Functional Assessment in Liver Transplantation

End Stage Liver Disease Clinical Trial

— FrAILT  

Official title:

Functional Assessment in Liver Transplant Candidates (FrAILT) Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03228290
• Other study ID #: 11-07513
• Secondary ID: 1R21AG067554R21D
• Status: Recruiting
• Start date: October 12, 2011
• Est. completion date: December 31, 2028

Study information

• Verified date: June 2024
• Source: University of California, San Francisco
• Contact: Jennifer C Lai, MD, MBA
• Phone: (415) 476-6422
• Email: jennifer.lai[@]ucsf.edu
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: December 31, 2028
• Est. primary completion date: December 31, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult (=18 years old)

• Are seen for the treatment of liver disease

Related Conditions & MeSH terms

• End Stage Liver Disease
• Liver Diseases

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	Johns Hopkins	Baltimore	Maryland
United States	Northwestern University	Chicago	Illinois
United States	Baylor Scott & White Health	Dallas	Texas
United States	Duke University Medical Center	Durham	North Carolina
United States	Indiana University	Indianapolis	Indiana
United States	University of Arkansas for Medical Sciences	Little Rock	Arkansas
United States	Loma Linda University	Loma Linda	California
United States	Columbia University	New York	New York
United States	University of Pittsburgh	Pittsburgh	Pennsylvania
United States	University of California, San Francisco	San Francisco	California
United States	University of Washington	Seattle	Washington

Sponsors (3)

Lead Sponsor	Collaborator
University of California, San Francisco	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

References & Publications (7)

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: — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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 — View Citation

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):16 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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

External 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.