An Open Label Study of Intravenous Iron (FERINJECT) in Colorectal Adenocarcinoma Related Anaemia to Identify Potential Biomarkers of Responsiveness to Intravenous Iron
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Number of patients transfused allogenic red blood cells
研究概览
简要总结
20 Patients will be recruited with confirmed colorectal adenocarcinoma and anemia who are planned to undergo surgery. All patients will be treated with a single dose of 1g intravenous ferric carboxymaltose (FERINJECT).
It is hypothesized that intravenous iron supplementation is efficacious at raising haemoglobin levels and reduced blood transfusion requirements.
详细描述
Patients who are anemic at the time of operation have been shown to have an increased frequency of complications including wound infection and longer post-operative admissions. Similarly, patients who are anemic at the time of their cancer operation are more likely to require a blood transfusion which may increase the risk of recurrence of the cancer.
At present, oral iron is often used to treat anemia preoperatively in an attempt to minimize the risk above. This drug is often poorly tolerated due to the side effect profile. Blood transfusions can also be administered but expose the patient to other risks including infection and transfusion associated reactions. In order to overcome these issues, intravenous iron preparations have been developed and have improved in safety.
This is open label clinical trial, which looks to investigate the efficacy of intravenous iron is in the treatment of preoperative anemia in colorectal patients. The outcomes reviewed will include the amount and frequency of blood transfusions received, changes in patient blood profiles operative complications and hospital length of stay. The role of hepcidin as a biomarker of treatment response will also be assessed.
All data will be confidentially recorded on a Case Report Form, as will drug reactions and side effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years
- •Diagnosed with colonic or rectal adenocarcinoma
- •Defined date of operation at least 14 days from recruitment to study
- •Confirmed anemia
- •Females of child bearing age must agree to use a medically accepted form of contraceptive
排除标准
- •Patient's who are unable to consent
- •Recognized allergy or intolerance of the study drug or excipients
- •Patients with previous or current hematological disease that in the investigators' opinion would confound the diagnosis of anemia
研究组 & 干预措施
Intravenous Ferric Carboxymaltose
All recruited patients will be allocated to this treatment. 1 gram of Ferric carboxymaltose (FERINJECT) to be given at recruitment
干预措施: Intravenous ferric carboxymaltose (Drug)
结局指标
主要结局
Number of patients transfused allogenic red blood cells
时间窗: Patients will be followed from recruitment to the study until postoperative discharge from hospital, which will be an expected average of 4 weeks
To determine if the administration of intravenous iron reduces the number of expected allogenic red blood cell transfusions from recruitment to the perioperative phase
Hemoglobin levels
时间窗: Patients will be followed from recruitment to the study until 8 weeks post operatively, which will be an expected average of 10 weeks
To determine if intravenous iron significantly increases hemoglobin levels in the preoperative optimization of patients
次要结局
- Transferrin saturation levels(Patients will be followed from recruitment to the study until 8 weeks post operatively, which will be an expected average of 10 weeks)
- Ferritin levels(Patients will be followed from recruitment to the study until 8 weeks post operatively, which will be an expected average of 10 weeks)
- Hepcidin levels(Patients will be followed from recruitment to the study until the day after surgery, which will be an expected average of 3 weeks)
- Erythropoietin levels(Patients will be followed from recruitment to the study until 8 weeks post operatively, which will be an expected average of 10 weeks)
- C Reactive Protein levels(Patients will be followed from recruitment to the study until 8 weeks post operatively, which will be an expected average of 10 weeks)