Actively Recruiting
Ferric Derisomaltose and Outcomes in the Recovery of Gynecologic Oncology: ERAS (Enhanced Recovery After Surgery)
Led by AHS Cancer Control Alberta · Updated on 2025-04-25
82
Participants Needed
1
Research Sites
90 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Ferric Derisomaltose and Outcomes in the Recovery of Gynecologic Oncology: ERAS (Enhanced Recovery After Surgery)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed written informed consent before any study procedures
- Age 18 years or older
- Undergoing elective major gynecologic oncology surgery lasting 1 hour or more with Aletti complexity score at least 1
- Surgery planned for suspected or proven gynecologic malignancy
- Expected time from recruitment to surgery between 28 and 90 days
- Screening hemoglobin less than 120 g/L and transferrin saturation below 20%
- Randomization and study infusion given between 21 and 90 days before surgery
- Negative pregnancy test within 7 days before treatment for women of childbearing potential
- Women of childbearing potential must use contraception from screening until 6 weeks post treatment
- Laboratory tests for eligibility not older than 4 weeks
You will not qualify if you...
- Known acquired iron overload or family history of haemochromatosis or thalassemia, or transferrin saturation over 50%
- Alternative causes of anemia such as B12 or folate deficiency or haemoglobinopathy
- Known allergy to ferric derisomaltose or its components
- Fever above 38°C or current use of non-prophylactic antibiotics
- Known chronic liver disease or active hepatitis
- Received erythropoietin or intravenous iron therapy within 12 weeks before planned treatment
- Liver enzymes (ALT or AST) more than three times the upper normal limit
- On immunosuppressive therapy for organ transplant or receiving/planning renal dialysis within 12 months after treatment
- Unfit for elective surgery
- Pregnancy or breastfeeding
- Unable to understand or comply with study procedures due to psychiatric, social, or substance abuse issues
- Cervical cancer stage 2A or higher
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Arthur J.E. Child Comprehensive Cancer Centre
Calgary, Alberta, Canada, T2N 5G2
Actively Recruiting
Research Team
S
Steven Bisch, MD
CONTACT
M
Michelle Kan
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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