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

Anemia Clinical Trial

— HepciFer  

Official title:

Hepcidin Overexpression After Hepatectomy : Does Iron Supplementation Make Sense ?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02631980
• Other study ID #: 15-079
• Status: Completed
• Phase: Phase 3
• First received: December 2, 2015
• Last updated: May 4, 2017
• Start date: October 2015
• Est. completion date: October 2016

Study information

• Verified date: May 2017
• Source: University Hospital, Geneva
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anemia
• Postoperative Blood Loss
• Postoperative Hemorrhage

Intervention

Drug:
• IV iron
Intravenous iron 15 mg/kg (max 1000 mg) in 250 ml 0.9% saline
• IV placebo
Intravenous 0.9% saline (250 ml)

Locations

Country	Name	City	State
Switzerland	University of Geneva	Geneva

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Geneva

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemoglobin level	Blood sample at postoperative Day 7	Postoperative Day 7
Secondary	Length of hospital stay		Through study completion, an average of 1 year
Secondary	Quality of life Questionnaire at day 30	Questionnaire	Postoperative Day 30