NCT05793203 Single-center Prospective Study of Non-invasive Methods for the Diagnosis of Postoperative Complications in Liver Transplant Recipients
| NCT ID | NCT05793203 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
| Condition | Rejection Acute Hepatic |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2020-07-06 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2020-07-06 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Antonio Liguori, MD
STUDY CHAIR
Catholic University of the Sacred Heart
Frequently Asked Questions
Who can join the NCT05793203 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Rejection Acute Hepatic. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05793203 currently recruiting?
Yes, NCT05793203 is actively recruiting participants. Contact the research team at luca.miele@policlinicogemelli.it for enrollment information.
Where is the NCT05793203 trial being conducted?
This trial is being conducted at Rome, Italy.
Who is sponsoring the NCT05793203 clinical trial?
NCT05793203 is sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. The principal investigator is Antonio Liguori, MD at Catholic University of the Sacred Heart. The trial plans to enroll 100 participants.