Preoperative Intravenous Iron Therapy in Patients With Gastric Cancer
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 202
- 主要终点
- The need for blood transfusion
研究概览
简要总结
The main objective of this investigator initiated study is to study if preoperative intravenous iron is effective in reducing need for allogenic blood transfusion in patients with gastric cancer who will undergo a standardized gastrectomy including both total and subtotal gastrectomies. The hypothesis is that intravenous iron reduces the need for perioperative blood transfusions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with gastric cancer who will undergo a gastrectomy
排除标准
- •Patients under 18 years old
- •Patients not in full understanding
- •Hemoglobin levels > 155 g/l for women and >167 g/l for men (upper reference limits for the laboratory of Helsinki University Hospital district) preoperatively.
- •Transferrin saturation level >50%
- •Emergency gastrectomy
- •Palliative gastrectomy
- •Acute bacterial infection
- •Known hypersensitivity to the active substance, to ferric carboxymaltose or any of its excipients, or to other parental iron products
- •Clinical evidence of iron overload or disturbances in the utilisation of iron
- •Patients <35 kg
- •Dialysis therapy for chronic renal failure
- •Hemochromatosis
- •Polycythemia vera
- •Pregnancy
- •Patients in need of direct blood transfusion ( Criteria for this are hemoglobin < 80 g/l or < 90 g/l if the patient is symptomatic or has a history of heart disease)
研究组 & 干预措施
Intervention
IV-iron substitution: The intravenous iron formulation used in the study is ferric carboxymaltose and it will be administered two to four weeks before the surgery, aiming at four weeks. The dose of intravenous iron will be calculated according to the weight and haemoglobin level of the patients, however so that all the patients receive minimum 1000mg iv iron and the maximum dose is 20 mg/kg per day.
干预措施: Ferric carboxymaltose (Drug)
Placebo
Placebo is NaCl 0.9% solution, which is administrated in the same way as the study drug
干预措施: Placebos (Drug)
结局指标
主要结局
The need for blood transfusion
时间窗: Within 30 days from the day of the operation
Number of patients needing transfusions
次要结局
- Patients' quality of life (15D)(One and six months after the surgery)
- Patients' quality of life (EQ-5D)(One and six months after the surgery)
- Patients' quality of life (FRAIL)(One and six months after the surgery)
- Patients' quality of life (PRISMA-7)(One and six months after the surgery)
- Re-admission(30 days after discharge from hospital)
- Patients' quality of life (RAND)(One and six months after the surgery)
- Postoperative complications(Within 30 days from operation)
- 90-day mortality(Within 90 days from operation)
- Overall survival(1, 3 and 5 years from operation)
- Length of hospital stay(Within hospital stay, on average 7 - 14 days)
- Use of IV iron after operation(Within 3 months from operation)
- Patients' haemoglobin and iron parameter levels(Three months after the surgery)
- Patients' quality of life (GSRS)(One and six months after the surgery)
- Patients' quality of life (IDQ)(One and six months after the surgery)
研究者
Ville Sallinen
MD, Phd, Adj. Professor
Helsinki University Central Hospital