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 (FORGE)

NCT05467319 Phase 3 UNKNOWN

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.

Details

Lead sponsor	Alberta Health Services, Calgary
Phase	Phase 3
Status	UNKNOWN
Enrolment	82
Start date	2022-09-30
Completion	2023-12

Conditions

• Gynecologic Cancer
• Anemia, Iron Deficiency
• Surgery

Interventions

• Ferric Derisomaltose Injection
• Normal saline

Primary outcomes

• Preoperative hemoglobin level — 0 to 3 days prior to planned surgical intervention
  Hemoglobin measured, in g/L, following intervention prior to planned gynecologic surgery.