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Functional Assessment in Liver Transplantation (FrAILT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03228290
Recruitment Status : Recruiting
First Posted : July 24, 2017
Last Update Posted : June 11, 2020
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

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.

Condition or disease
End Stage Liver Disease

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.

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Study Type : Observational
Estimated Enrollment : 5000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Functional Assessment in Liver Transplant Candidates (FrAILT) Study
Actual Study Start Date : October 12, 2011
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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 ]

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


  2. Examine the association between frailty and outcomes both before and after liver transplantation. [ Time Frame: December 31, 2023 ]
    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.

  3. Evaluate the change in frailty and physical function both before and after liver transplant or treatment utilizing the LFI. [ Time Frame: December 31, 2023 ]
    See outcome 1 for how LFI is measured.


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


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Patients who are being seen for the treatment of their liver disease.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Have severe hepatic encephalopathy at enrollment (defined by the time to complete the Numbers Connection Test (NCT) > 120 seconds).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03228290


Contacts
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Contact: Jennifer C Lai, MD, MBA (415) 476-6422 jennifer.lai@ucsf.edu
Contact: Randi Wong, BS (415) 502-7750 randi.wong@ucsf.edu

Locations
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United States, Arkansas
University of Arkansas for Medical Sciences Completed
Little Rock, Arkansas, United States, 72205
United States, California
Loma Linda University Active, not recruiting
Loma Linda, California, United States, 92354
University of California, San Francisco Recruiting
San Francisco, California, United States, 94143
Contact: Jennifer C Lai, MD, MBA    415-476-2777    jennifer.lai@ucsf.edu   
Contact: Randi Wong, BS    415-502-7750    randi.wong@ucsf.edu   
Principal Investigator: Jennifer C Lai, MD, MBA         
United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: Daniel Ganger, MD    312-695-4496    dganger@nmff.org   
Contact: Sarah Kinch    312-694-0239    sarah.kinch@northwestern.edu   
United States, Maryland
Johns Hopkins Recruiting
Baltimore, Maryland, United States, 21287
Contact: Dorry Segev, MD    410-502-6115    dorry@jhmi.edu   
Contact: Marie Nunez Duarte    443-756-5775    mnunez13@jhu.edu   
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Monica Konerman, MD       tincopa@med.umich.edu   
Contact: Haila Asefa    734-232-0284    asefah@med.umich.edu   
United States, New York
Columbia University Recruiting
New York, New York, United States, 10032
Contact: Elizabeth Verna, MD    212-305-9139    ev77@columbia.edu   
Contact: Eleonore Baughan    212-305-3839    eb3244@cumc.columbia.edu   
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Matthew Kappus, MD    804-828-8786    matthew.kappus@duke.edu   
Contact: Nicole Pavlus    919-684-0311    nicole.pavlus@duke.edu   
United States, Pennsylvania
University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15237
Contact: Michael Dunn, MD    412-647-4932    dunnma@upmc.edu   
Contact: Pam Bloomer, PA-C       bloomerpm@upmc.edu   
United States, Texas
Baylor Scott & White Health Recruiting
Dallas, Texas, United States, 75246
Contact: Robert Rahimi, MD    214-820-8500    Robert.Rahimi@BSWHealth.org   
Contact: Karen Castro    214-820-6243    Karen.Castro@BSWHealth.org   
United States, Washington
University of Washington Recruiting
Seattle, Washington, United States, 98195
Contact: Charles Landis, MD, PhD    206-744-7062    clandis@medicine.washington.edu   
Contact: Peter Nguyen    206-744-3402    phnmedic@uw.edu   
Sponsors and Collaborators
University of California, San Francisco
Investigators
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Principal Investigator: Jennifer C Lai, MD, MBA University of California, San Francisco
Additional Information:
Publications of Results:

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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03228290    
Other Study ID Numbers: 11-07513
First Posted: July 24, 2017    Key Record Dates
Last Update Posted: June 11, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of California, San Francisco:
Cirrhosis
Liver
Liver Transplant
Frailty
end stage
Additional relevant MeSH terms:
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Liver Diseases
End Stage Liver Disease
Digestive System Diseases
Liver Failure
Hepatic Insufficiency