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

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.

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Key information

Conditions

Rejection Acute Hepatic Digestive System Diseases Liver Diseases Liver Dysfunction Transplant; Failure, Liver

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondazione Policlinico Universitario A. Gemelli IRCCS

Rome, 00181, Italy

Location status: Recruiting

Location contact

Antonio Liguori, MD

CONTACT

[email protected]

+390630159223

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Early Allograft dysfunction (EAD)

Time frame: 2 weeks from Liver transplantation

Olthoff criteria: bilirubina≥ 10 mg/dL in 7th post-operative day, international normalized ratio (INR) ≥ 1.6 in 7th post-operative day 7; ALT or AST> 2000 IU/L during the first 7 days after liver transplantation

Study contacts

Contact information is provided by the study sponsor or research team.

Luca Miele, MD, PhD

CONTACT

[email protected]

+390630151

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Acronym: ElastOLT

Important dates

Study start: 2020
Primary completion: 2026
Study completion: 2027
First posted: Mar 31, 2023
Registry last updated: Mar 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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