Actively Recruiting

Phase 4
Age: 18Years - 89Years
All Genders
NCT05292001

Single-dose Intravenous Iron Therapy for Anemia After Orthopaedic Trauma

Led by Oregon Health and Science University · Updated on 2025-08-08

150

Participants Needed

1

Research Sites

208 weeks

Total Duration

On this page

Sponsors

O

Oregon Health and Science University

Lead Sponsor

C

Collins Medical Trust

Collaborating Sponsor

AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

Single-dose Intravenous Iron Therapy for Anemia After Orthopaedic Trauma

Who Can Participate

Age: 18Years - 89Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged 18 to 89 years admitted with a lower extremity or pelvis fracture requiring surgical stabilization
  • Acute blood loss anemia defined by hemoglobin between 7.0 and 11.0 g/dL within seven days after definitive fracture surgery during hospital stay
Not Eligible

You will not qualify if you...

  • History of intolerance or hypersensitivity to intravenous iron treatment
  • Active bleeding requiring more than two units of blood transfusion during perioperative period
  • Multiple planned surgeries during trauma admission, except orthopedic staged procedures related to the included fracture
  • Pre-existing blood or clotting disorders such as thalassemia, sickle cell disease, hemophilia, von Willebrand disease, or myeloproliferative disease
  • Chronic kidney or liver disease
  • Known infections, autoimmune inflammatory conditions, or cancer
  • Pregnancy
  • Iron overload conditions defined by elevated serum ferritin, iron, or transferrin saturation levels, or related disorders like hemochromatosis
  • Members of the Jehovah's Witness faith
  • Vulnerable populations including children, patients aged 90 or older, incarcerated individuals, or those unable to give informed consent
  • Inability to stop oral iron supplements during the study
  • Current or recent (within 30 days) use of immunosuppressive drugs
  • Use of intravenous iron therapy or erythropoietin within 30 days before enrollment

AI-Screening

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Trial Site Locations

Total: 1 location

1

Oregon Health & Science University

Portland, Oregon, United States, 97239

Actively Recruiting

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Research Team

T

Talia D Trapalis, B.S.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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