Single-dose Intravenous Iron Therapy for Anemia After Orthopaedic Trauma
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 site infection, cardiovascular complications, and even death. Anemia has further clinical implications in quality of life measures and is associated with fatigue, impaired physical performance, decreased exercise capacity, and mood disturbances. Thus, evaluation and treatment of perioperative anemia is critical in risk mitigation within orthopaedic surgery. The current standard of care for anemia is transfusion of packed red blood cells in only cases of severe anemia due to the substantial associated risks. A safer alternative is desirable because a critical number of participants do not meet the restrictive transfusion threshold and may suffer negative effects from anemia during recovery from the acute insult. The focus of this project is to pilot an investigation of the benefits of intravenous iron therapy (IVIT) in traumatically injured patients. Specifically, Aim I will determine feasibility of study design, recruitment, randomization, intervention implementation, blinded procedures, and retention. In Aim II, time to return to normal hemoglobin following traumatic orthopaedic injury will be assessed. With Aim III, the investigators will measure IVIT effect on participant-reported fatigue, physical function, and depression, and further determine if resolution of anemia is correlated to improvements in these measures in traumatically injured orthopaedic patients. Aim IV will focus on evaluating the role of IVIT on immune cells through a variety of novel laboratory assessments. The investigators expect this study to provide a better understanding of IVIT, which has the potential to alter providers' treatment approach of anemia in participants who sustain traumatic orthopaedic injury, thereby leading to decreased risks and improved recovery.
Conditions:
🦠 Acute Blood Loss Anemia 🦠 Fracture
🗓️ Study Start (Actual) 1 June 2022
🗓️ Primary Completion (Estimated) 31 May 2024
✅ Study Completion (Estimated) 31 May 2024
👥 Enrollment (Estimated) 150
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE4
Locations:
📍 Portland, Oregon, United States

📋 Eligibility Criteria

Description

    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
Ages Eligible for Study: 18 Years to 89 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 10 March 2022
  • First Submitted that Met QC Criteria 18 March 2022
  • First Posted 23 March 2022

Study Record Updates

  • Last Update Submitted that Met QC Criteria 29 January 2023
  • Last Update Posted 10 February 2023
  • Last Verified January 2023