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

NCT05793203 | Recruiting

• 1 other identifier: 4176
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Rejection Acute Hepatic; Transplant; Failure, Liver; Liver Dysfunction

Outcome Measures

Primary Outcomes (1)

• Early Allograft dysfunction (EAD)

  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

  2 weeks from Liver transplantation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients eligible for liver transplantation

You may qualify if:

• Patients eligible for liver transplantation following National and International Guidelines

You may not qualify if:

• No agreement or inability to give informed consent
• Re-transplant patients
• Liver transplant in fulminant hepatitis

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS

Rome, 00181, Italy

RECRUITING

MeSH Terms

Conditions

Liver Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Officials

• Antonio Liguori, MD

  Catholic University of the Sacred Heart

  STUDY CHAIR

Central Study Contacts

Luca Miele, MD, PhD

CONTACT

+390630151; luca.miele@policlinicogemelli.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2023
• First Posted: March 31, 2023
• Study Start: July 6, 2020
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 31, 2023

Record last verified: 2023-02

Locations

IT (1)