Recruiting

Iron Therapy

Sponsor:

Oregon Health and Science University

Code:

NCT05292001

Conditions

Acute Blood Loss Anemia

Fracture

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Iron-Dextran Complex Injection [InFed]

Saline Placebo

Study Details

Brief 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.

Conditions

Acute Blood Loss Anemia

Fracture

Study ID

NCT05292001

Start date

Jun 1, 2022

Status verified date

Aug, 2025

Completion date

May 31, 2026

Anticipated

Primary completion date

May 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment

Single infusion of low molecular weight Iron Dextran

placebo comparator: Placebo

Single infusion of normal saline

Interventions

Iron-Dextran Complex Injection [InFed]

single 1000mg dose

Saline Placebo

Normal saline

Primary outcome measure

  • Rate of participant enrollment and screen failures [ Time Frame: 3 months ]
  • Evaluation of protocol adherence [ Time Frame: 3 months ]
  • Patient Reported Outcome Scores: Fatigue [ Time Frame: 3 months ]

Central Contacts and Locations

Central contacts

Talia D Trapalis, B.S.

5034945348trapalis@ohsu.edu

Locations

Oregon Health & Science University

Recruiting

Portland, Oregon, United States, 97239

Contacts

Talia D Trapalis, B.S

503-494-5348trapalis@ohsu.edu

Zachary M Working, MD

4254441717workingz@ohsu.edu

More Information

Sponsor

Oregon Health and Science University

Last update posted

Aug 8, 2025

Last verified

Aug, 2025

Keywords

  • intravenous iron therapy
  • anemia
  • orthopaedic trauma

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Oregon Health and Science University on 2025-08-08.