Selection Protocol for Liver Transplantation in Patients Aged Over 70 Years

NCT06382740 | Recruiting

• 1 other identifier: AOP2097
• Study Type: observational
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

End Stage Liver DIsease; Liver Transplantation; Old Age

Keywords

liver transplantation; old recipients; age>70 years

Outcome Measures

Primary Outcomes (1)

• 1 year patient survival

  Overall patients survival at 12 months from liver transplantation

  12 months

Secondary Outcomes (2)

• 1 year graft survival

  12 months

• 3 months mortality and morbidity

  3 months

Interventions

Liver transplantation PROCEDURE

Liver transplantation

Eligibility Criteria

• Age: 71 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Azienda Ospedaliera di Padova: lead

Study Sites (1)

U.O.C Chirurgia Epatobiliare e Trapianti Epatici, Azienda Ospedaliera di Padova

Padua, 35128, Italy

RECRUITING

MeSH Terms

Conditions

End Stage Liver Disease

Interventions

Liver Transplantation

Condition Hierarchy (Ancestors)

Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Tissue Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Digestive System Surgical Procedures; Surgical Procedures, Operative; Organ Transplantation; Transplantation

Study Officials

• Umberto Cillo, Prof

  Azienda Ospedaliera di Padova

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Umberto Cillo, Prof

CONTACT

049.8212211-1897; cillo@unipd.it

Alessandro Vitale, Prof

CONTACT

alessandro.vitale@unipd.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: March 9, 2023
• First Posted: April 24, 2024
• Study Start: October 1, 2022
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: April 24, 2024

Record last verified: 2024-04

Locations

IT (1)