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

Ki vehet részt

• 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

Ki nem vehet részt

• 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