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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

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

Select...

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Evaluation of protocol adherence

Fatigue

Rate of participant enrollment and screen failures

Secondary outcome measures

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

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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Collins Medical TrustOTHER

4 Previous Clinical Trials

115 Total Patients Enrolled

Medical Research FoundationUNKNOWN

Oregon Health and Science UniversityLead Sponsor

974 Previous Clinical Trials

7,385,762 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is Iron-Dextran Complex Injection [InFed] considered a safe therapeutic option?

"There is ample clinical evidence of InFed's safety, thus it was rated a 3 on the scale."

Answered by AI

Is this research initiative open to adults above the age of 25?

"The medical study is looking for patients aged from 18 to 89. On the other hand, there exist 158 trials available for minors and 442 clinical trials for seniors."

Answered by AI

How many subjects are currently participating in this research?

"Affirmatively, the information on clinicaltrials.gov confirms that this medical study is actively seeking participants; it was initially published on May 2nd 2022 and updated as recently as October 4th 2022. The trial requires 150 individuals to be enrolled from a single centre."

Answered by AI

Do I meet the eligibility requirements to be involved in this clinical research?

"This clinical trial seeks to enrol 150 participants aged 18-89 who have suffered from fracture or bone trauma. To meet the necessary criteria, patients must demonstrate signs of acute blood loss anemia as evidenced by a hemoglobin concentration between 7.0 and 11.0 g/dL post-operatively during their hospital stay."

Answered by AI

Are new participants able to enroll in this trial at present?

"Based on the information available at clinicaltrials.gov, this trial is accepting applicants and was first posted in May of 2022 with its most recent update being issued in October of the same year."

Answered by AI

Recent research and studies

Vox SanguinisJournal

Perioperative Stimulation of Erythropoiesis with Intravenous Iron and Erythropoietin Reduces Transfusion Requirements in Patients with Hip Fracture. A Prospective Observational Study

Garcia-Erce, J. A., J. Cuenca, M. Munoz, M. Izuel, A. A. Martinez, A. Herrera, V. M. Solano, and F. Martinez. 2005. “Perioperative Stimulation of Erythropoiesis with Intravenous Iron and Erythropoietin Reduces Transfusion Requirements in Patients with Hip Fracture. A Prospective Observational Study”. Vox Sanguinis. Wiley. doi:10.1111/j.1423-0410.2005.00627.x.

Plos OneJournal

Efficacy of Perioperative Intravenous Iron Therapy for Transfusion in Orthopedic Surgery: A Systematic Review and Meta-analysis

Shin, Hye Won, Jeong Jun Park, Hyun Jung Kim, Hae Sun You, Sung Uk Choi, and Mee Ju Lee. 2019. “Efficacy of Perioperative Intravenous Iron Therapy for Transfusion in Orthopedic Surgery: A Systematic Review and Meta-analysis”. Edited by Wen-Chih Wu. Plos One. Public Library of Science (PLoS). doi:10.1371/journal.pone.0215427.

Patient Related Outcome MeasuresJournal

Strauss, William, and Michael Auerbach. 2018. “Health-related Quality of Life in Patients with Iron Deficiency Anemia: Impact of Treatment with Intravenous Iron”. Patient Related Outcome Measures. Informa UK Limited. doi:10.2147/prom.s169653.

Blood TransfusionJournal

On the Role of Iron Therapy for Reducing Allogeneic Blood Transfusion in Orthopaedic Surgery