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临床试验/NCT02631980
NCT02631980已完成3 期

Hepcidin Overexpression After Hepatectomy : Does Iron Supplementation Make Sense ?

University Hospital, Geneva1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2015年10月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
50
试验地点
1
主要终点
Hemoglobin level

研究概览

简要总结

Hepcifer Trial is designed to assess the value of iv iron administration immediately after liver surgery and consequences of inflammation on iron balance. Fifty patients will be randomized in two treatment groups. Patients will be assigned to receive either iv iron or placebo immediately after liver resection surgery. Biological inflammation parameters, hemoglobin, serum iron and hepcidin levels will be assessed prior to surgery and at day 1, 3, 7, 15 and 30 after surgery.

详细描述

The iron homeostasis is now well known. Indeed, the discovery of hepcidin, a protein synthesized by the liver, has provided a better understanding of iron metabolism and the resulting anemia disruption of this homeostasis.

Although morbidity decreased hepatic surgery remains a major surgery as by surgical difficulty by support intra- and postoperatively.

A preliminary study, the investigators found that patients had preoperative anemia (oncological context) increased postoperatively, increasing the morbidity.

Few clinical studies on hepcidin and anemia were carried out, because of the difficulty of metering (mass spectrometry) as well as its cost.

In this clinical trial, the investigators plan to assess the value of iv iron administration versus iv placebo treatment immediately after liver surgery and consequences of inflammation on iron balance. In addition, an evaluation of the well being of patients will be performed postoperatively to measure the functional and psychological impact of anemia.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Triple (Participant, Care Provider, Investigator)

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

  • Scheduled liver surgery,
  • Liver resection > 2 segments.

排除标准

  • Age below 18yrs,
  • Pregnancy,
  • Emergent surgery,
  • Immunosuppressive therapy,
  • Renal insufficiency (GFR<30ml/min/m2),
  • Hypersensitivity to iron,
  • Iron overload.

研究组 & 干预措施

IV iron

Experimental

Postoperative iv iron administration (Ferinject) upon arrival in after surgery recovery room

干预措施: IV iron (Drug)

IV placebo

Placebo Comparator

Postoperative iv placebo administration upon arrival in after surgery recovery room

干预措施: IV placebo (Drug)

结局指标

主要结局

Hemoglobin level

时间窗: Postoperative Day 7

Blood sample at postoperative Day 7

次要结局

  • Length of hospital stay(Through study completion, an average of 1 year)
  • Quality of life Questionnaire at day 30(Postoperative Day 30)

研究者

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

Eduardo Schiffer

M.D.

University Hospital, Geneva

研究点 (1)

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