NCT02460250

Brief Summary

According to the French Biomedicine Agency annual report on retrieval activities and transplants, 1,164 liver transplants were performed in 2011 and 1,161 in 2012. If the amount of brain death donors and retrieved liver grafts appears relatively stable, it remains clearly insufficient compared to the increasing number of patients on the waiting list for liver transplantation (2,462 in 2011). The median time on the waiting list before liver transplantation which was established from the cohort of patients registered between 2007 and 2011 (excluding patients registered for emergency transplantation and for living related-donor transplantation) increased significantly from 4.4 months between 2007 and 2009 to 6.6 months between 2010 and 2011. In order to compensate for the lack of liver grafts, donors acceptance criteria were broadened. For example, alternative transplantation lists were created with liver grafts coming from so-called "marginal" donors. However, despite these efforts, livers were retrieved on only two out of three brain death donors, i.e. in 1,572 and 1,589 organ donors in 2011 and 2012, respectively. This is unfortunately not enough to meet the increasing needs in liver grafts and a growing number of patients wait each year for transplant. Strategic lines of improvement were defined in order to meet the "2012-2016 transplant perspective" which targets 5,700 transplants carried out in 2015 (+5% every year, all transplants included, with 5,023 transplants in 2012). According to the last consensus conference on liver transplantation of the HAS (French High Authority of Health) the assessment of the degree of macrovacuolar and microvacuolar steatosis determines the possibility to retrieve the graft or not. Liver steatosis consists in an accumulation of fatty droplets in hepatocytes. Its prevalence is high, ranging from 16% to 31% in the general population, and increases up to 46% in heavy drinkers and to 50-80% in the obese population. Steatosis results mostly from alcohol consumption and from metabolic syndrome (obesity, type 2 diabetes, hypertriglyceridemia) called non-alcoholic fatty liver disease (NAFLD), and is more rarely secondary to viral hepatitis or exposure to certain medications. NAFLD involves up to 30% of the population in Western countries and its prevalence is increasing. NAFLD may lead to asymptomatic steatosis, but also to steatohepatitis or advanced fibrosis including cirrhosis and its complications Accordingly, the improvement of liver grafts selection based on objective quantitative criteria which takes into account the degree of liver steatosis appears crucial to increase the number of hepatic transplants.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
740

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

19 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 13, 2015

Completed
20 days until next milestone

First Posted

Study publicly available on registry

June 2, 2015

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 9, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 9, 2018

Completed
Last Updated

October 24, 2019

Status Verified

October 1, 2019

Enrollment Period

2.8 years

First QC Date

May 13, 2015

Last Update Submit

October 23, 2019

Conditions

Tissue and Organ HarvestingLiver TransplantationBrain Death

Keywords

Tissue and Organ HarvestingLiver graftBrain DeathFibroScan®

Outcome Measures

Primary Outcomes (1)

  • Controlled Attenuation Parameter™ (CAP™) measurement

    Evaluation of the diagnostic accuracy of the CAP™ measured with Fibroscan® to objectively reflect the degree of liver steatosis, a parameter which can be used as an aid in selecting liver grafts before retrieval in donors with brain death (DBD).

    1 Day

Secondary Outcomes (13)

  • Liver Stiffness (LS) measurement

    1 Day

  • Controlled Attenuation Parameter™ (CAP™) measurement

    1 week

  • Liver Stiffness (LS) measurement

    1 week

  • Liver Stiffness (LS) measurement

    1 month

  • Controlled Attenuation Parameter™ (CAP™) measurement

    1 month

  • +8 more secondary outcomes

Study Arms (1)

Fibroscan

EXPERIMENTAL

All included patients will undergo a Fibroscan (either Fibroscan Touch model or 402 model which enable CAPTM data extraction) once all eligibility criteria have been checked. Liver recipients will be followed up during one year. Biological and medical data used by all transplant sites for the follow-up of transplant patient will be collected

Procedure: Fibroscan

Interventions

FibroscanPROCEDURE

All included patients will undergo a Fibroscan (either Fibroscan Touch model or 402 model which enable CAPTM data extraction) once all eligibility criteria have been checked.

Fibroscan

Eligibility Criteria

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

You may qualify if:

  • Patients older than 18 years with recognized clinical brain death confirmed by clinical examination, who are considered for organ retrieval and clinically stable to achieve the retrieval procedure

You may not qualify if:

  • Personal objection to organ retrieval and clinical research expressed during lifetime and registered in the Registre National des Refus (French registration of all refusals to organ donation)
  • Family objection to liver retrieval after donor's death
  • Ongoing pregnancy when brain death is declared

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

University Hospital

Amiens, 80054, France

Location

University Hospital

Angers, 49100, France

Location

University Hospital

Besançon, 25030, France

Location

University Hospital

Bordeaux, 33000, France

Location

University Hospital

Brest, 29200, France

Location

University Hospital

Caen, 14033, France

Location

Estaing University Hospital

Clermont-Ferrand, 63100, France

Location

AP-HP Henri MONDOR

Créteil, 94010, France

Location

University Hospital

Grenoble, 38043, France

Location

University Hospital

Lille, 59037, France

Location

University Hospital

Limoges, 87042, France

Location

Croix Rousse Hospital

Lyon, 69004, France

Location

Nice University Hospital

Nice, 06000, France

Location

AP-HP Kremlin Bicêtre

Paris, 84270, France

Location

University Hospital

Poitiers, 86021, France

Location

Univesity Hospital

Reims, 51100, France

Location

University Hospital

Rennes, 35033, France

Location

University Hospital

Tours, 37044, France

Location

University Hospital

Vandœuvre-lès-Nancy, 54500, France

Location

MeSH Terms

Conditions

Brain Death

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesComaUnconsciousnessConsciousness DisordersNeurobehavioral ManifestationsNeurologic ManifestationsDeathPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Nicolas PICHON, MD

    University Hospital, Limoges

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 13, 2015

First Posted

June 2, 2015

Study Start

February 1, 2015

Primary Completion

November 9, 2017

Study Completion

November 9, 2018

Last Updated

October 24, 2019

Record last verified: 2019-10

Locations

FR(19)