Single-dose IV iron for anemia after orthopedic fracture surgery

Role of Single-dose Intravenous Iron Therapy for the Treatment of Anemia in the Setting of Orthopaedic Trauma: a Pilot Study

This trial will test whether a single intravenous iron infusion helps adults (18–89) with anemia after lower-extremity or pelvic fracture surgery recover with fewer complications and less fatigue.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 150 (estimated)
• Ages: 18 Years to 89 Years
• Sex: All
• Sponsor: Oregon Health and Science University (Academic / other)
• Locations: 1 site (Portland, Oregon)
• Trial ID: NCT05292001 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults 18–89 with a lower-extremity or pelvic fracture requiring surgical stabilization who develop acute blood loss anemia (Hb 7.0–11.0 g/dL) within seven days after definitive surgery and have no contraindications to IV iron.

Not a fit: Patients with active major bleeding requiring more than two units transfused, known intolerance or hypersensitivity to IV iron, or pre-existing hematologic/coagulation disorders are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, a single-dose IV iron infusion could raise hemoglobin more quickly, lessen fatigue and impaired function during recovery, and lower the need for transfusions or related complications.

How similar studies have performed: Intravenous iron has shown benefit in some other surgical and postpartum anemia settings, but its use specifically after orthopedic trauma is relatively untested and evidence is limited.

Eligibility criteria

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 this trial is running

Portland, Oregon

• 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.

Conditions Acute Blood Loss Anemia; Fracture; intravenous iron therapy; anemia; orthopaedic trauma