Survival and Quality of Life After Liver Transplantation in Patients Aged 65 and Over (LT 65+)

The main objective of this non-interventional, single-center study is to assess survival and associated factors at 1 year in patients aged 65 and over who received liver transplantation

Study Overview

• Status: Recruiting
• Conditions: Patients Suitable for a Liver Transplant

Detailed Description

The expected benefits of this study are to identify the preoperative risk factors of mortality from liver transplant failure in patients aged 65 and over (90-day mortality and 1 and 3-year survival) will allow better selection. candidates for this age group. In the current context of organ shortage, this study should make it possible to reduce the number of risky transplants and thus improve the allocation of grafts.Inclusion of patients who meet the inclusion criteria will be carried out during their hospitalization in the surgical department of the hepato-bilary center.

Included patients will receive a standardized geriatric assessment in addition to the usual assessment for a liver transplant.

The geriatric assessment will be carried out and conducted as follows: geriatric scores and quality of life questionnaires. Two geriatricians will perform the physical examination and blindly estimate each other's probability of survival at 90 days using a Likert scale.

Geriatricians will be blinded to hepatic data (reasons for transplantation). The consultation as well as the completion of the questionnaire will be carried out during the pre-transplantation assessment.

Survival and quality of life will be assessed at 3 and 12 months post-transplantaion.

• Study Type: Observational
• Enrollment (Anticipated): 125

Contacts and Locations

• Study Contact: Name: Isabelle Dufour; Phone Number: +33 (0)185781010; Email: isabelle.dufour@gerondif.org
• Study Contact Backup: Name: Prisca Lucas, PhD; Phone Number: +33 (0)185781010; Email: prisca.lucas@gerondif.org

Study Locations

• France
  • Île-de-France
    • Villejuif, Île-de-France, France, 94804
      • Recruiting
      • Geriatric Department, Paul Brousse Hospital
      • Contact: Emmanuelle DURON, MD PhD; Phone Number: +33(0)145593843; Email: emmanuelle.duron@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients over 65 years of age who are candidates for a liver transplant at the participating center during the study period.

Description

Inclusion Criteria:

• Candidates for liver transplantation
• Having expressed non-oppostion to his participation in study and documented in his medical file
• With social coverage

Exclusion Criteria:

• Emergency transplant patients
• Patient already included in another study
• Patient under guardianship or curatorship
• Expressing his opposition to participate in the study

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Assessment of survival and quality of life after liver transplantation according to the quality of life score	12 Months

Secondary Outcome Measures

Outcome Measure	Time Frame
Detecting depression in the elderly according the Geriatric Depression Scale (GDS)	12 Months

Other Outcome Measures

Outcome Measure	Time Frame
Assessment of commorbidity risk according Charlson score	At inclusion
Assessment of the degree of patient dependence according "Index of Independence in Activities of Daily Living" KATZ scale	12 Months
Assessment of patient's level of dependence through an appreciation of instrumental activities of daily living according Lawton scale	12 months
Assessment of quality of life according the SF-36 Health Status Questionnaire	12 months
Assessment of the emotional, physical and financial burden on a caregiver according Zarit burden scale	12 months

Collaborators and Investigators

• Sponsor: Gérond'if
• Investigators: Study Chair: Duron Emmanuelle, MD PhD, Geriatric Department, Paul Brousse Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 9, 2021
• Primary Completion (Anticipated): April 1, 2024
• Study Completion (Anticipated): April 1, 2025

Study Registration Dates

• First Submitted: February 12, 2021
• First Submitted That Met QC Criteria: February 12, 2021
• First Posted (Actual): February 15, 2021

Study Record Updates

• Last Update Posted (Actual): January 12, 2023
• Last Update Submitted That Met QC Criteria: January 11, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: liver transplant
• Other Study ID Numbers: 2020-A03063-36

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No