NCT03228290

Functional Assessment in Liver Transplantation

Functional Assessment in Liver Transplant Candidates (FrAILT) Study

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 5,000 (estimated)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This will be a prospective cohort study of patients with liver disease. Subjects will undergo geriatric assessments of frailty, functional status, and disability using functional status measures at baseline and at every clinic visit in the pre-transplant setting. Subjects will also answer questions regarding quality of life, personality, and/or cognitive function. Subjects will again undergo assessments at every clinic visit through 12 months after transplant. Then, they will be followed annually.

Detailed description

Patients will be asked to perform the following study procedures: 1. Assessment of cognitive function, quality of life, and/or personality using cognitive tests and questionnaires. 2. Measures of frailty and disability selected to capture the multi-dimensional aspects of frailty including functional status and physiologic reserve: Fried Frailty Score: weakness (test of grip strength), exhaustion (patient interview), slowness (gait speed), low activity (patient interview) Short Physical Performance Battery: repeated chair stands, balance testing with feet together, 13-foot walk 3. Laboratory tests will all be obtained from the medical record: creatinine, total bilirubin, INR, sodium, albumin. All of these tests are necessary for listing for liver transplantation. 4. Blood draw, urine and stool samples will be collected for a sub-group of 1000 patients. 5. Adipose, muscle, liver tissue, and blood will be collected during the liver transplant surgery for a sub-group of 1000 patients.

Conditions

• End Stage Liver Disease

Timeline

• Start date: 2011-10-12
• Primary completion: 2028-12-31
• Completion: 2028-12-31
• First posted: 2017-07-24
• Last updated: 2025-07-04

Locations

12 sites across 1 country: United States