Ferric Derisomaltose and Outcomes in the Recovery of Gynecologic Oncology: ERAS (Enhanced Recovery After Surgery)
Trial Parameters
Brief 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 Criteria
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 tre