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

Sponsor
AHS Cancer Control Alberta
Study ID
NCT05407987
Phase
PHASE3
Status
Recruiting
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Conditions

  • Anemia
  • Gynecologic Cancer
  • Iron-deficiency

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ferric derisomaltose — DRUG
    Ferric Derisomaltose is a solution based iron supplement provided in 100 mg elemental iron/mL. Patients randomized to Iron Therapy Arm will with a bodyweight \<50kg will receive 500mg of Ferric Derisomaltose, and patients with a bodyweight \>50kg will receive 1000mg of Ferric Derisomaltose, to ensure no patient exceeds the manufacturer's recommended dose of 20mg/kg. Patients will receive a single infusion between 21 and 90 days preceding surgical intervention.
  • Placebo — DRUG
    Patients randomized to the Placebo arm will receive 100mg of normal saline over 1 hour.

Study Details

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.

Key Dates

First listed
Jun 7, 2022
Start date
Apr 8, 2025
Status verified
Apr 2025
Primary completion
Dec 30, 2026
Completion
Dec 30, 2026

Study Design

Enrollment
82 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Iron Therapy Arm
    500 or 1000mg of IV Ferric Derisomaltose in 100mL normal saline will be administered intravenously over 1 hour. Participants with bodyweight \<50kg will receive 500mg, participants with bodyweight \>50kg will receive 1000mg to ensure no patient exceeds the manufacturer's recommended dose of 20mg/kg bodyweight.
  • Placebo Comparator: Placebo Arm
    100mL of normal saline will be administered intravenously over 1 hour between 21 and 90 days preceding surgical intervention.

Primary Outcome Measure

Mean preoperative haemoglobin concentration [ Time Frame: Haemoglobin concentration will be measured at baseline and 3 days prior to surgery after treatment with Ferric Derisomaltose ]

Central Contacts

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