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Ferric Derisomaltose and Outcomes in the Recovery of Gynecologic Oncology: ERAS (Enhanced Recovery After Surgery) | Clinical Trials | Clareo Health

RECRUITINGPHASE3

Ferric Derisomaltose and Outcomes in the Recovery of Gynecologic Oncology: ERAS (Enhanced Recovery After Surgery)

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

NCT05407987•AHS Cancer Control Alberta

View on ClinicalTrials.gov

Summary

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. 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.

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•1. Signed written informed consent prior to initiation of any study specific activities/procedures.
•2. Age ≥ 18 years old.
•3. Patients undergoing elective major surgery on the gynecologic oncology service with the following criteria will be considered for inclusion:
•1. The indication for the operation may be for suspected or proven gynecologic malignancy.
•2. Major surgery is defined as an operation of a duration of 1 hour or greater, with an Aletti complexity score of at least 1.
•3. The expected time from recruitment to surgery is 28-90 days.
•4. Screening haemoglobin less than 120 g/L and transferrin saturation (TSAT) \<20%.
•5. Randomization and administration of study infusion a minimum of 21 days and maximum 90 days before planned operation.
•6. Negative pregnancy test for women of childbearing potential (WOCBP) (within 7 days prior to treatment).
•7. WOCBP must adhere to the contraception requirement from screening throughout the study period until 6 weeks post treatment.
+1 more criteria

Exclusion Criteria

•1. Known history of acquired iron overload, or family history of haemochromatosis or thalassemia, or TSAT \>50%.
•2. Known alternative cause for anemia (e.g., B12 or folate deficiency, or haemoglobinopathy).
•3. Known hypersensitivity to Ferric derisomaltose/iron isomaltoside (Monoferric®) or its excipients.
•4. Temperature \>38C or patient on non-prophylactic antibiotics.
•5. Known chronic liver disease or active hepatitis.
•6. Received erythropoietin or IV iron therapy within previous 12 weeks prior to planned study drug treatment.
•7. Alanine transaminase (ALT) or aspartate transaminase (AST) above three times the upper limit of normal (ULN) range.
•8. Immunosuppressive therapy (for solid organ transplant), or renal dialysis (current, or planned within next 12 months following treatment with study drug or placebo).
•9. Unfit for elective surgery.
•10. Pregnancy or lactation.
+2 more criteria

Locations (1)

Arthur J.E. Child Comprehensive Cancer Centre

Calgary, Alberta, Canada

Key Dates

Start Date

April 8, 2025

Primary Completion Date

December 30, 2026

Completion Date

December 30, 2026

Last Updated

April 25, 2025

Enrollment

ESTIMATED participants

Conditions

Gynecologic CancerAnemiaIron-deficiency

Interventions

Ferric derisomaltose

DRUG

Placebo

DRUG

Contacts

Steven Bisch, MD

CONTACT

403-521-3721 Steven.Bisch@ahs.ca

Michelle Kan

CONTACT

michelle.kan@ahs.ca

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 25, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Ferric Derisomaltose and Outcomes in the Recovery of Gynecologic Oncology: ERAS (Enhanced Recovery After Surgery)

Inclusion Criteria

Exclusion Criteria

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