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NCT Number: NCT02631980

HepciFer Study: Hepcidin Overexpression After Hepatectomy : Does Iron Supplementation Make Sense ?

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Geneva

Geneva, 1211, Switzerland

About this study

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.

This is a monocentric, randomized, double blinded and placebo controlled trial. Iron iv injection will be administered postoperatively. Hematology assessments, biological iron deficiency, inflammation and coagulation will be realized pre and postoperatively. Hepcidin is assayed by an ELISA method.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

IV iron

Drug

Intravenous iron 15 mg/kg (max 1000 mg) in 250 ml 0.9% saline

Other names: Ferinject

IV Placebo

Drug

Intravenous 0.9% saline (250 ml)

Other names: Placebo

Primary outcomes

  1. Hemoglobin level

    Time frame: Postoperative Day 7

    Blood sample at postoperative Day 7

Secondary outcomes

  1. Length of hospital stay

    Time frame: Through study completion, an average of 1 year

  2. Quality of life Questionnaire at day 30

    Time frame: Postoperative Day 30

    Questionnaire

Sponsors and collaborators

Lead sponsor

University Hospital, Geneva

Other

Registry information

Official study title

Hepcidin Overexpression After Hepatectomy : Does Iron Supplementation Make Sense ?

Acronym: HepciFer

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Dec 16, 2015
Registry last updated
May 5, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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