Single-center Prospective Study of Non-invasive Methods for the Diagnosis of Postoperative Complications in Liver Transplant Recipients
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Rejection Acute Hepatic
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Early Allograft dysfunction (EAD)
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
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