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Single-dose Intravenous Iron Therapy for Anemia After Orthopaedic Trauma

Sponsor
Oregon Health and Science University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05292001
Collaborator
Collins Medical Trust (Other), Medical Research Foundation (Other)
150
Enrollment
1
Location
2
Arms
23
Anticipated Duration (Months)
6.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Iron-Dextran Complex Injection [InFed]
  • Other: Saline Placebo
 Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
150 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized controlled trialRandomized controlled trial
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Role of Single-dose Intravenous Iron Therapy for the Treatment of Anemia in the Setting of Orthopaedic Trauma: a Pilot Study
Actual Study Start Date :
May 2, 2022
Anticipated Primary Completion Date :
Apr 1, 2024
Anticipated Study Completion Date :
Apr 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment

Single infusion of low molecular weight Iron Dextran

Drug: Iron-Dextran Complex Injection [InFed]
single 1000mg dose
Other Names:
  • INFeD

    		•
    Placebo Comparator: Placebo

    Single infusion of normal saline

    Other: Saline Placebo
    Normal saline

    Outcome Measures

    Primary Outcome Measures

    1. Patient Reported Outcome Scores: Depression [3 months]

      PROMIS bank v1.0 - depression. Computer adaptive test. 28 question bank . A higher PROMIS T-score represents more of the concept being measured

    2. Patient Reported Outcome Scores: Fatigue [3 months]

      PROMIS bank v1.0 - fatigue. Computer adaptive test. 95 question bank. A higher PROMIS T-score represents more of the concept being measured.

    3. Patient Reported Outcome Scores: Physical Function [3 months]

      PROMIS bank v1.2 - physical function. Computer adaptive test,44 question bank. A higher PROMIS T-score represents more of the concept being measured

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 89 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Participants age 18-89 admitted for operative fracture care of a lower extremity fractures excluding operative pelvic injuries

    • Acute blood loss anemia as defined by hemoglobin concentration between 7.5-11g/dL postoperatively during the hospital admission.

    Exclusion Criteria:

    • History of intolerance or hypersensitivity to IV iron supplementation

    • Active hemorrhage requiring any pRBC transfusions perioperatively

    • Planned staged orthopaedic procedures

    • Pre-existing hematologic or coagulation disorder (e.g., thalassemia, sickle cell disease, hemophilia, von Willibrand's disease, or myeloproliferative disease)

    • Diagnosis of chronic kidney disease and/or chronic liver disease

    • Known infection, inflammatory condition (e.g., systemic lupus erythematosus, rheumatoid arthritis, and ankylosing spondylitis), or malignancy

    • Pregnancy

    • Iron overload (defined as serum ferritin concentration ≥ 1,000ng/mL, serum iron concentration > 160 μg/ dL, or serum transferrin saturation ≥ 50%) or any condition associated with iron overload (e.g., hemochromatosis and aceruloplasminemia)

    • Participants that are tenets of the Jehovah's Witness faith

    • Vulnerable populations including pediatric patients, geriatric populations 90 or older, incarcerated individuals, those unable to provide informed consent

    • Inability to refrain from oral iron supplementation during study period

    • Current or recent (within 30 days) use of immunosuppressive agents

    • Use of any recombinant human erythropoietin formulation within the previous 30 days

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Oregon Health & Science University Portland Oregon United States 97239

    Sponsors and Collaborators

    • Oregon Health and Science University
    • Collins Medical Trust
    • Medical Research Foundation

    Investigators

    • Principal Investigator: Zachary M Working, MD, Oregon Health and Science University

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    Zachary Working, Director of Orthopaedic Trauma, Assistant Professor, Oregon Health and Science University
    ClinicalTrials.gov Identifier:
    NCT05292001
    Other Study ID Numbers:
    • 22441
    First Posted:
    Mar 23, 2022
    Last Update Posted:
    May 13, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Zachary Working, Director of Orthopaedic Trauma, Assistant Professor, Oregon Health and Science University
    intravenous iron therapy
    anemia
    orthopaedic trauma
    Additional relevant MeSH terms:
    Anemia
    Dextrans
    Iron-Dextran Complex

    Study Results

    No Results Posted as of May 13, 2022