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NCT05793203 Clinical Trial

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

Liver Dysfunction Clinical Trial

— ElastOLT  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05793203
Other study ID # 4176
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 6, 2020
Est. completion date December 31, 2027

Study information
Verified date February 2023
Source Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Contact Luca Miele, MD, PhD
Phone +390630151
Email luca.miele@policlinicogemelli.it
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date December 31, 2027
Est. primary completion date December 31, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Italy Fondazione Policlinico Universitario A. Gemelli IRCCS Rome

Sponsors (1)
Lead Sponsor Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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