Single-dose Intravenous Iron Therapy for Anemia After Orthopaedic Trauma

• Status: Not yet recruiting
• Trial end date: 2024-04-01
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Oregon Health and Science University
• Collaborators: Collins Medical Trust; Medical Research Foundation
• Treatments: Dextrans; Iron-Dextran Complex

Criteria

Inclusion Criteria:

• Participants age 18-89 admitted for operative fracture care of a lower extremity fractures excluding pelvic injuries

• Acute blood loss anemia as defined by hemoglobin concentration between 7.5-10g/dL on post-operative day 1

Exclusion Criteria:

• History of intolerance or hypersensitivity to IV iron supplementation

• Active hemorrhage requiring any pRBC transfusions perioperatively

• Planned staged orthopaedic procedures

• 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 > 160 μg/ dL, or serum transferrin saturation ≥ 50%) or any condition associated with iron overload (e.g., hemochromatosis and aceruloplasminemia)

• Participants 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 recombinant human erythropoietin formulation within the previous 30 days