Functional Assessment in Liver Transplantation

Therapuetic Areas:Gastroenterology
Age Range:18 - Any
Start Date:October 12, 2011
End Date:December 31, 2023
Contact:Jennifer C Lai, MD, MBA
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

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
Baltimore, Maryland 21218
(410) 516-8000
Phone: 410-614-3822
Johns Hopkins The Johns Hopkins University opened in 1876, with the inauguration of its first...
Baltimore, MD
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529 West Markham Street
Little Rock, Arkansas 72205
(501) 686-7000
Phone: 501-686-5177
University of Arkansas for Medical Sciences The University of Arkansas for Medical Sciences (UAMS) in...
Little Rock, AR
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116th St and Broadway
New York, New York 10027
(212) 854-1754
Phone: 212-305-9139
Columbia University In 1897, the university moved from Forty-ninth Street and Madison Avenue, where it...
New York, NY
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4200 Fifth Ave
Pittsburgh, Pennsylvania 15260
(412) 624-4141
Phone: 412-647-4932
University of Pittsburgh The University of Pittsburgh is a state-related research university, founded as the...
Pittsburgh, PA
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303 East Superior Street
Chicago, Illinois 60611
Phone: 312-695-4496
Chicago, IL
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3500 Gaston Avenue
Dallas, Texas 75246
Phone: 214-820-8500
Dallas, TX
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2301 Erwin Rd
Durham, North Carolina 27710
Phone: 804-828-8786
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
Durham, NC
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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...
Loma Linda, CA
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San Francisco, California 94143
Principal Investigator: Jennifer C Lai, MD, MBA
Phone: 415-476-2777
San Francisco, CA
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