IV Iron Therapy for Anemia After Broken Bones

Overseen By Talia D Trapalis, B.S.

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Oregon Health and Science University

Must not be taking: Oral iron, Immunosuppressants

Disqualifiers: Intolerance to IV iron, Hematologic disorders, Chronic kidney disease, Known infection, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 1 day

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether intravenous iron therapy (IVIT) can aid recovery from anemia (low red blood cell count) after a major bone fracture, such as the leg or pelvis. Anemia can cause fatigue, weakness, and mood changes, and current treatment often involves blood transfusions, which carry risks. The study tests if IVIT, which delivers iron directly into the bloodstream, might offer a safer and more effective alternative. Individuals who recently underwent surgery for a leg or pelvis fracture and are experiencing anemia may be suitable candidates for this trial. As a Phase 4 trial, the research aims to understand how this FDA-approved and effective treatment can benefit more patients.

Do I need to stop my current medications for the trial?

The trial requires that you stop taking oral iron supplements and any immunosuppressive agents during the study. If you've used intravenous iron therapy or certain medications like recombinant human erythropoietin in the last 30 days, you cannot participate.

What is the safety track record for InFed and Saline Placebo?

Research has shown that intravenous iron therapy, like the treatment in this trial, is generally safe. Studies indicate that a single dose of low-molecular weight iron dextran, the type of iron used in this treatment, safely increases iron levels in the body. Serious side effects are rare, occurring in fewer than 1 in 200,000 cases. Most people tolerate the treatment well, with only minor reactions reported. Some may experience mild reactions during the infusion, but these do not lead to serious problems. Overall, intravenous iron therapy is considered a safe option for treating anemia, especially when avoiding high-molecular weight iron dextran. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike standard treatments for anemia after broken bones, which often involve oral iron supplements or blood transfusions, InFed offers a unique approach with a single infusion of low molecular weight Iron Dextran. This method can quickly replenish iron stores and potentially improve hemoglobin levels more rapidly. Researchers are excited because this could lead to faster recovery times and better outcomes for patients suffering from anemia after fractures. Additionally, the efficiency of a one-time infusion might improve patient compliance compared to the daily routine of oral supplements.

What evidence suggests that IV iron therapy could be an effective treatment for anemia after broken bones?

Research has shown that intravenous iron therapy, such as InFed, effectively treats anemia. In this trial, participants in the treatment arm will receive a single infusion of low molecular weight iron dextran (InFed). One study found that a single dose of InFed increased hemoglobin levels by more than 1 g/dL within eight weeks. Previous patients, including children and teenagers, experienced significant improvements in their iron levels after just one dose. Additionally, these studies reported no serious allergic reactions, indicating that InFed is safe. This makes InFed a promising option for treating anemia in patients recovering from orthopedic injuries. ^{6 7 8 9 10}

Who Is on the Research Team?

Zachary M Working, MD

Principal Investigator

Oregon Health and Science University

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am between 18 and 89 years old with a leg or pelvis fracture needing surgery.

I have low blood levels due to recent surgery for a broken bone.

Exclusion Criteria

I haven't used any IV iron therapy or erythropoietin in the last 30 days.

I have used immunosuppressive drugs in the last 30 days.

Pregnancy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single infusion of low molecular weight Iron Dextran or placebo

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness, including assessments of hemoglobin levels, fatigue, physical function, and depression

3 months

Multiple visits (in-person and virtual)

What Are the Treatments Tested in This Trial?

Interventions

• InFed
• Saline Placebo

Trial Overview 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.

How Is the Trial Designed?

Group I: Treatment Experimental Treatment 1 Intervention

Single infusion of low molecular weight Iron Dextran

Group II: Placebo Placebo Group 1 Intervention

Single infusion of normal saline

Who Is Running the Clinical Trial?

Oregon Health and Science University

Lead Sponsor

Trials

1,024

Recruited

7,420,000+

Medical Research Foundation

Collaborator

Trials

2

Recruited

220+

Collins Medical Trust

Collaborator

Trials

6

Recruited

410+

Medical Research Foundation

Collaborator

Trials

2

Recruited

220+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8087186/

A multicenter study evaluating the effectiveness and safety ... A multicenter study evaluating the effectiveness and safety of single-dose low molecular weight iron dextran vs single-dose ferumoxytol for the ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33769677/

A retrospective study of the safety and efficacy of low ... LMWID was well tolerated in children and adolescents, with most patients having their total iron deficits relieved in a single infusion.

3. sciencedirect.com sciencedirect.com/science/article/pii/S0006497119729395

Safety and Efficacy of Total Dose Infusion of Low Molecular ... No allergic or anaphylactic reactions were observed. This study demonstrated TDI of LMW ID improved hemoglobin levels more than 1 g/dL within 8 weeks.

4. ashpublications.org ashpublications.org/hematology/article/2016/1/57/21060/Single-dose-intravenous-iron-for-iron-deficiency-a

Single-dose intravenous iron for iron deficiency: a new paradigm Efficacy and safety of total dose infusion of low molecular weight iron dextran in the treatment of iron deficiency anemia during pregnancy.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT02038023

NCT02038023 | Intravaneous Iron(1000 mg Low Molecular ... To determine the percentage of women who achieve anemia correction after a single dose of 1000mg of low molecular weight iron dextran(infed). Detailed ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10032390/

Role of single-dose intravenous iron therapy for the treatment ... Use of a single high-dose infusion of low-molecular weight iron dextran is a safe method of body iron store repletion that optimises study ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05292001

Single-dose Intravenous Iron Therapy for Anemia After ... Acute blood loss anemia as defined by hemoglobin concentration between 7.0-11.0g/dL within seven days post-operatively from definitive fracture stabilization ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4111808/

Safety of intravenous iron formulations: facts and folklore - PMC The authors further concluded that when HMW iron dextran is avoided, intravenous iron is safe with an estimated serious adverse event incidence of <1:200,000.

9. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2790508

Analysis of Adverse Events and Intravenous Iron Infusion ... The findings in our study suggest that IV iron administration is generally well tolerated with a low adverse reaction rate, and the routine use ...

10. mayoclinicproceedings.org mayoclinicproceedings.org/article/s0025-6196(14)00883-0/fulltext

The Safety of Intravenous Iron Preparations Intravenous iron therapy is not associated with an increased risk of SAEs or infections. Infusion reactions are more pronounced with IV iron.