临床试验/2024-519738-21-01

2024-519738-21-01招募中4 期

Preoperative intravenous iron therapy in patients with gastric cancer

HUS-Yhtymae1 个研究点分布在 1 个国家目标入组 202 人开始时间: 2024年12月16日最近更新: 2024年12月16日

试验速览

阶段: 4 期
状态: 招募中
发起方
入组人数: 202
试验地点: 1
主要终点: Number of patients receiving transfusions

研究概览入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

TO investigate if preoperative iron infusion decreases the risk of transfusions and complications in after operation for gastric cancer.

入排标准

年龄范围: 18 years 至 65+ years（18-64 Years, 65+ Years）
接受健康志愿者: 否

入选标准

•Adult patients with gastric cancer

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 Polycytemia vera Pregnancy Patients in need of direct blood transfusion

结局指标

主要结局

Number of patients receiving transfusions

次要结局

Postoperative Hb level, complications and quality of life

研究者

发起方

HUS-Yhtymae

申办方类型

Hospital/Clinic/Other health care facility

责任方

Principal Investigator

主要研究者

Arto Kokkola

Scientific

HUS-Yhtymae

研究点 (1)

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