Actively Recruiting

Phase 4
Age: 18Years - 89Years
All Genders
ID05292001

Role of Single-dose Intravenous Iron Therapy for the Treatment of Anemia in Orthopaedic Trauma: a Pilot Study

Led by Oregon Health and Science University · Updated on 2025-08-08

150

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

O

Oregon Health and Science University

Lead Sponsor

C

Collins Medical Trust

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the effects of intravenous iron therapy (IVIT) for treating anemia caused by acute blood loss in patients with orthopedic trauma. This pilot study aims to understand whether IVIT can improve outcomes such as fatigue, physical function, and depression after traumatic fractures, compared to current standard care which often relies on blood transfusions only in severe anemia cases. The study also explores how IVIT affects immune cells and overall recovery in these patients. Participants will be randomly assigned to receive either a single infusion of low molecular weight Iron Dextran or a single infusion of normal saline as a placebo. The study includes several key aims: determining the feasibility of the study design and procedures, measuring the time it takes for hemoglobin levels to return to normal after injury, assessing patient-reported outcomes related to fatigue and mood, and evaluating laboratory markers related to iron and immune response. During the study, participants will be monitored over three months with assessments including anemia resolution rates, ferritin levels, body iron stores, and patient-reported scores on fatigue, depression, physical function, and quality of life. Researchers will track enrollment rates, protocol adherence, and participant retention. The total participation time includes this three-month follow-up period to observe recovery and treatment effects.

CONDITIONS

Brief Title

Single-dose Intravenous Iron Therapy for Anemia After Orthopaedic Trauma

Who Can Participate

Age: 18Years - 89Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged 18 to 89 years
  • Admitted with a lower extremity or pelvis fracture needing surgical stabilization
  • Acute blood loss anemia with hemoglobin between 7.0 and 11.0 g/dL within seven days after surgery during hospital admission
Not Eligible

You will not qualify if you...

  • History of intolerance or allergic reaction to intravenous iron therapy
  • Active bleeding requiring more than two units of blood transfusion during surgery
  • Multiple planned surgeries during trauma admission excluding staged orthopedic procedures
  • Pre-existing blood or clotting disorders (e.g., thalassemia, sickle cell disease, hemophilia, von Willebrand's disease, myeloproliferative disease)
  • Chronic kidney or liver disease
  • Known infections, inflammatory conditions (e.g., lupus, rheumatoid arthritis, ankylosing spondylitis), or cancer
  • Pregnancy
  • Iron overload conditions or high iron blood levels
  • Members of the Jehovah's Witness faith
  • Vulnerable populations including children, people aged 90 or older, incarcerated individuals, or those unable to consent
  • Inability to avoid oral iron supplements during the study
  • Current or recent (within 30 days) use of immunosuppressive drugs
  • Use of intravenous iron therapy or erythropoietin within the past 30 days

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Single administration with follow-up for 3 months

Participants receive a single infusion of either low molecular weight Iron Dextran or normal saline to treat anemia after orthopedic trauma.

1 infusion visit and multiple follow-up visits over 3 months

Trial Site Locations

Total: 1 location

1

Oregon Health & Science University

Portland, Oregon, United States, 97239

Actively Recruiting

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Research Team

T

Talia D Trapalis, B.S.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Treatment of iron deficiency anemia in orthopedic surgery with intravenous iron: efficacy and limits: a prospective study.

Oliver M Theusinger, Pierre-François Leyvraz, Urs Schanz...

https://pubmed.ncbi.nlm.nih.gov/18043060

Patients with pertrochanteric hip fracture may benefit from preoperative intravenous iron therapy: a pilot study.

Jorge Cuenca, José A García-Erce, Manuel Muñoz...

https://pubmed.ncbi.nlm.nih.gov/15383017

Perioperative stimulation of erythropoiesis with intravenous iron and erythropoietin reduces transfusion requirements in patients with hip fracture. A prospective observational study.

J A García-Erce, J Cuenca, M Muñoz...

https://pubmed.ncbi.nlm.nih.gov/15877644

Efficacy of perioperative intravenous iron therapy for transfusion in orthopedic surgery: A systematic review and meta-analysis.

Hye Won Shin, Jeong Jun Park, Hyun Jung Kim...

https://pubmed.ncbi.nlm.nih.gov/31059515

Single-dose intravenous iron infusion or oral iron for treatment of fatigue after postpartum haemorrhage: a randomized controlled trial.

C Holm, L L Thomsen, A Norgaard...

https://pubmed.ncbi.nlm.nih.gov/28198084