Functional Assessment in Liver Transplantation

NCT03228290 | Recruiting

• 3 other identifiers: 11-075131R21AG067554R21DK127275
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 12

Brief 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.

Conditions

End Stage Liver Disease

Keywords

Cirrhosis; Liver; Liver Transplant; Frailty; end stage

Outcome Measures

Primary Outcomes (3)

• 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

  December 31, 2023

• 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.

  December 31, 2023

• 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.

  December 31, 2023

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Institute on Aging (NIA): collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (12)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

COMPLETED

Loma Linda University

Loma Linda, California, 92354, United States

COMPLETED

University of California, San Francisco

San Francisco, California, 94143, United States

RECRUITING

Northwestern University

Chicago, Illinois, 60611, United States

RECRUITING

Indiana University

Indianapolis, Indiana, 46202, United States

ACTIVE NOT RECRUITING

Johns Hopkins

Baltimore, Maryland, 21287, United States

RECRUITING

University of Michigan

Ann Arbor, Michigan, 48109, United States

COMPLETED

Columbia University

New York, New York, 10032, United States

RECRUITING

Duke University Medical Center

Durham, North Carolina, 27710, United States

RECRUITING

University of Pittsburgh

Pittsburgh, Pennsylvania, 15237, United States

RECRUITING

Baylor Scott & White Health

Dallas, Texas, 75246, United States

RECRUITING

University of Washington

Seattle, Washington, 98195, United States

RECRUITING

Related Publications (9)

• 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.

  PMID: 24935609 RESULT

• 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.

  PMID: 25644788 RESULT

• 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.

  PMID: 26359787 RESULT

• 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.

  PMID: 26517301 RESULT

• 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.

  PMID: 27314169 RESULT

• 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.

  PMID: 27495749 RESULT

• 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.

  PMID: 28223735 RESULT

• 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.

  PMID: 35460882 DERIVED

• 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.

  PMID: 34558844 DERIVED

Related 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.

Biospecimen

Retention: SAMPLES WITH DNA

Sub-group of 1000 patients will have one single blood draw of 2 tablespoons of blood and provide a urine and stool sample (about 5ml each or 1 teaspoon each), at the time of consent. If they agree to participate in the DNA genetic testing, then they will have an additional 1 tablespoon drawn during the same venipuncture. Sub-group of 1000 patients will have adipose, muscle, liver tissue, and blood collected during the liver transplant surgery. * 8 cm³ of muscle tissue from the rectus muscle in the abdomen. * 8 cm³ of adipose tissue from the subcutaneous and visceral adipose tissue of the abdomen. * 8 cm³ of liver tissue from the explanted liver * 4 tablespoons of blood

MeSH Terms

Conditions

End Stage Liver Disease; Fibrosis; Frailty

Condition Hierarchy (Ancestors)

Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jennifer C Lai, MD, MBA

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer C Lai, MD, MBA

CONTACT

(415) 476-6422; jennifer.lai@ucsf.edu

Fawzy Barry, BS

CONTACT

(415) 476-6119; fawzy.barry@ucsf.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2017
• First Posted: July 24, 2017
• Study Start: October 12, 2011
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: July 4, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (12)