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
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- Mean preoperative haemoglobin concentration
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Signed written informed consent prior to initiation of any study specific activities/procedures.
- •Age ≥ 18 years old.
- •Patients undergoing elective major surgery on the gynecologic oncology service with the following criteria will be considered for inclusion:
- •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
- •The expected time from recruitment to surgery is 28-90 days.
- •Screening haemoglobin less than 120 g/L and transferrin saturation (TSAT) <20%.
- •Randomization and administration of study infusion a minimum of 21 days and maximum 90 days before planned operation.
- •Negative pregnancy test for women of childbearing potential (WOCBP) (within 7 days prior to treatment).
- •WOCBP must adhere to the contraception requirement from screening throughout the study period until 6 weeks post treatment.
- •Laboratory data used for determination of eligibility (Hemoglobin and Transferrin saturation) at the baseline visit must not be older than 4 weeks.
排除标准
- •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.
- •Known chronic liver disease or active hepatitis.
- •Received erythropoietin or IV iron therapy within previous 12 weeks prior to planned study drug treatment.
- •Alanine transaminase (ALT) or aspartate transaminase (AST) above three times the upper limit of normal (ULN) range.
- •Immunosuppressive therapy (for solid organ transplant), or renal dialysis (current, or planned within next 12 months following treatment with study drug or placebo).
- •Unfit for elective surgery.
- •Pregnancy or lactation.
- •Unable to fully comprehend and/or perform study procedures and patients with psychiatric illness/social situations/substance abuse that would limit compliance with study requirements.
- •Cervical cancer with a clinical stage of 2A or greater.
研究组 & 干预措施
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.
干预措施: Ferric derisomaltose (Drug)
Placebo Arm
100mL of normal saline will be administered intravenously over 1 hour between 21 and 90 days preceding surgical intervention.
干预措施: Placebo (Drug)
结局指标
主要结局
Mean preoperative haemoglobin concentration
时间窗: Haemoglobin concentration will be measured at baseline and 3 days prior to surgery after treatment with Ferric Derisomaltose
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.
次要结局
- Mean postoperative haemoglobin concentration(Haemoglobin concentration will be measured at 28 and 60 days after surgery)
- Assessment of the requirement of postoperative blood transfusion(Day 0 to 28 days following surgery)
- Mean Change in the Functional Assessment of Cancer Therapy-Anemia (FACT-An) Scores(Baseline to 0-3 days prior to surgery and at 23-33 days postoperative)
- Mean haemoglobin concentration at the time of surgery(Haemoglobin concentration will be measured at baseline and at the time of surgery after treatment with Ferric Derisomaltose)
- Mean number of blood transfusions(Day 0 to 28 days following surgery)
- Postoperative Quality of Recovery(QoR)-15 questionnaire score(Post-operation day 1 (24 hours ± 12 hours following surgery))
- Mean Change in Quality of life measured with the EQ5D5L (European Quality of Life Five Dimension) scores(Baseline to 0-3 days prior to surgery and at 23-33 days postoperative)
- Postoperative length of hospital stay(From Surgery date up to 60 days post surgery)
- Mean Change in Quality of life measured with the SF-36 scores(Baseline to 0-3 days prior to surgery and at 23-33 days postoperative)
- Clinical surgical site infection(within 28 days following surgery)
- Clinical surgical complications(within 28 days following surgery)
- Rate of hospital readmission(from discharge date to 28 days post surgery)