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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04754503
Recruitment Status : Recruiting
First Posted : February 15, 2021
Last Update Posted : January 12, 2023
Sponsor:
Information provided by (Responsible Party):
Gérond'if

Study Description
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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

Condition or disease
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 Design
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Study Type : Observational
Estimated Enrollment : 125 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Survival and Quality of Life After Liver Transplantation in Patients Aged 65 and Over
Actual Study Start Date : April 9, 2021
Estimated Primary Completion Date : April 2024
Estimated Study Completion Date : April 2025

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Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Assessment of survival and quality of life after liver transplantation according to the quality of life score [ Time Frame: 12 Months ]

Secondary Outcome Measures :
  1. Detecting depression in the elderly according the Geriatric Depression Scale (GDS) [ Time Frame: 12 Months ]

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

Eligibility Criteria
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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04754503


Contacts
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Contact: Isabelle Dufour +33 (0)185781010 isabelle.dufour@gerondif.org
Contact: Prisca Lucas, PhD +33 (0)185781010 prisca.lucas@gerondif.org

Locations
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France
Geriatric Department, Paul Brousse Hospital Recruiting
Villejuif, Île-de-France, France, 94804
Contact: Emmanuelle DURON, MD PhD    +33(0)145593843    emmanuelle.duron@aphp.fr   
Sponsors and Collaborators
Gérond'if
Investigators
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Study Chair: Duron Emmanuelle, MD PhD Geriatric Department, Paul Brousse Hospital
More Information
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Responsible Party: Gérond'if
ClinicalTrials.gov Identifier: NCT04754503    
Other Study ID Numbers: 2020-A03063-36
First Posted: February 15, 2021    Key Record Dates
Last Update Posted: January 12, 2023
Last Verified: January 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gérond'if:
liver transplant