NCT05292001 Single-dose Intravenous Iron Therapy for Anemia After Orthopaedic Trauma
| NCT ID | NCT05292001 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Oregon Health and Science University |
| Condition | Acute Blood Loss Anemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2022-06-01 |
| Primary Completion | 2026-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 150 participants in total. It began in 2022-06-01 with a primary completion date of 2026-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Zachary M Working, MD
PRINCIPAL INVESTIGATOR
Oregon Health and Science University
Frequently Asked Questions
Who can join the NCT05292001 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 89 Years, studying Acute Blood Loss Anemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05292001 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05292001 currently recruiting?
Yes, NCT05292001 is actively recruiting participants. Contact the research team at trapalis@ohsu.edu for enrollment information.
Where is the NCT05292001 trial being conducted?
This trial is being conducted at Portland, United States.
Who is sponsoring the NCT05292001 clinical trial?
NCT05292001 is sponsored by Oregon Health and Science University. The principal investigator is Zachary M Working, MD at Oregon Health and Science University. The trial plans to enroll 150 participants.