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
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.
• 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.