HepciFer Study: Hepcidin Overexpression After Hepatectomy : Does Iron Supplementation Make Sense ? (HepciFer)
Primary Purpose
Anemia, Postoperative Blood Loss
Status
Completed
Phase
Phase 3
Locations
Switzerland
Study Type
Interventional
Intervention
IV iron
IV placebo
Sponsored by
About this trial
This is an interventional supportive care trial for Anemia focused on measuring Hepcidin
Eligibility Criteria
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.
Sites / Locations
- University of Geneva
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
IV iron
IV placebo
Arm Description
Postoperative iv iron administration (Ferinject) upon arrival in after surgery recovery room
Postoperative iv placebo administration upon arrival in after surgery recovery room
Outcomes
Primary Outcome Measures
Hemoglobin level
Blood sample at postoperative Day 7
Secondary Outcome Measures
Length of hospital stay
Quality of life Questionnaire at day 30
Questionnaire
Full Information
NCT ID
NCT02631980
First Posted
December 2, 2015
Last Updated
May 4, 2017
Sponsor
University Hospital, Geneva
1. Study Identification
Unique Protocol Identification Number
NCT02631980
Brief Title
HepciFer Study: Hepcidin Overexpression After Hepatectomy : Does Iron Supplementation Make Sense ?
Acronym
HepciFer
Official Title
Hepcidin Overexpression After Hepatectomy : Does Iron Supplementation Make Sense ?
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
October 2015 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
October 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Geneva
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia, Postoperative Blood Loss
Keywords
Hepcidin
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IV iron
Arm Type
Experimental
Arm Description
Postoperative iv iron administration (Ferinject) upon arrival in after surgery recovery room
Arm Title
IV placebo
Arm Type
Placebo Comparator
Arm Description
Postoperative iv placebo administration upon arrival in after surgery recovery room
Intervention Type
Drug
Intervention Name(s)
IV iron
Other Intervention Name(s)
Ferinject
Intervention Description
Intravenous iron 15 mg/kg (max 1000 mg) in 250 ml 0.9% saline
Intervention Type
Drug
Intervention Name(s)
IV placebo
Other Intervention Name(s)
Placebo
Intervention Description
Intravenous 0.9% saline (250 ml)
Primary Outcome Measure Information:
Title
Hemoglobin level
Description
Blood sample at postoperative Day 7
Time Frame
Postoperative Day 7
Secondary Outcome Measure Information:
Title
Length of hospital stay
Time Frame
Through study completion, an average of 1 year
Title
Quality of life Questionnaire at day 30
Description
Questionnaire
Time Frame
Postoperative Day 30
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eduardo Schiffer, MD
Organizational Affiliation
University of Geneva
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Geneva
City
Geneva
ZIP/Postal Code
1211
Country
Switzerland
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
HepciFer Study: Hepcidin Overexpression After Hepatectomy : Does Iron Supplementation Make Sense ?
We'll reach out to this number within 24 hrs