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Iron Supplement

IV Iron Therapy for Anemia After Broken Bones

Phase 4
Recruiting
Led By Zachary M Working, MD
Research Sponsored by Oregon Health and Science University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients age 18-89 admitted with a lower extremity or pelvis fracture requiring surgical stabilization
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
Must not have
Inability to refrain from oral iron supplementation during study period
Active hemorrhage requiring greater than two units (whole blood or pRBCs) transfused perioperatively
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights
Pivotal Trial
Drug Has Already Been Approved

Summary

This trial is testing whether giving iron intravenously to people with orthopedic injuries can help them recover better by reducing anemia, fatigue, and depression.

Who is the study for?
This trial is for adults aged 18-89 with anemia due to blood loss from a lower extremity or pelvis fracture requiring surgery. Participants must have hemoglobin levels between 7.0-11.0g/dL post-surgery and cannot be on certain medications, have specific pre-existing conditions, be pregnant, or belong to the Jehovah's Witness faith.
What is being tested?
The study tests if a single dose of intravenous iron (InFed) can help people recover their normal hemoglobin levels faster after orthopaedic trauma compared to a saline placebo. It also looks at how this treatment affects fatigue, physical function, depression, and immune cells.
What are the potential side effects?
Potential side effects of InFed may include allergic reactions like itching or rash, muscle cramps, dizziness, back pain, joint pain; in rare cases severe reactions such as difficulty breathing could occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 89 years old with a leg or pelvis fracture needing surgery.
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I have low blood levels due to recent surgery for a broken bone.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I cannot stop taking oral iron supplements during the study.
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I needed more than two blood transfusions due to bleeding during surgery.
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I have a blood disorder like thalassemia or sickle cell disease.
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I have a known infection, inflammatory condition, or another type of cancer.
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I have high iron levels in my blood or a condition causing it.
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I have been diagnosed with chronic kidney or liver disease.
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I am not a child, over 90, incarcerated, or unable to consent.
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I am a member of the Jehovah's Witness faith.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Evaluation of protocol adherence
Fatigue
Rate of participant enrollment and screen failures
Secondary study objectives
Evaluation of ferritin level in response to IVIT after trauma
Evaluation of participant body iron stores in response to IVIT after trauma
Patient Reported Outcome Scores - Depression
+3 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: TreatmentExperimental Treatment1 Intervention
Single infusion of low molecular weight Iron Dextran
Group II: PlaceboPlacebo Group1 Intervention
Single infusion of normal saline

Find a Location

Who is running the clinical trial?

Medical Research FoundationOTHER
1 Previous Clinical Trials
70 Total Patients Enrolled
Collins Medical TrustOTHER
5 Previous Clinical Trials
256 Total Patients Enrolled
Oregon Health and Science UniversityLead Sponsor
1,006 Previous Clinical Trials
7,413,769 Total Patients Enrolled
~44 spots leftby Nov 2025
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