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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05793203
Acronym
ElastOLT
Enrollment
100
Registered
2023-03-31
Start date
2020-07-06
Completion date
2027-12-31
Last updated
2023-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

None listed

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Early Allograft dysfunction (EAD)2 weeks from Liver transplantationOlthoff 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

Countries

Italy

Contacts

Primary ContactLuca Miele, MD, PhD
luca.miele@policlinicogemelli.it+390630151

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026