Single-dose Intravenous Iron Therapy for Anemia After Orthopaedic Trauma

Part of paid clinical trials in Portland, Oregon.

Sponsor
Oregon Health and Science University
Study ID
NCT05292001
Phase
PHASE4
Status
Recruiting
Apply to this trial

Conditions

  • Acute Blood Loss Anemia
  • Fracture

Eligibility Criteria

Sex
ALL
Age
18 Years - 89 Years
Healthy Volunteers
Not accepted

Interventions

  • Iron-Dextran Complex Injection [InFed] — DRUG
    single 1000mg dose
  • Saline Placebo — OTHER
    Normal saline

Study Details

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.

Key Dates

Start date
Jun 1, 2022
Status verified
Aug 2025
Primary completion
May 31, 2026
Completion
May 31, 2026

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment
    Single infusion of low molecular weight Iron Dextran
  • Placebo Comparator: Placebo
    Single infusion of normal saline

Primary Outcome Measure

Rate of participant enrollment and screen failures [ Time Frame: 3 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Oregon Health & Science UniversityPortlandOregon97239
Talia D Trapalis, B.S
[email protected]
503-494-5348
Zachary M Working, MD
[email protected]
4254441717

Find similar trials in Portland, OR

By research site
Oregon Health & Science University· Portland, OR

Related Studies