NCT03858088

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,350

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2018

Shorter than P25 for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 15, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 28, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 27, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 28, 2019

Completed
Last Updated

March 1, 2019

Status Verified

February 1, 2019

Enrollment Period

6 months

First QC Date

February 27, 2019

Last Update Submit

February 28, 2019

Conditions

Liver Transplant Failure

Keywords

liver transplantallograft failureprimary dysfunctionearly outcomesurvival analysisprimary non-functionretransplant

Outcome Measures

Primary Outcomes (1)

  • Early Allograft Failure

    Graft loss after liver transplantation

    90 days

Secondary Outcomes (1)

  • Early Allograft Failure

    30 days

Study Arms (2)

Training set

Cohort of consecutive liver transplants performed in 2016-2017 from 14 liver transplant centers in Italy

Procedure: Liver transplantation

Validation set

Cohort of consecutive liver transplants performed in 2016-2017 from 2 liver transplant centers in the United Kingdom

Procedure: Liver transplantation

Interventions

Liver transplantationPROCEDURE

Liver transplantation from deceased donors

Training setValidation set

Eligibility Criteria

Age18 Years - 73 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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).

You may qualify if:

  • Primary liver transplants from deceased donors

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione Policlinico Universitario A. Gemelli, IRCCS

Roma, 00168, Italy

Location

Related Publications (1)

  • Agopian VG, Harlander-Locke MP, Markovic D, Dumronggittigule W, Xia V, Kaldas FM, Zarrinpar A, Yersiz H, Farmer DG, Hiatt JR, Busuttil RW. Evaluation of Early Allograft Function Using the Liver Graft Assessment Following Transplantation Risk Score Model. JAMA Surg. 2018 May 1;153(5):436-444. doi: 10.1001/jamasurg.2017.5040.

    PMID: 29261831BACKGROUND

MeSH Terms

Interventions

Liver Transplantation

Intervention Hierarchy (Ancestors)

Tissue TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsDigestive System Surgical ProceduresSurgical Procedures, OperativeOrgan TransplantationTransplantation

Study Officials

  • Alfonso W Avolio, MD

    alfonso.avolio@unicatt.it

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 27, 2019

First Posted

February 28, 2019

Study Start

June 15, 2018

Primary Completion

November 28, 2018

Study Completion

January 10, 2019

Last Updated

March 1, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)