Status:
RECRUITING
Single-dose Intravenous Iron Therapy for Anemia After Orthopaedic Trauma
Lead Sponsor:
Oregon Health and Science University
Collaborating Sponsors:
Collins Medical Trust
Medical Research Foundation
Conditions:
Acute Blood Loss Anemia
Fracture
Eligibility:
All Genders
18-89 years
Phase:
PHASE4
Brief Summary
Acute blood loss in orthopaedic trauma and operative fracture care contributes substantially to perioperative anemia, which places participants at increased risk for complications including surgical s...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Patients age 18-89 admitted with a lower extremity or pelvis fracture requiring surgical stabilization
- 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:
- History of intolerance or hypersensitivity to IV iron supplementation
- Active hemorrhage requiring greater than two units (whole blood or pRBCs) transfused perioperatively
- 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
- Pre-existing hematologic or coagulation disorder (e.g., thalassemia, sickle cell disease, hemophilia, von Willibrand's disease, or myeloproliferative disease)
- Diagnosis of chronic kidney disease and/or chronic liver disease
- Known infection, inflammatory condition (e.g., systemic lupus erythematosus, rheumatoid arthritis, and ankylosing spondylitis), or malignancy
- Pregnancy
- 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)
- Patients that are tenets of the Jehovah's Witness faith
- Vulnerable populations including pediatric patients, geriatric populations 90 or older, incarcerated individuals, those unable to provide informed consent
- Inability to refrain from oral iron supplementation during study period
- Current or recent (within 30 days) use of immunosuppressive agents
- Use of any intravenous iron therapy or recombinant human erythropoietin formulation within the previous 30 days
Exclusion
Key Trial Info
Start Date :
June 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2026
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT05292001
Start Date
June 1 2022
End Date
May 31 2026
Last Update
August 8 2025
Active Locations (1)
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1
Oregon Health & Science University
Portland, Oregon, United States, 97239