Ferric Derisomaltose and Outcomes in the Recovery of Gynecologic Oncology: ERAS (Enhanced Recovery After Surgery)
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18+
SponsorAHS Cancer Control Alberta
About this trial
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.
Eligibility criteria
Qualifiers
Signed written informed consent prior to initiation of any study specific activities/procedures.
Age ≥ 18 years old.
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.
Disqualifiers
Known history of acquired iron overload, or family history of haemochromatosis or thalassemia, or TSAT >50%.
Known alternative cause for anemia (e.g., B12 or folate deficiency, or haemoglobinopathy).
Known hypersensitivity to Ferric derisomaltose/iron isomaltoside (Monoferric®) or its excipients.
Temperature >38C or patient on non-prophylactic antibiotics.
Trial design
Treatments tested in this trial
- Ferric derisomaltose
- Placebo
Treatment groups
82 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov