Iron infusion before surgery for iron-deficiency anemia in gynecologic cancer
Tests ferric derisomaltose against placebo for anemia in people having gynecologic cancer surgery.
Key facts
- Who runs it
- AHS Cancer Control Alberta
- Where
- Canada1 site in 1 countryChoose a country to see its sites
- Trial code
- Registry title
- Ferric Derisomaltose and Outcomes in the Recovery of Gynecologic Oncology: ERAS (Enhanced Recovery After Surgery)
- Status
- Recruiting
- Phase
- Phase 3
- People taking part
- 82 people, planned
- Started
- 8 Apr 2025
- Expected to end
- 30 Dec 2027
- Type of study
- Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- Ferric derisomaltose
- Placebo
- Record updated
- 28 October 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for women aged 18 or older with iron-deficiency anemia who are planned for major surgery for suspected or proven gynecologic cancer. They get IV ferric derisomaltose or placebo before surgery.
- Age
- 18 years and older
- Sex
- Female
- Disease stage
- Suspected or proven gynecologic cancer, planned for elective major surgery lasting 1 hour or more, with an Aletti complexity score of at least 1. Surgery expected 28-90 days after recruitment. People with cervical cancer of clinical stage 2A or higher cannot join.
- Earlier treatment
- No erythropoietin or IV iron in the 12 weeks before the study drug.
- Biomarker or test result
- Screening haemoglobin less than 120 g/L and transferrin saturation (TSAT) <20%. These test results must be no older than 4 weeks.
Main reasons for not taking part
- Iron overload, TSAT >50%, or family history of haemochromatosis or thalassemia
- Another known cause of anemia, such as B12 or folate deficiency
- Chronic liver disease, active hepatitis, or ALT or AST above three times the upper limit of normal
- Immunosuppressive treatment for an organ transplant, or current or planned kidney dialysis
- Pregnancy or breastfeeding
The registry criteria, word for word
Show all 20 criteriaShow less
Who can take part
- Signed written informed consent prior to initiation of any study specific activities/procedures
- Age ≥ 18 years old
- Patients undergoing elective major surgery on the gynecologic oncology service with the following criteria will be considered for inclusion:; The indication for the operation may be for suspected or proven gynecologic malignancy; Major surgery is defined as an operation of a duration of 1 hour or greater, with an Aletti complexity score of at least 1; The expected time from recruitment to surgery is 28-90 days
- Screening haemoglobin less than 120 g/L and transferrin saturation (TSAT) <20%
- Randomization and administration of study infusion a minimum of 21 days and maximum 90 days before planned operation
- Negative pregnancy test for women of childbearing potential (WOCBP) (within 7 days prior to treatment)
- WOCBP must adhere to the contraception requirement from screening throughout the study period until 6 weeks post treatment
- Laboratory data used for determination of eligibility (Hemoglobin and Transferrin saturation) at the baseline visit must not be older than 4 weeks
Who cannot take part
- Received erythropoietin or IV iron therapy within previous 12 weeks prior to planned study drug treatment
- Immunosuppressive therapy (for solid organ transplant), or renal dialysis (current, or planned within next 12 months following treatment with study drug or placebo)
- Unfit for elective surgery
- Known history of acquired iron overload, or family history of haemochromatosis or thalassemia, or TSAT >50%
- Known hypersensitivity to Ferric derisomaltose/iron isomaltoside (Monoferric®) or its excipients
- Known chronic liver disease or active hepatitis
- Unable to fully comprehend and/or perform study procedures and patients with psychiatric illness/social situations/substance abuse that would limit compliance with study requirements
- Cervical cancer with a clinical stage of 2A or greater
- Alanine transaminase (ALT) or aspartate transaminase (AST) above three times the upper limit of normal (ULN) range
- Known alternative cause for anemia (e.g., B12 or folate deficiency, or haemoglobinopathy)
- Temperature >38C or patient on non-prophylactic antibiotics
- Pregnancy or lactation
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
Iron deficiency has been reported in approximately 35% of patients with a gynecologic malignancy. Blood transfusions are known to be immunosuppressive and carry immediate and long-term risks. Pre-operative blood transfusion in gynecologic oncology patients is associated with higher rates of surgical site infection, length of stay, composite morbidity, cancer recurrence, and mortality. Pre-operative intravenous iron formulations have been shown in benign gynecology and other surgical specialities to increase pre-operative hemoglobin and decrease post-operative transfusion rates.
Read full original descriptionShow less
This is a randomized double-blinded clinical trial evaluating the effects of treating patients undergoing gynecologic oncology surgery with intravenous ferric derisomaltose to correct pre-operative iron-deficiency anemia.
The study aims to assess the effectiveness of preoperative ferric derisomaltose/iron isomaltoside compared to placebo in correcting preoperative hemoglobin in patients undergoing surgery for gynecologic malignancy.
The 2 groups in the trial
- Iron Therapy ArmTreatment being tested
500 or 1000mg of IV Ferric Derisomaltose in 100mL normal saline will be administered intravenously over 1 hour. Participants with bodyweight \<50kg will receive 500mg, participants with bodyweight \>50kg will receive 1000mg to ensure no patient exceeds the manufacturer's recommended dose of 20mg/kg bodyweight.
Treatment: Ferric derisomaltose
- Placebo ArmPlacebo, for comparison
100mL of normal saline will be administered intravenously over 1 hour between 21 and 90 days preceding surgical intervention.
Treatment: Placebo
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Feasibility and Efficacy of Intravenous Ferric Derisomaltose to Correct Pre-operative Iron-deficiency Anemia in Patients Undergoing Gynecologic Oncology Surgery: a Pilot Randomized Double Blinded Parallel Group Placebo-controlled Study
- Plain-language title
- Iron infusion before surgery for iron-deficiency anemia in gynecologic cancerGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 15 November 2026.
- Record updated
- 28 October 2026