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Single-dose Intravenous Iron Therapy for Anemia After Orthopaedic Trauma

StatusRecruiting
PhasePhase 4
Started
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Record status
This record was last updated August 8, 2025 (before its estimated May 31, 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Notable Primary and study completion dates: May 31, 2024 to May 31, 2026
    • Site contact updated
    v5
  2. Notable Start date: May 2, 2022 to Jun 1, 2022v4 Show 4 more changesShow less
    • Primary endpoints revised (3)
    • Primary and study completion dates: Apr 1, 2024 to May 31, 2024
    • Eligibility criteria expanded, about 47 words
    • Secondary endpoints expanded, about 51 words
  3. Minor Eligibility criteria expanded, about 4 wordsv3
  4. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Apr 1, 2022 to May 2, 2022
    • Eligibility criteria expanded, about 2 words
    v2
  5. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05292001
Lead Sponsor Oregon Health and Science University
Collaborators: Collins Medical Trust, Medical Research Foundation
Conditions
(from sponsor)
Acute Blood Loss Anemia, Fracture
Related terms Anemia, Fractures, Bone
Enrollment 150 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov