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

University Hospitals (UH)

Status and phase: Completed; Phase 3

Conditions: Anemia; Postoperative Blood Loss

Treatments: Drug: IV iron; Drug: IV placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02631980

15-079

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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50 participants in 2 patient groups, including a placebo group

IV iron

Experimental group

Description:

Postoperative iv iron administration (Ferinject) upon arrival in after surgery recovery room

Treatment:

Drug: IV iron

IV placebo

Placebo Comparator group

Description:

Postoperative iv placebo administration upon arrival in after surgery recovery room

Treatment:

Drug: IV placebo