RECRUITING

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

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Conditions

Anemia, Iron DeficiencyUterine BleedingIV IronEmergency DepartmentIron Deficiency Anemia

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Intravenous Ferric Derisomaltose for Moderate to Severe Anemia Due to Uterine Bleeding in the Emergency Department: a Randomized Trial

Quick Facts

Study Start:2022-09-15
Study Completion:2025-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05304442

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.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Sub-acute or chronic uterine blood loss;
  2. * Moderate to Severe Anemia, defined as Hgb less than or equal to 9.0 g/dl;
  3. * Iron deficiency: Serum ferritin less than or equal to 30 ng/mL;
  4. * Eligible for discharge from the ED following treatment;
  5. * Patient able to return for planned follow-up visits at 3 and 6 weeks;
  6. * Patient able to be reached by telephone;
  7. * Willing and able to provide consent for participation.
  1. * Patient requiring hospitalization for any reason;
  2. * Pregnant or nursing;
  3. * Incarcerated/Prisoner;
  4. * Weight \< 50 kg;
  5. * History of hypersensitivity reactions, as specified, known hypersensitivity to any formulation of parenteral iron;
  6. * History of any anaphylactic allergy;
  7. * Recent receipt of IV iron, erythropoiesis-stimulating agents;
  8. * Erythropoiesis-stimulating agent use within 8 weeks prior to ED visit;
  9. * Parenteral iron within 4 weeks prior to ED visit;
  10. * Scheduled/planned use of parenteral iron or ESA during study period;
  11. * Receipt of blood transfusion at index visit;
  12. * Planned elective major surgery during study period;
  13. * Other current or recent hematologic therapy, as specified;
  14. * Current or planned use of antithrombotic therapy (antiplatelet agents or anticoagulants) within study period (Non-aspirin NSAIDs are NOT a contraindication);
  15. * Known bleeding disorder platelets \< 100,000';
  16. * Other significant underlying comorbidity, as specified:
  17. * Active rheumatologic disease, or rheumatologist disease requiring treatment, such as rheumatoid arthritis, systemic lupus erythematosus, or mixed connective tissue disease;
  18. * Acute heart failure or NYHA II-IV chronic heart failure;
  19. * Inflammatory bowel disease;
  20. * Cirrhosis or Decompensated liver disease;
  21. * Chronic kidney disease, stage III or greater (eGFR \< 60);
  22. * Current Systemic Infection (e.g. pneumonia, pelvic inflammatory disease, pyelonephritis). \*Cystitis or cervicitis is NOT an exclusion
  23. * Any other medical or surgical condition that in the opinion of the treating physician may result in patient being unsuitable for trial participation

Contacts and Locations

Study Contact

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

Study Locations (Sites)

Ben Taub Hospital
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: Baylor College of Medicine

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 Registration Dates

Study Start Date2022-09-15
Study Completion Date2025-04

Study Record Updates

Study Start Date2022-09-15
Study Completion Date2025-04

Terms related to this study

Keywords Provided by Researchers

  • IV Iron
  • Emergency Department
  • Iron Deficiency Anemia
  • Uterine Bleeding

Additional Relevant MeSH Terms

  • Anemia, Iron Deficiency
  • Uterine Bleeding