Clinical trial NCT02631980: HepciFer Study: Hepcidin Overexpression After Hepatectomy : Does Iron Supplementation Make Sense ?
Official title: Hepcidin Overexpression After Hepatectomy : Does Iron Supplementation Make Sense ?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anemia
Postoperative Blood Loss
Keywords: Hepcidin
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2015-12-16
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Hemoglobin level
timeFrame: Postoperative Day 7
Secondary outcomes:
measure: Length of hospital stay
timeFrame: Through study completion, an average of 1 year
measure: Quality of life Questionnaire at day 30
timeFrame: Postoperative Day 30
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: University of Geneva
Study officials:
affiliation: University of Geneva
name: Eduardo Schiffer, MD
role: PRINCIPAL_INVESTIGATOR
References: