NCT05467319

Ferric Derisomaltose/Iron Isomaltoside and Outcomes in the Recovery of Gynecologic Oncology ERAS

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 82 (estimated)
• Sponsor: Alberta Health Services, Calgary · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Gynecologic Cancer
• Anemia, Iron Deficiency
• Surgery

Interventions

Type	Name	Description
DRUG	Ferric Derisomaltose Injection	1000mg of ferric derisomaltose in 100mL of normal saline by intravenous infusion
DRUG	Normal saline	100 mL of 0.9% normal saline (w/v) by intravenous infusion

Timeline

• Start date: 2022-09-30
• Primary completion: 2023-09-01
• Completion: 2023-12-01
• First posted: 2022-07-20
• Last updated: 2022-07-20