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NCT06382740 Clinical Trial

Selection Protocol for Liver Transplantation in Patients Aged Over 70 Years

Liver Transplantation Clinical Trial

— Over70-LT  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06382740
Other study ID # AOP2097
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 1, 2022
Est. completion date October 1, 2025

Study information
Verified date April 2024
Source Azienda Ospedaliera di Padova
Contact Umberto Cillo, Prof
Phone 049.8212211-1897
Email cillo@unipd.it
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 18
Est. completion date October 1, 2025
Est. primary completion date October 1, 2025
Accepts healthy volunteers No
Gender All
Age group 71 Years to 75 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Liver transplantation
Liver transplantation

Locations
Country Name City State
Italy U.O.C Chirurgia Epatobiliare e Trapianti Epatici, Azienda Ospedaliera di Padova Padova

Sponsors (1)
Lead Sponsor Collaborator
Azienda Ospedaliera di Padova

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary 1 year patient survival Overall patients survival at 12 months from liver transplantation 12 months
Secondary 1 year graft survival Overall graft survival at 12 months from liver transplantation 12 months
Secondary 3 months mortality and morbidity Mortality and morbidity rates at 3 months from liver transplantation 3 months
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