Early Allograft Failure Simplified Estimation (EASE) in Liver Transplantation (EASE)

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ClinicalTrials.gov Identifier: NCT03858088

Recruitment Status : Completed

First Posted : February 28, 2019

Last Update Posted : March 1, 2019

Sponsor:

Collaborators:

Azienda Ospedaliero, Universitaria Pisana

The Mediterranean Institute for Transplantation and Advanced Specialized Therapies

University Hospital Padova

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

A.O. Ospedale Papa Giovanni XXIII

Ospedali Riuniti Ancona

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Azienda Ospedaliero-Universitaria di Modena

University of Roma La Sapienza

Azienda Ospedaliera Universitaria Integrata Verona

Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi

Azienda Ospedaliera Niguarda Cà Granda

Azienda Ospedaliera Città della Salute e della Scienza di Torino

University Hospital Birmingham NHS Foundation Trust

Newcastle-upon-Tyne Hospitals NHS Trust

Information provided by (Responsible Party):

Prof. Alfonso Avolio, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Study Description

Brief Summary:

A variety of clinical scores have been developed with the intent to predict early allograft failure after liver transplantation. With the present study the investigators aim to validate the recently published L-GrAFT Score on a multicenter cohort from 14 liver transplant centers in Italy.

Secondly, after identifying coefficients which are peculiar for the Italian transplant population, the investigators aim to develop a novel, simplified model for the estimation of early allograft failure (EASE Score).

Thirdly, the investigators plan to validate the EASE Score on a population from two liver transplant centers in the United Kingdom.

Condition or disease	Intervention/treatment
Liver Transplant Failure	Procedure: Liver transplantation

Detailed Description:

Liver transplantation (LT) is the gold standard treatment for end-stage liver disease. The broadening of indications has caused a growing gap between patients on the waiting list and those who receive a transplant with the consequence of patients still dying while awaiting to be transplanted.

This phenomenon has led the transplant community to expand the donors pool, thus including organs with a higher risk profile. The so called marginal organs carry a higher risk of failure especially in the early post-transplant phase. Early allograft failure (EAF) is known as a poor prognostic factor for patient survival.Treatment of graft failure is based on re-transplantation (Re-LT).

However, there are no clear-cut clinical/biochemical parameters to base the decision of Re-LT on. In addition, to which extent EAF is irreversible is not entirely predictable. Such prediction has been the objective of extensive research and debate as it can guide the physicians through the decision whether or not re-transplanting a recipient of a failing graft.

The availability of an easy algorithm to quickly identify the cases who are irreversibly heading towards graft failure and need re-LT is highly desirable.

Various definitions of EAF have been introduced but they all share the same limitation of being based on a dichotomous evaluation of biochemical parameters (e.g. AST, INR, bilirubin, etc. below or above a certain cut-off level).

Recently, a new score has been developed with the aim of overcoming this limitation: the Liver Graft Assessment Following Transplantation (L-GrAFT). This score not only provides a tool to diagnose EAF but also assesses the severity and the evolution of EAF using the kinetics of a set of biochemical parameters. However, L-GrAFT is predictive of EAF at 90 days, is based on 31 biochemical determinations and has not been validated in a multicenter setting.

With the present study the investigators aim:

to evaluate the performance of the L-GrAFT score and its ability to predict graft loss in the early post-operative phase (i.e. 90 days after LT) in a cohort of patients who received a primary LT from 2016 to 2017 in one of 14 LT Centers based in Italy, analyzing their prospectively maintained databases with a minimum follow up of 6 months;
to develop a simplified algorithm, derived from the L-GrAFT algorithm, based on the Italian LT population, reducing the number of determinations allowing an easier data entry, which is predictive of EAF at 90 (90dEASE Score) and also at 30 days post LT (30dEASE Score);
to validate the EASE scores on a population internal to the Italian database, using bootstrap methodology;
to validate the EASE scores on an external UK liver transplant Cohort. The investigators are planning to present the results of the study in international congresses and meetings and after that to produce a manuscript.

Study Design

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Study Type :	Observational
Actual Enrollment :	2350 participants
Observational Model:	Cohort
Time Perspective:	Retrospective
Official Title:	Early Allograft Failure Simplified Estimation (EASE). A Novel Predictive Model for Estimating Early Allograft Failure in Liver Transplantation: a Multicenter Italian Study With a UK Validation Cohort.
Actual Study Start Date :	June 15, 2018
Actual Primary Completion Date :	November 28, 2018
Actual Study Completion Date :	January 10, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Transplantation

U.S. FDA Resources

Groups and Cohorts

Group/Cohort	Intervention/treatment
Training set Cohort of consecutive liver transplants performed in 2016-2017 from 14 liver transplant centers in Italy	Procedure: Liver transplantation Liver transplantation from deceased donors
Validation set Cohort of consecutive liver transplants performed in 2016-2017 from 2 liver transplant centers in the United Kingdom	Procedure: Liver transplantation Liver transplantation from deceased donors

Outcome Measures

Primary Outcome Measures :

Early Allograft Failure [ Time Frame: 90 days ]
Graft loss after liver transplantation

Secondary Outcome Measures :

Early Allograft Failure [ Time Frame: 30 days ]
Graft loss after liver transplantation

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 73 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

A total of 1800 recipients of a primary liver transplant (LT) from 14 LT Centers from Italy (Training set) and 550 recipients of LT from 2 LT Centers from the United Kingdom (Validation set).

Criteria

Inclusion Criteria:

Primary liver transplants from deceased donors

Exclusion Criteria:

combined transplants (liver transplanted simultaneously with another organ transplant)
living donor liver transplant
domino liver transplant
pediatric transplants
HIV+ recipients

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03858088

Locations

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Italy
Fondazione Policlinico Universitario A. Gemelli, IRCCS
Roma, Italy, 00168

Sponsors and Collaborators

Fondazione Policlinico Universitario Agostino Gemelli IRCCS