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Iron deficiency has been reported in up to 35% of patients with a gynecologic malignancy. These patients often require surgical intervention to determine the stage and to treat their illness. Blood transfusions occur in approximately 14% of these surgeries and carry immediate and long-term risks, including surgical site infection, cancer recurrence, and increased surgical length of stay. Intravenous iron formulations have the potential to rapidly correct anemia in patients with gynecologic malignancy and potentially decrease blood transfusion and complications following surgery. This prospective, randomized, placebo-controlled, double blind 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 primary outcome is to assess the effectiveness of this formulation on pre-operative hemoglobin, and the feasibility of a larger, outcomes based, study in the future. Exploratory outcomes are to assess the effect of preoperative intravenous iron on surgical length of stay, complications, and patient-reported quality of life.
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Inclusion criteria
At least 18 years of age and signed written informed consent
Patients undergoing elective major surgery on the gynecologic oncology service with the following criteria will be considered for inclusion:
Screening haemoglobin less than 120g/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 (within last 7 days), and agree to use effective form of contraception until 6 weeks post treatment (if applicable)
Laboratory data used for determination of eligibility at the baseline visit must not be older than 4 weeks.
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82 participants in 2 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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