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

• ClinicalTrials.gov Identifier: NCT04754503
• Recruitment Status: Recruiting
• First Posted: February 15, 2021
• Last Update Posted: January 12, 2023
• Sponsor: Gérond'if
• Information provided by (Responsible Party): Gérond'if

Tracking Information

• First Submitted Date: February 12, 2021
• First Posted Date: February 15, 2021
• Last Update Posted Date: January 12, 2023
• Actual Study Start Date: April 9, 2021
• Estimated Primary Completion Date: April 2024 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: February 12, 2021): Assessment of survival and quality of life after liver transplantation according to the quality of life score [ Time Frame: 12 Months ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (submitted: February 12, 2021): Detecting depression in the elderly according the Geriatric Depression Scale (GDS) [ Time Frame: 12 Months ]
• Original Secondary Outcome Measures: Same as current

Current Other Pre-specified Outcome Measures (submitted: February 12, 2021)

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

• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

• Brief Title: Survival and Quality of Life After Liver Transplantation in Patients Aged 65 and Over
• Official Title: Survival and Quality of Life After Liver Transplantation in Patients Aged 65 and Over
• Brief Summary: 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

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
• Study Design: Observational Model: Case-Only; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• 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.
• Condition: Patients Suitable for a Liver Transplant
• Intervention: Not Provided
• Study Groups/Cohorts: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: February 12, 2021): 125
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: April 2025
• Estimated Primary Completion Date: April 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 65 Years and older (Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Isabelle Dufour; +33 (0)185781010; isabelle.dufour@gerondif.org

Contact: Prisca Lucas, PhD; +33 (0)185781010; prisca.lucas@gerondif.org

• Listed Location Countries: France

Administrative Information

• NCT Number: NCT04754503
• Other Study ID Numbers: 2020-A03063-36
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Gérond'if
• Original Responsible Party: Same as current
• Current Study Sponsor: Gérond'if
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Chair: Duron Emmanuelle, MD PhD; Geriatric Department, Paul Brousse Hospital

• PRS Account: Gérond'if
• Verification Date: January 2023