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

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.

Study Overview

• Status: Completed
• Conditions: Anemia; Postoperative Blood Loss
• Intervention / Treatment: Drug: IV iron; Drug: IV placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 3

Contacts and Locations

Study Locations

• Switzerland
  • Geneva, Switzerland, 1211
    • University of Geneva

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IV iron; Postoperative iv iron administration (Ferinject) upon arrival in after surgery recovery room	Drug: IV iron; Intravenous iron 15 mg/kg (max 1000 mg) in 250 ml 0.9% saline; Other Names: Ferinject
Placebo Comparator: IV placebo; Postoperative iv placebo administration upon arrival in after surgery recovery room	Drug: IV placebo; Intravenous 0.9% saline (250 ml); Other Names: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemoglobin level	Blood sample at postoperative Day 7	Postoperative Day 7

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of hospital stay		Through study completion, an average of 1 year
Quality of life Questionnaire at day 30	Questionnaire	Postoperative Day 30

Collaborators and Investigators

• Sponsor: University Hospital, Geneva
• Investigators: Principal Investigator: Eduardo Schiffer, MD, University of Geneva

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Actual): October 1, 2016
• Study Completion (Actual): October 1, 2016

Study Registration Dates

• First Submitted: December 2, 2015
• First Submitted That Met QC Criteria: December 11, 2015
• First Posted (Estimate): December 16, 2015

Study Record Updates

• Last Update Posted (Actual): May 5, 2017
• Last Update Submitted That Met QC Criteria: May 4, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Hepcidin
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Hemorrhage; Postoperative Hemorrhage
• Other Study ID Numbers: 15-079

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO