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

Recruiting

• Conditions: Transplant; Failure, Liver; Rejection Acute Hepatic; Liver Dysfunction

• Registration Number: NCT05793203
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Brief Summary

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

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2020-07-06
• Status Verified: 2023-02
• Study First Submitted: 2023-03-20
• Study First Submitted QC: 2023-03-20
• Last Update Submitted: 2023-03-20
• Study First Posted: 2023-03-31
• Last Update Posted: 2023-03-31
• Primary Completion: 2026-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Patients eligible for liver transplantation following National and International Guidelines

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Exclusion Criteria

• No agreement or inability to give informed consent

  • Re-transplant patients
  • Liver transplant in fulminant hepatitis

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Early Allograft dysfunction (EAD)	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

Trial Locations

Locations (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS; 🇮🇹 Rome, Italy