Actively Recruiting
Single-center Prospective Study of Non-invasive Methods for the Diagnosis of Postoperative Complications in Liver Transplant Recipients
Led by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Updated on 2023-03-31
100
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Liver transplantation can lead to various early and late complications, including surgical issues, infections, and immune-related problems like acute cellular rejection (ACR). These complications often show changes in liver enzymes and liver function tests, which may result in early allograft dysfunction (EAD). Currently, there is no reliable biomarker to predict the development of ACR or EAD after transplantation. This study aims to explore the role of non-invasive instrumental and biological markers during the early post-transplant period to better understand and predict these complications. This observational study involves monitoring liver transplant recipients using non-invasive methods to assess their liver function and detect possible complications. The study focuses on evaluating the prognostic value of these markers within the first two weeks after transplantation. There are no specific drug treatments or interventions assigned, as the study observes patients following standard transplant procedures and care. Participants will be followed closely in the early post-transplant phase, with assessments including liver enzyme levels and liver function tests. The main outcome measured is the occurrence of early allograft dysfunction within two weeks after liver transplantation. Researchers will collect and analyze non-invasive instrumental and biological marker data to understand their predictive value. The total duration of participation depends on the early post-transplant monitoring period, with safety and liver function continuously evaluated.
CONDITIONS
Brief Title
Single-center Prospective Study of Non-invasive Methods for the Diagnosis of Postoperative Complications in Liver Transplant Recipients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients eligible for liver transplantation following National and International Guidelines
- Age between 18 and 75 years
- Ability to provide informed consent
You will not qualify if you...
- No agreement or inability to give informed consent
- Re-transplant patients
- Liver transplant in fulminant hepatitis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 2 weeks from liver transplantation
Participants undergo non-invasive assessments to diagnose postoperative complications after liver transplantation.
Duration - Up to study completion date
Participants are observed over time to monitor health outcomes following liver transplantation.
Trial Site Locations
Total: 1 location
1
Fondazione Policlinico Universitario A. Gemelli IRCCS
Rome, Italy, 00181
Actively Recruiting
Research Team
L
Luca Miele, MD, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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