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

Phase 3

Completed

• Conditions: Anemia; Postoperative Blood Loss
• Interventions: Drug: IV placebo; Drug: IV iron

• Registration Number: NCT02631980
• Lead Sponsor: University Hospital, Geneva

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.

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2015-12-02
• Study First Submitted QC: 2015-12-11
• Study First Posted: 2015-12-16
• Primary Completion: 2016-10
• Study Completion: 2016-10
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-04
• Last Update Posted: 2017-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IV placebo	IV placebo	Postoperative iv placebo administration upon arrival in after surgery recovery room
IV iron	IV iron	Postoperative iv iron administration (Ferinject) upon arrival in after surgery recovery room

Primary Outcome Measures

Name	Time	Method
Hemoglobin level	Postoperative Day 7	Blood sample at postoperative Day 7

Secondary Outcome Measures

Name	Time	Method
Length of hospital stay	Through study completion, an average of 1 year
Quality of life Questionnaire at day 30	Postoperative Day 30	Questionnaire

Trial Locations

Locations (1)

University of Geneva; 🇨🇭 Geneva, Switzerland