NCT02631980

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Oct 2015

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 2, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 16, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

May 5, 2017

Status Verified

May 1, 2017

Enrollment Period

1 year

First QC Date

December 2, 2015

Last Update Submit

May 4, 2017

Conditions

AnemiaPostoperative Blood Loss

Keywords

Hepcidin

Outcome Measures

Primary Outcomes (1)

  • Hemoglobin level

    Blood sample at postoperative Day 7

    Postoperative Day 7

Secondary Outcomes (2)

  • Length of hospital stay

    Through study completion, an average of 1 year

  • Quality of life Questionnaire at day 30

    Postoperative Day 30

Study Arms (2)

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

IV ironDRUG

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

Also known as: Ferinject
IV iron
IV placeboDRUG

Intravenous 0.9% saline (250 ml)

Also known as: Placebo
IV placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Scheduled liver surgery,
  • Liver resection \> 2 segments.

You may not qualify if:

  • Age below 18yrs,
  • Pregnancy,
  • Emergent surgery,
  • Sepsis,
  • Immunosuppressive therapy,
  • Renal insufficiency (GFR\<30ml/min/m2),
  • Hypersensitivity to iron,
  • Iron overload.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Geneva

Geneva, 1211, Switzerland

Location

MeSH Terms

Conditions

AnemiaPostoperative Hemorrhage

Interventions

ferryl ironferric carboxymaltose

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsPostoperative Complications

Study Officials

  • Eduardo Schiffer, MD

    University of Geneva

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

December 2, 2015

First Posted

December 16, 2015

Study Start

October 1, 2015

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

May 5, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)