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临床试验/NCT04168346
NCT04168346尚未招募4 期

Preoperative Intravenous Iron Therapy in Patients With Gastric Cancer

Helsinki University Central Hospital0 个研究点目标入组 202 人开始时间: 2019年11月最近更新:
适应症
干预措施
相关药物

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

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

Experimental

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 Comparator

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ville Sallinen

MD, Phd, Adj. Professor

Helsinki University Central Hospital

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