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End Stage Liver DiseaseFrAILTNCT03228290

Functional Assessment in Liver Transplantation

An observational study of End Stage Liver Disease, run by University of California, San Francisco at 12 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
End Stage Liver Disease
How many people
5,000 participants
Where
12 sitesUnited States
Study dates
12 Oct 2011to 31 Dec 2030
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients who are being seen for the treatment of their liver disease.

Who may be able to join

  • Adult (≥18 years old)
  • Are seen for the treatment of liver disease

Who cannot join

None listed.

Trial locations and contacts

12 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Jennifer C Lai, MD, MBA contact

(415) 476-6422

jennifer.lai@ucsf.edu

Fawzy Barry, BS contact

(415) 476-6119

fawzy.barry@ucsf.edu

12 sites in 1 country

United States12 sites, 8 recruiting

  • University of Michigan

    Ann Arbor, Michigan, 48109

    Completed

  • Johns Hopkins

    Baltimore, Maryland, 21287

    Betsy King, MD, 630-244-6464, eking19@jhmi.edu

    Sherry Leung, BS, sleung7@jhu.edu

    Recruiting

  • Northwestern University

    Chicago, Illinois, 60611

    Daniel Ganger, MD, 312-695-4496, dganger@nmff.org

    Harika Reddy, BS, harika.reddy@northwestern.edu

    Recruiting

  • Baylor Scott & White Health

    Dallas, Texas, 75246

    Robert Rahimi, MD, 214-820-8500, Robert.Rahimi@BSWHealth.org

    Abby Mertz, BS, 214-818-7873, Abby.Mertz@BSWHealth.org

    Recruiting

  • Duke University Medical Center

    Durham, North Carolina, 27710

    Matthew Kappus, MD, 804-828-8786, matthew.kappus@duke.edu

    Adele Gaskin, 919-684-0742, adele.gaskin@duke.edu

    Recruiting

  • Indiana University

    Indianapolis, Indiana, 46202

    Active, not recruiting

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

    Completed

  • Loma Linda University

    Loma Linda, California, 92354

    Completed

  • Columbia University

    New York, New York, 10032

    Elizabeth Verna, MD, 212-305-9139, ev77@columbia.edu

    Geena George, 212-305-3839, gg2827@cumc.columbia.edu

    Recruiting

  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15237

    Amit Tevar, MD, tevara@upmc.edu

    Rita Johnson, RN, 412-383-8616, johnsonr1@upmc.edu

    Recruiting

  • University of California, San Francisco

    San Francisco, California, 94143

    Jennifer C Lai, MD, MBA, 415-476-2777, jennifer.lai@ucsf.edu

    Fawzy Barry, BS, 415-476-6119, fawzy.barry@ucsf.edu

    Recruiting

  • University of Washington

    Seattle, Washington, 98195

    Meredith Pearson, MD, mmp9h@medicine.washington.edu

    James Kashima, BS, (206) 685-3135, kashij@uw.edu

    Recruiting

Other trials in United States

About this study

Official title: Functional Assessment in Liver Transplant Candidates (FrAILT) Study

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.

Read the 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.
Keywords
Cirrhosis, Liver, Liver Transplant, Frailty, end stage
Medical subject headings
End Stage Liver Disease, Fibrosis, Frailty

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Frailty and functional status as assessed by grip strength, chair stands, and balance which comprise the Liver Frailty Index (LFI).

    Grip strength: Performance-based. Measured in kilograms. This was measured in each subject's dominant hand using a hand dynamometer (Jamar Hydraulic hand dynamometer). We averaged three trials.

    Chair stands: Performance-based. Measured in number of chair stands per second. Number of chair stands completed in 30 seconds.

    Balance: Performance-based. Measured in seconds. Ability to balance in three positions (feet placed side to side, semitandem, and tandem) for 10 seconds each.

    Liver Frailty Index (LFI): (coefficient x grip) + (coefficient x chair stands) + (coefficient x balance) +6

    Measured: December 31, 2023

  2. Examine the association between frailty and outcomes both before and after liver transplantation.

    Outcomes measured prior to transplant will include: waiting for transplant, died pre-transplant, deactivated too sick, deactivated for social reasons/inactive, deferred not a candidate, and transplanted. Outcomes that will be measured post transplant include: still alive, died post transplant, and re-transplanted. All measures will be acquired via patient interview or review of medical records.

    Measured: December 31, 2023

  3. Evaluate the change in frailty and physical function both before and after liver transplant or treatment utilizing the LFI.

