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

Hepcidin Overexpression After Hepatectomy : Does Iron Supplementation Make Sense ?

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02631980
Acronym
HepciFer
Enrollment
50
Registered
2015-12-16
Start date
2015-10-31
Completion date
2016-10-31
Last updated
2017-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anemia, Postoperative Blood Loss

Keywords

Hepcidin

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.

Interventions

Intravenous iron 15 mg/kg (max 1000 mg) in 250 ml 0.9% saline

DRUGIV placebo

Intravenous 0.9% saline (250 ml)

Sponsors

University Hospital, Geneva
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Hemoglobin levelPostoperative Day 7Blood sample at postoperative Day 7

Secondary

MeasureTime frameDescription
Length of hospital stayThrough study completion, an average of 1 year
Quality of life Questionnaire at day 30Postoperative Day 30Questionnaire

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026