCs) transfused perioperatively
3. 1\. Multiple planned operative procedures during the trauma admission, excluding orthopaedic staged procedures for the fracture meeting inclusion criterion one (such as temporizing external fixator application and washout for open fracture) in which subjects otherwise meet qualifications for enrollment after definitive stabilization
4. Pre-existing hematologic or coagulation disorder (e.g., thalassemia, sickle cell disease, hemophilia, von Willibrand's disease, or myeloproliferative disease)
5. Diagnosis of chronic kidney disease and/or chronic liver disease
6. Known infection, inflammatory condition (e.g., systemic lupus erythematosus, rheumatoid arthritis, and ankylosing spondylitis), or malignancy
7. Pregnancy
8. Iron overload (defined as serum ferritin concentration ≥ 1,000ng/mL, serum iron concentration \> 160μg/ dL, or serum transferrin saturation ≥ 50%) or any condition associated with iron overload (e.g., hemochromatosis and aceruloplasminemia)
9. Patients that are tenets of the Jehovah's Witness faith
10. Vulnerable populations including pediatric patients, geriatric populations 90 or older, incarcerated individuals, those unable to provide informed consent
11. Inability to refrain from oral iron supplementation during study period
12. Current or recent (within 30 days) use of immunosuppressive agents
13. Use of any intravenous iron therapy or recombinant human erythropoietin formulation within the previous 30 days

Where it's running

• Oregon Health & Science University
  Portland, Oregon, United States Recruiting

Study contacts

• Principal investigator: Zachary M Working, MD — Oregon Health and Science University
• Study coordinator: Talia D Trapalis, B.S.
• Email: trapalis@ohsu.edu
• Phone: 5034945348

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.