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

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ClinicalTrials.gov Identifier: NCT05304442
Recruitment Status : Recruiting
First Posted : March 31, 2022
Last Update Posted : February 8, 2023
Pharmacosmos Therapeutics, Inc.
Information provided by (Responsible Party):
Stephen Boone MD, Baylor College of Medicine

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Anemia, Iron Deficiency Uterine Bleeding Drug: Ferric Derisomaltose 1000 Mg in 10 mL INTRAVENOUS SOLUTION [Monoferric] Drug: Ferrous Sulfate 65 mg elemental iron (325 mg tablets) Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intravenous Ferric Derisomaltose For Moderate to Severe Anemia Due To Uterine Bleeding In The Emergency Department: A Randomized Trial
Actual Study Start Date : September 15, 2022
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia Bleeding Iron

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

Primary Outcome Measures :
  1. mean change in hemoglobin concentration [ Time Frame: 3 weeks ]
    participants will have increased hemoglobin concentrations

Secondary Outcome Measures :
  1. mean change in hemoglobin concentration [ Time Frame: 6 weeks ]
    participants will have increased hemoglobin concentrations

Other Outcome Measures:
  1. mean change in ferritin [ Time Frame: 3 weeks ]
    participants will have increased ferritin

  2. mean change in ferritin [ Time Frame: 6 weeks ]
    participants will have increased ferritin

  3. median number of transfusions [ Time Frame: 6 weeks ]
    compare between the two arms

  4. median number of return Emergency Department visits [ Time Frame: 6 weeks ]
    compare between the two arms

  5. adverse events [ Time Frame: 6 weeks ]
    compare between the two arms

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05304442

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Contact: Stephen Boone, MD 8324099126 Stephen.Boone@bcm.edu
Contact: Kelly R Keene, BSN 8323682476 kelly.keene@bcm.edu

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United States, Texas
Ben Taub Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Stephen Boone, MD       stephen.boone@bcm.edu   
Sponsors and Collaborators
Baylor College of Medicine
Pharmacosmos Therapeutics, Inc.

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Responsible Party: Stephen Boone MD, Assistant Professor, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT05304442    
Other Study ID Numbers: H-49444
First Posted: March 31, 2022    Key Record Dates
Last Update Posted: February 8, 2023
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Stephen Boone MD, Baylor College of Medicine:
IV Iron
Emergency Department
Iron Deficiency Anemia
Uterine Bleeding
Additional relevant MeSH terms:
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Uterine Hemorrhage
Anemia, Iron-Deficiency
Iron Deficiencies
Hematologic Diseases
Disease Attributes
Pathologic Processes
Iron Metabolism Disorders
Metabolic Diseases
Anemia, Hypochromic
Uterine Diseases
Genital Diseases, Female
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Genital Diseases