    See outcome 1 for how LFI is measured.

    Measured: December 31, 2023

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jul 2017
  2. Study start12 Oct 2011
  3. Primary completion31 Dec 2030 (estimated)
  4. Study completion31 Dec 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
5,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03228290
Sponsor's protocol ID
11-07513
Other IDs
1R21AG067554, R21DK127275
Acronym
FrAILT
Status last verified
Jul 2026
First submitted
4 May 2017
Last updated
14 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Lai JC, Feng S, Terrault NA, Lizaola B, Hayssen H, Covinsky K. Frailty predicts waitlist mortality in liver transplant candidates. Am J Transplant. 2014 Aug;14(8):1870-9. doi: 10.1111/ajt.12762. Epub 2014 Jun 16.

    PubMed 24935609

  • Lai JC, Covinsky KE, Hayssen H, Lizaola B, Dodge JL, Roberts JP, Terrault NA, Feng S. Clinician assessments of health status predict mortality in patients with end-stage liver disease awaiting liver transplantation. Liver Int. 2015 Sep;35(9):2167-73. doi: 10.1111/liv.12792. Epub 2015 Feb 12.

    PubMed 25644788

  • Wang CW, Covinsky KE, Feng S, Hayssen H, Segev DL, Lai JC. Functional impairment in older liver transplantation candidates: From the functional assessment in liver transplantation study. Liver Transpl. 2015 Dec;21(12):1465-70. doi: 10.1002/lt.24334. Epub 2015 Nov 6.

    PubMed 26359787

  • Lai JC, Dodge JL, Sen S, Covinsky K, Feng S. Functional decline in patients with cirrhosis awaiting liver transplantation: Results from the functional assessment in liver transplantation (FrAILT) study. Hepatology. 2016 Feb;63(2):574-80. doi: 10.1002/hep.28316. Epub 2015 Dec 16.

    PubMed 26517301

  • Wang CW, Feng S, Covinsky KE, Hayssen H, Zhou LQ, Yeh BM, Lai JC. A Comparison of Muscle Function, Mass, and Quality in Liver Transplant Candidates: Results From the Functional Assessment in Liver Transplantation Study. Transplantation. 2016 Aug;100(8):1692-8. doi: 10.1097/TP.0000000000001232.

    PubMed 27314169

  • Lai JC, Volk ML, Strasburg D, Alexander N. Performance-Based Measures Associate With Frailty in Patients With End-Stage Liver Disease. Transplantation. 2016 Dec;100(12):2656-2660. doi: 10.1097/TP.0000000000001433.

    PubMed 27495749

  • Sinclair M, Poltavskiy E, Dodge JL, Lai JC. Frailty is independently associated with increased hospitalisation days in patients on the liver transplant waitlist. World J Gastroenterol. 2017 Feb 7;23(5):899-905. doi: 10.3748/wjg.v23.i5.899.

    PubMed 28223735

  • Berry KA, Kent D, Seetharaman S, Wong R, Mohamad Y, Yao F, Nunez-Duarte M, Wadhwani SI, Boyarsky BJ, Rahimi RS, Duarte-Rojo A, Kappus MR, Volk ML, Ladner DP, Segev DL, McAdams-DeMarco M, Verna EC, Ganger DR, Lai JC. Loneliness in adults awaiting liver transplantation at 7 U.S. transplant centers. Ann Hepatol. 2022 Sep-Oct;27(5):100718. doi: 10.1016/j.aohep.2022.100718. Epub 2022 Apr 20.

    PubMed 35460882

  • Berry K, Duarte-Rojo A, Grab JD, Dunn MA, Boyarsky BJ, Verna EC, Kappus MR, Volk ML, McAdams-DeMarco M, Segev DL, Ganger DR, Ladner DP, Shui A, Tincopa MA, Rahimi RS, Lai JC; from the Multi-Center Functional Assessment in Liver Transplantation (FrAILT) Study. Cognitive Impairment and Physical Frailty in Patients With Cirrhosis. Hepatol Commun. 2022 Jan;6(1):237-246. doi: 10.1002/hep4.1796. Epub 2021 Aug 24.

    PubMed 34558844

Questions about this trial

What is this clinical trial studying?

An observational study of End Stage Liver Disease, run by University of California, San Francisco at 12 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jennifer C Lai, MD, MBA ((415) 476-6422, jennifer.lai@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Frailty and functional status as assessed by grip strength, chair stands, and balance which comprise the Liver Frailty Index (LFI). (time frame: December 31, 2023). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03228290, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026.

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