NCT04154696

Brief Summary

This study aimed to evaluate fatty liver grafts, considered as unsuitable for upfront liver transplantation, by using normothermic perfusion. Grafts have to be allocated to one of 3 liver transplantation centres of Paris. After evidence of viability while on perfusion, these grafts will be transplanted to recipients with an estimated waiting time \> 6 months.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

August 21, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

October 28, 2019

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 6, 2019

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2022

Completed
Last Updated

November 6, 2019

Status Verified

August 1, 2019

Enrollment Period

1.7 years

First QC Date

August 21, 2019

Last Update Submit

November 4, 2019

Conditions

Liver Diseases

Keywords

Steatotic liver graftLiver transplantationNormothermic perfusion

Outcome Measures

Primary Outcomes (1)

  • To determine the proportion of grafts that can be transplanted after evaluation by normothermic perfusion (Hypothesis 50%) with a 3-year graft survival ≥ 90%

    Graft survival

    3 months

Secondary Outcomes (12)

  • Proportion of hepatic grafts allocated to the 3 transplant centres of Paris and considered as initially not transplantable during the study period

    36 months

  • Proportion of fatty grafts allocated to the 3 transplant centres of Paris and considered as initially not transplantable during the study period eligible for normothermic perfusion

    36 months

  • Proportion of grafts perfused

    36 months

  • Proportion of grafts that were transplanted after perfusion

    36 months

  • Time interval until liver function recovery while on normothermic perfusion (according to viability criteria defined above)

    15 hours

  • +7 more secondary outcomes

Study Arms (1)

Normothermic perfusion of a graft

EXPERIMENTAL
Procedure: Liver transplantation of a graft after assessment by normothermic perfusion

Interventions

Liver transplantation of a graft after assessment by normothermic perfusionPROCEDURE

Liver transplantation of a graft after assessment by normothermic perfusion

Normothermic perfusion of a graft

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients enlisted for liver transplantation for liver disease or HCC (AFP score≤ 2);
  • Ongoing cotraception in women of reproductive age ;
  • Patient with social security ;
  • informed signed consent

You may not qualify if:

  • Extra-hepatic tumor disease;
  • Re-transplantation ;
  • Pregnancy or brest-feeding;
  • Patients participting in another study;
  • Patients under psychiatric treatment;
  • Patients under tutorship or curatorship

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AP-HP, Paul Brousse Hospital

Villejuif, 94800, France

Location

MeSH Terms

Conditions

Liver Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Central Study Contacts

René ADAM, Pr

CONTACT

+ 33 1 45 59 30 49rene.adam@aphp.fr

Marc-Antoine Allard, Dr

CONTACT

marcantoine.allard@aphp.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Liver transplantation of a graft after assessment by normothermic perfusion
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 21, 2019

First Posted

November 6, 2019

Study Start

October 28, 2019

Primary Completion

July 1, 2021

Study Completion

April 1, 2022

Last Updated

November 6, 2019

Record last verified: 2019-08

Locations

FR(1)