Selection Protocol for Liver Transplantation in Patients Aged Over 70 Years (Over70-LT)

April 22, 2024 updated by: Prof. Umberto Cillo, Azienda Ospedaliera di Padova

Prospective Evaluation of a Selection Protocol for Patients Over 70 Years Old for Liver Transplantation

Increased life expectancy and aging population has led to a trend of increasing liver transplant (LT) volume in the elderly. Nowadays, advanced age is not considered an absolute contraindication for LT but elderly LT candidates typically have an age-associated burden of comorbid conditions that can pose several clinical challenges during the selection/evaluation process for LT. Specific algorithms for elderly patient selection for LT are not well established; however, consensus agreement is that elderly LT candidates need a more rigorous selection process.

This study proposes a "step by step" algorithm of selection for liver transplant candidates more than 70 years.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

18

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Umberto Cillo, Prof
  • Phone Number: 049.8212211-1897
  • Email: cillo@unipd.it

Study Contact Backup

Study Locations

  • Italy
      • Padova, Italy, 35128
        • Recruiting
        • U.O.C Chirurgia Epatobiliare e Trapianti Epatici, Azienda Ospedaliera di Padova
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Consecutive candidates for liver transplant with age >70 and ≤ 75 years

Description

Inclusion Criteria:

  • Age >70 years and ≤ 75 years
  • Liver transplant from cadaveric donor
  • First liver transplant
  • End stage liver disease or liver tumor

Exclusion Criteria:

  • Age ≤ 70 years
  • Living donor liver transplant
  • Previous liver transplant
  • Liver transplant for acute liver failure

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
1 year patient survival
Time Frame: 12 months
Overall patients survival at 12 months from liver transplantation
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
1 year graft survival
Time Frame: 12 months
Overall graft survival at 12 months from liver transplantation
12 months
3 months mortality and morbidity
Time Frame: 3 months
Mortality and morbidity rates at 3 months from liver transplantation
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Ospedaliera di Padova

Investigators

  • Principal Investigator: Umberto Cillo, Prof, Azienda Ospedaliera di Padova

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2022

Primary Completion (Estimated)

October 1, 2025

Study Completion (Estimated)

October 1, 2025

Study Registration Dates

First Submitted

March 9, 2023

First Submitted That Met QC Criteria

April 22, 2024

First Posted (Actual)

April 24, 2024

Study Record Updates

Last Update Posted (Actual)

April 24, 2024

Last Update Submitted That Met QC Criteria

April 22, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AOP2097

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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