Functional Assessment in Liver Transplantation



Status:Recruiting
Conditions:Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - Any
Updated:3/16/2019
Start Date:October 12, 2011
End Date:December 31, 2023
Contact:Jennifer C Lai, MD, MBA
Email:jennifer.lai@ucsf.edu
Phone:(415) 476-6422

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Functional Assessment in Liver Transplant Candidates (FrAILT) Study

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.

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

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.

Inclusion Criteria:

- Adult (≥18 years old)

- Underlying cirrhosis

- Listed for liver transplantation

- Are seen in the outpatient clinic setting

Exclusion Criteria:

- Have severe hepatic encephalopathy at enrollment (defined by the time to complete the
Numbers Connection Test (NCT) > 120 seconds).
We found this trial at
9
sites
San Francisco, California 94143
Principal Investigator: Jennifer C Lai, MD, MBA
Phone: 415-476-2777
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529 West Markham Street
Little Rock, Arkansas 72205
(501) 686-7000
Phone: 501-686-5177
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New York, New York 10027
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(412) 624-4141
Phone: 412-647-4932
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303 East Superior Street
Chicago, Illinois 60611
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3500 Gaston Avenue
Dallas, Texas 75246
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Durham, North Carolina 27710
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Loma Linda University
Loma Linda, California 92354
(909) 558-4000
Phone: 909-558-3636
Loma Linda University Loma Linda University (LLU) is a Seventh-day Adventist educational health-sciences institution with...
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