IV Iron Trial for Anemia Related to Uterine Bleeding in Female Patients Presenting to the Emergency Department

January 10, 2024 updated by: Stephen Boone MD, Baylor College of Medicine

Intravenous Ferric Derisomaltose For Moderate to Severe Anemia Due To Uterine Bleeding In The Emergency Department: A Randomized Trial

The primary aim of this randomized trial is to assess the efficacy of IV Ferric Derisomaltose vs Oral Iron in the management of women with severe Iron Deficiency Anemia due to Uterine Bleeding in the emergency department.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Iron deficiency anemia (IDA) is the most common hematologic disorder in the United States and worldwide. Patients with moderate to severe anemia often present to the acute care setting for initial assessment and evaluation; women with abnormal uterine bleeding are among those at highest risk. Guidelines on management of this common condition in the emergency department (ED) are lacking.

Although IDA is commonly encountered in the ED, there is a paucity of literature addressing optimal management in this setting. Intravenous (IV) iron therapy is infrequently used in the ED despite evidence of safety and superiority to oral iron therapy in other acute care settings. Furthermore, red blood cell (RBC) transfusions may be over-utilized in hemodynamically stable patients with IDA, potentially increasing risk for transfusion reactions, infection, and allo-antibody formation among other adverse outcomes. Improved treatment of iron deficiency may reduce the need for subsequent RBC transfusions. Compared with oral iron, treatment with intravenous iron may result in improved adherence, fewer health care visits, more rapid correction of IDA, and overall improvement in quality of life.

Historically, older formulations of IV Iron, namely high-molecular weight iron dextran (HMWID), were associated with unacceptably high rates of severe allergic reactions and/or required multiple doses to replete iron stores. However, newer formulations of IV iron are not only extremely safe, but can also be administered as a single "total dose infusion" over a very short time period. These newer forms of IV iron include ferric carboxymaltose, low-molecular weight iron dextran, ferumoxytol, and ferric derisomaltose. When excluding HMWID, a meta-analysis of 97 RCTs found that there was no increase in the risk of serious adverse events (SAE's) with IV iron compared with control and no increased risk of systemic infection.

A large retrospective, "before and after" study conducted in an Italian Emergency Department demonstrated that implementation of Patient Blood Management protocols, including the use of IV iron in the emergency department, resulted in a substantial reduction in red blood cell transfusions, hospitalization, re-transfusion, length of stay and costs. Similar conclusions were reached in smaller studies by Motta et al and Khadadah et al.

The investigators recently published a retrospective cohort study examining current emergency department practices in the evaluation and management of IDA in the target population for the proposed trial. The results of this cohort study revealed that women with AUB and severe anemia are frequently seen in the Ben Taub Emergency Department, that red blood cell transfusions are commonly administered, and that IV iron is infrequently (or never) used in the ED setting. Furthermore, unplanned return visits and recurrent transfusions were common.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Sub-acute or chronic uterine blood loss;
  • Moderate to Severe Anemia, defined as Hgb less than or equal to 9.0 g/dl;
  • Iron deficiency: Serum ferritin less than or equal to 30 ng/mL;
  • Eligible for discharge from the ED following treatment;
  • Patient able to return for planned follow-up visits at 3 and 6 weeks;
  • Patient able to be reached by telephone;
  • Willing and able to provide consent for participation.

Exclusion Criteria:

  • Patient requiring hospitalization for any reason;
  • Pregnant or nursing;
  • Incarcerated/Prisoner;
  • Weight < 50 kg;
  • History of hypersensitivity reactions, as specified, known hypersensitivity to any formulation of parenteral iron;
  • History of any anaphylactic allergy;
  • Recent receipt of IV iron, erythropoiesis-stimulating agents;
  • Erythropoiesis-stimulating agent use within 8 weeks prior to ED visit;
  • Parenteral iron within 4 weeks prior to ED visit;
  • Scheduled/planned use of parenteral iron or ESA during study period;
  • Receipt of blood transfusion at index visit;
  • Planned elective major surgery during study period;
  • Other current or recent hematologic therapy, as specified;
  • Current or planned use of antithrombotic therapy (antiplatelet agents or anticoagulants) within study period (Non-aspirin NSAIDs are NOT a contraindication);
  • Known bleeding disorder platelets < 100,000';
  • Other significant underlying comorbidity, as specified:
  • Active rheumatologic disease, or rheumatologist disease requiring treatment, such as rheumatoid arthritis, systemic lupus erythematosus, or mixed connective tissue disease;
  • Acute heart failure or NYHA II-IV chronic heart failure;
  • Inflammatory bowel disease;
  • Cirrhosis or Decompensated liver disease;
  • Chronic kidney disease, stage III or greater (eGFR < 60);
  • Current Systemic Infection (e.g. pneumonia, pelvic inflammatory disease, pyelonephritis). *Cystitis or cervicitis is NOT an exclusion
  • Any other medical or surgical condition that in the opinion of the treating physician may result in patient being unsuitable for trial participation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intravenous Ferric Derisomaltose
One single dose of ferric derisomaltose, 1000 mg Intravenous over at least 20 minutes.
Drug: Ferric Derisomaltose 1000 Mg in 10 mL INTRAVENOUS SOLUTION [Monoferric]
Single Dose of IV Iron
Active Comparator: Oral Iron
ferrous sulfate 65 mg once daily for 42 days.
Drug: Ferrous Sulfate 65 mg elemental iron (325 mg tablets)
Once daily by mouth for 42 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
mean change in hemoglobin concentration
Time Frame: 3 weeks
participants will have increased hemoglobin concentrations
3 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
mean change in hemoglobin concentration
Time Frame: 6 weeks
participants will have increased hemoglobin concentrations
6 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
mean change in ferritin
Time Frame: 3 weeks
participants will have increased ferritin
3 weeks
mean change in ferritin
Time Frame: 6 weeks
participants will have increased ferritin
6 weeks
median number of transfusions
Time Frame: 6 weeks
compare between the two arms
6 weeks
median number of return Emergency Department visits
Time Frame: 6 weeks
compare between the two arms
6 weeks
adverse events
Time Frame: 6 weeks
compare between the two arms
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baylor College of Medicine

Collaborators

Pharmacosmos Therapeutics, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 15, 2022

Primary Completion (Estimated)

October 1, 2024

Study Completion (Estimated)

October 1, 2024

Study Registration Dates

First Submitted

March 22, 2022

First Submitted That Met QC Criteria

March 22, 2022

First Posted (Actual)

March 31, 2022

Study Record Updates

Last Update Posted (Actual)

January 12, 2024

Last Update Submitted That Met QC Criteria

January 10, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-49444

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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