Frailty predicts waitlist mortality in liver transplant candidates.
J C Lai, S Feng, N A Terrault...
https://pubmed.ncbi.nlm.nih.gov/24935609Actively Recruiting
Age: 18Years +
All Genders
ID03228290
Functional Assessment in Liver Transplant Candidates (FrAILT) Study
Led by University of California, San Francisco · Updated on 2025-07-04
5000
Participants Needed
12
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of California, San Francisco
Lead Sponsor
N
National Institute on Aging (NIA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are conducting a prospective cohort study involving adults with liver disease who are candidates for liver transplantation. The study aims to assess frailty, functional status, and disability using various functional measures. It also evaluates quality of life, personality, and cognitive function through questionnaires and cognitive tests. The purpose is to understand how frailty and physical function relate to outcomes before and after liver transplantation. Participants will undergo assessments including cognitive tests, quality of life evaluations, and physical performance measures such as grip strength, chair stands, balance, gait speed, and interviews regarding exhaustion and activity levels. Laboratory tests like creatinine, bilirubin, INR, sodium, and albumin will be collected from medical records. A subgroup of 1000 patients will provide blood, urine, stool, and tissue samples during transplant surgery for further study. Assessments will be done at baseline and at every clinic visit before transplant, continuing through 12 months post-transplant, then annually afterward. Researchers will track changes in frailty and physical function over time using the Liver Frailty Index. The study will monitor these measures to examine their association with transplant outcomes and overall patient health during follow-up periods lasting several years.
CONDITIONS
Brief Title
Functional Assessment in Liver Transplantation
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Adult (≥18 years old)
- Are seen for the treatment of liver disease
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - Ongoing throughout study participation
Participants undergo assessments of cognitive function, quality of life, personality, and measures of frailty and disability including grip strength, chair stands, balance testing, and gait speed.
Visits occur as participants are seen for liver disease treatment
Sample Collection
Duration - During the course of treatment and surgery as applicable
Blood draw, urine, and stool samples are collected for a sub-group of participants. Additional tissue samples are collected during liver transplant surgery for this sub-group.
Sample collection occurs during clinical visits and surgery
Long-term Monitoring
Duration - Up to study completion on December 31, 2028
Participants are observed for changes in frailty, physical function, and liver transplant outcomes before and after liver transplantation.
Follow-up assessments occur during routine care visits
Trial Site Locations
Total: 12 locations
1
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
Completed
2
Loma Linda University
Loma Linda, California, United States, 92354
Completed
3
University of California, San Francisco
San Francisco, California, United States, 94143
Actively Recruiting
4
Northwestern University
Chicago, Illinois, United States, 60611
Actively Recruiting
5
Indiana University
Indianapolis, Indiana, United States, 46202
Active, Not Recruiting
6
Johns Hopkins
Baltimore, Maryland, United States, 21287
Actively Recruiting
7
University of Michigan
Ann Arbor, Michigan, United States, 48109
Completed
8
Columbia University
New York, New York, United States, 10032
Actively Recruiting
9
Duke University Medical Center
Durham, North Carolina, United States, 27710
Actively Recruiting
10
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15237
Actively Recruiting
11
Baylor Scott & White Health
Dallas, Texas, United States, 75246
Actively Recruiting
12
University of Washington
Seattle, Washington, United States, 98195
Actively Recruiting
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Research Team
J
Jennifer C Lai, MD, MBA
F
Fawzy Barry, BS
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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Published Research Related To This Trial
Clinician assessments of health status predict mortality in patients with end-stage liver disease awaiting liver transplantation.
Jennifer C Lai, Kenneth E Covinsky, Hilary Hayssen...
https://pubmed.ncbi.nlm.nih.gov/25644788Functional impairment in older liver transplantation candidates: From the functional assessment in liver transplantation study.
Connie W Wang, Kenneth E Covinsky, Sandy Feng...
https://pubmed.ncbi.nlm.nih.gov/26359787Functional decline in patients with cirrhosis awaiting liver transplantation: Results from the functional assessment in liver transplantation (FrAILT) study.
Jennifer C Lai, Jennifer L Dodge, Saunak Sen...
https://pubmed.ncbi.nlm.nih.gov/26517301A Comparison of Muscle Function, Mass, and Quality in Liver Transplant Candidates: Results From the Functional Assessment in Liver Transplantation Study.
Connie W Wang, Sandy Feng, Kenneth E Covinsky...
https://pubmed.ncbi.nlm.nih.gov/27314169Performance-Based Measures Associate With Frailty in Patients With End-Stage Liver Disease.
Jennifer C Lai, Michael L Volk, Debra Strasburg...
https://pubmed.ncbi.nlm.nih.gov/27495749Frailty is independently associated with increased hospitalisation days in patients on the liver transplant waitlist.
Marie Sinclair, Eduard Poltavskiy, Jennifer L Dodge...
https://pubmed.ncbi.nlm.nih.gov/28223735Loneliness in adults awaiting liver transplantation at 7 U.S. transplant centers.
Kacey A Berry, Dorothea Kent, Srilakshmi Seetharaman...
https://pubmed.ncbi.nlm.nih.gov/35460882Cognitive Impairment and Physical Frailty in Patients With Cirrhosis.
Kacey Berry, Andres Duarte-Rojo, Joshua D Grab...
https://pubmed.ncbi.nlm.nih.gov/34558844