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

Sponsor

Baylor College of Medicine (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05304442

Collaborator

Pharmacosmos Therapeutics, Inc. (Other)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

RandomizedRandomized

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

Anticipated Study Start Date :

Sep 1, 2022

Anticipated Primary Completion Date :

Oct 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

mean change in hemoglobin concentration [3 weeks]
participants will have increased hemoglobin concentrations

Secondary Outcome Measures

mean change in hemoglobin concentration [6 weeks]
participants will have increased hemoglobin concentrations

Other Outcome Measures

mean change in ferritin [3 weeks]
participants will have increased ferritin
mean change in ferritin [6 weeks]
participants will have increased ferritin
median number of transfusions [6 weeks]
compare between the two arms
median number of return Emergency Department visits [6 weeks]
compare between the two arms
adverse events [6 weeks]
compare between the two arms

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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