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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Ferric derisomaltose
DrugFerric 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
DrugPatients randomized to the Placebo arm will receive 100mg of normal saline over 1 hour.
Treatment groups
82 Participants
are divided into 2 treatment groupsGroup A: Iron Therapy ArmExperimental treatment 1 intervention
Group B: Placebo ArmPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Mean preoperative haemoglobin concentration
To determine the effect of IV iron supplementation provided at least 21 days prior to surgery for gynecologic malignancy on mean preoperative haemoglobin concentration (in g/L)in patients with iron deficiency anemia compared to those patients without preoperative IV iron supplementation.
Time frame
Haemoglobin concentration will be measured at baseline and 3 days prior to surgery after treatment with Ferric DerisomaltoseSecondary outcomes
1
Mean haemoglobin concentration at the time of surgery
The effect of IV iron supplementation provided prior to surgery for gynecologic malignancy on mean haemoglobin concentration (in g/L) at the time of surgery.
Time frame
Haemoglobin concentration will be measured at baseline and at the time of surgery after treatment with Ferric Derisomaltose2
Mean postoperative haemoglobin concentration
The effect of IV iron supplementation provided prior to surgery for gynecologic malignancy on mean hemoglobin concentration after the completion of surgery which will be assessed by measuring blood hemoglobin levels
Time frame
Haemoglobin concentration will be measured at 28 and 60 days after surgery3
Assessment of the requirement of postoperative blood transfusion
The number of participants requiring blood transfusion after completion of gynecologic surgery. A blood transfusion event is defined as receiving any volume of one unit or more than one unit of packed red cells or whole blood.
Time frame
Day 0 to 28 days following surgery4
Mean number of blood transfusions
The mean number of blood transfusion (total number of units of packed red blood cells transfused ) after completion of gynecologic surgery
Time frame
Day 0 to 28 days following surgerySponsors and contacts
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Source ClinicalTrials.gov