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
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• End Stage Liver DIsease
• Liver Diseases
• Liver Transplantation
• Old Age

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