Hepcidin Overexpression After Hepatectomy : Does Iron Supplementation Make Sense ?
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
- 是
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
Postoperative iv iron administration (Ferinject) upon arrival in after surgery recovery room
干预措施: IV iron (Drug)
IV placebo
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
Eduardo Schiffer
M.D.
University Hospital, Geneva
