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Single-center Prospective Study of Non-invasive Methods for the Diagnosis of Postoperative Complications in Liver Transplant Recipients

NCT ID: NCT05793203

Last Updated: 2023-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-06

Study Completion Date

2027-12-31

Brief Summary

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A lot of different early and late complications may occur after liver transplantation. They could be related to surgical procedure, to infectious diseases or immuno-mediated diseases (acute cellular rejection, ACR). Almost all of those complications are characterized by an elevation in liver enzymes (ALT, AST and GGT) and a decline of liver function tests (serum bilirubin and INR increase) possibly leading to early allograft disfunction (EAD). In this scenario there is a lack of biomarker that could predict the development of ACR and/or EAD.

The aim of this study is to explore the prognostic role of non-invasive instrumental and biological marker in the early post-transplant phase.

Detailed Description

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Conditions

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Rejection Acute Hepatic Transplant; Failure, Liver Liver Dysfunction

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Patients eligible for liver transplantation following National and International Guidelines

Exclusion Criteria

* No agreement or inability to give informed consent

* Re-transplant patients
* Liver transplant in fulminant hepatitis
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Antonio Liguori, MD

Role: STUDY_CHAIR

Catholic University of the Sacred Heart

Locations

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Fondazione Policlinico Universitario A. Gemelli IRCCS

Rome, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Luca Miele, MD, PhD

Role: CONTACT

Phone: +390630151

Email: [email protected]

Facility Contacts

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Antonio Liguori, MD

Role: primary

Other Identifiers

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4176

Identifier Type: -

Identifier Source: org_study_id