HepciFer Study: Hepcidin Overexpression After Hepatectomy... | NCT02631980

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

NCT02631980

Sponsor

University Hospital, Geneva

Status

Completed

Last Update Posted

May 5, 2017Actual

Enrollment

50Actual

Phase

Phase 3

Conditions

Anemia
Postoperative Blood Loss

Interventions

IV iron
IV placebo

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2015

Primary Completion Date

Oct 2016Actual

Completion Date

Oct 2016Actual

First Submitted Date

Dec 2, 2015

First Submission Date that Met QC Criteria

Dec 11, 2015

First Posted Date

Dec 16, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 4, 2017

Last Update Posted Date

May 5, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Eduardo Schiffer, M.D., University Hospital, GenevaPrincipal Investigator

Lead Sponsor

University Hospital, GenevaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
IV iron	Experimental	Postoperative iv iron administration (Ferinject) upon arrival in after surgery recovery room	Drug: IV iron
IV placebo	Placebo Comparator	Postoperative iv placebo administration upon arrival in after surgery recovery room	Drug: IV placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
IV iron	Drug	Intravenous iron 15 mg/kg (max 1000 mg) in 250 ml 0.9% saline	IV iron

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Hemoglobin level	Blood sample at postoperative Day 7	Postoperative Day 7

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Eduardo Schiffer, MD	University of Geneva, Switzerland	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Geneva		Geneva		1211	Switzerland

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000740	Anemia
D019106	Postoperative Hemorrhage

Ancestor Terms

ID	Term
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases
D006470	Hemorrhage
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C066317	ferryl iron
C522335	ferric carboxymaltose

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided