NCT02631980

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

Hepcidin Overexpression After Hepatectomy : Does Iron Supplementation Make Sense ?

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: University Hospital, Geneva · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Anemia
• Postoperative Blood Loss

Interventions

Type	Name	Description
DRUG	IV iron	Intravenous iron 15 mg/kg (max 1000 mg) in 250 ml 0.9% saline
DRUG	IV placebo	Intravenous 0.9% saline (250 ml)

Timeline

• Start date: 2015-10-01
• Primary completion: 2016-10-01
• Completion: 2016-10-01
• First posted: 2015-12-16
• Last updated: 2017-05-05

Locations

1 site across 1 country: Switzerland