Single-dose Intravenous Iron Therapy for Anemia After Orthopaedic Trauma

Oregon Health & Science University (OHSU)

Status and phase: Enrolling; Phase 4

Conditions: Fracture; Acute Blood Loss Anemia

Treatments: Drug: Iron-Dextran Complex Injection [InFed]; Other: Saline Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05292001

22441

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 89 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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150 participants in 2 patient groups, including a placebo group

Treatment

Experimental group

Description:

Single infusion of low molecular weight Iron Dextran

Treatment:

Drug: Iron-Dextran Complex Injection [InFed]

Placebo

Placebo Comparator group

Description:

Single infusion of normal saline

Treatment:

Other: Saline Placebo