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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Hepcidin Overexpression After Hepatectomy : Does Iron Supplementation Make Sense ?

Conditions
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Anemia, Postoperative Blood Loss

Intervention / Treatment
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* Drug: IV iron
* Drug: IV placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepcidin