Summary

for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion
Jennifer C Lai

Description

Summary

This will be a prospective cohort study of patients with cirrhosis who are listed for liver transplantation. 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 again undergo functional assessments at every clinic visit through 12 months after transplant.

Official Title

Functional Assessment in Liver Transplant Candidates (FrAILT) Study

Details

Patients will be asked to perform the following study procedures:

  1. Assessment for hepatic encephalopathy using the Numbers Connection Test. This test requires the patient to connect numbers in sequence that are scattered at random on a piece of paper.
  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

  1. 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.
  2. Blood draw, urine and stool samples will be collected for a sub-group of 1000 patients.
  3. Adipose, muscle, liver tissue, and blood will be collected during the liver transplant surgery for a sub-group of 1000 patients.

Keywords

End Stage Liver DiseaseCirrhosisLiverLiver TransplantFrailtyend stageLiver Diseases

Eligibility

You can join if…

Open to people ages 18 years and up

  • Adult (≥18 years old)
  • Underlying cirrhosis
  • Listed for liver transplantation
  • Are seen in the outpatient clinic setting

You CAN'T join if...

  • Have severe hepatic encephalopathy at enrollment (defined by the time to complete the Numbers Connection Test (NCT) > 120 seconds).

Locations

  • University of California, San Franciscoaccepting new patients
    San FranciscoCalifornia94143United States
  • Loma Linda Universityaccepting new patients
    Loma LindaCalifornia92354United States

Lead Scientist

  • Jennifer C Lai
    Dr. Lai is a general and transplant hepatologist who specializes in caring for patients with chronic viral hepatitis, autoimmune disorders, and cirrhosis, particularly those awaiting liver transplantation. Her academic mission is to improve the lives of patients with end-stage liver disease through the application of core principles of geriatrics into the care of patients with cirrhosis.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
Links
We developed a novel clinical liver frailty index, consisting of hand grip strength, timed chair stands, and balance testing, that correctly reclassifies 1 in 5 patients to their accurate survival status, compared to MELDNa alone.
ID
NCT03228290
Study Type
Observational
Last Updated