Single-dose Intravenous Iron Therapy for Anemia After Orthopaedic Trauma

Launched by OREGON HEALTH AND SCIENCE UNIVERSITY · Mar 18, 2022

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment for patients who experience anemia, or low red blood cell levels, after suffering a fracture or undergoing surgery for a broken bone. The researchers want to see if giving patients a single dose of intravenous iron therapy (IVIT) can help improve their hemoglobin levels more quickly and safely than the current standard treatment, which often involves blood transfusions. Participants will be monitored for how well they recover from their anemia, including any changes in fatigue, physical ability, and mood.

To be eligible for this trial, patients need to be between 18 and 89 years old and have a specific type of anemia after a fracture that requires surgery. However, certain patients cannot participate, such as those with specific medical conditions or those who have recently received other iron treatments. If you join the trial, you’ll receive iron therapy and be closely monitored to see how it helps your recovery. This study aims to provide more effective treatment options for patients with traumatic injuries, potentially leading to better health outcomes and a smoother recovery process.

Gender

ALL

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