NCT05304442 · Baylor College of Medicine
IV Iron Trial for Anemia Related to Uterine Bleeding in Female Patients Presenting to the Emergency Department
What this study is about
The primary aim of this randomly assigned trial is to assess the effectiveness of IV Ferric Derisomaltose vs taken by mouth Iron in the management of women with severe Iron Deficiency Anemia due to Uterine Bleeding in the emergency department.
View original scientific 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Houston, Texas
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 5, 2024 · Source of record for eligibility and locations