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
|Condition or disease|
|End Stage Liver Disease|
Patients will be asked to perform the following study procedures:
- Assessment of cognitive function, quality of life, and/or personality using cognitive tests and questionnaires.
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
- 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.
- Blood draw, urine and stool samples will be collected for a sub-group of 1000 patients.
- Adipose, muscle, liver tissue, and blood will be collected during the liver transplant surgery for a sub-group of 1000 patients.
|Study Type :||Observational|
|Estimated Enrollment :||5000 participants|
|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|
- 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
- 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.
- 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
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
|Contact: Jennifer C Lai, MD, MBA||(415) firstname.lastname@example.org|
|Contact: Randi Wong, BS||(415) email@example.com|
|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 firstname.lastname@example.org|
|Contact: Randi Wong, BS 415-502-7750 email@example.com|
|Principal Investigator: Jennifer C Lai, MD, MBA|
|United States, Illinois|
|Chicago, Illinois, United States, 60611|
|Contact: Daniel Ganger, MD 312-695-4496 firstname.lastname@example.org|
|Contact: Sarah Kinch 312-694-0239 email@example.com|
|United States, Maryland|
|Baltimore, Maryland, United States, 21287|
|Contact: Dorry Segev, MD 410-502-6115 firstname.lastname@example.org|
|Contact: Marie Nunez Duarte 443-756-5775 email@example.com|
|United States, Michigan|
|University of Michigan||Recruiting|
|Ann Arbor, Michigan, United States, 48109|
|Contact: Monica Konerman, MD firstname.lastname@example.org|
|Contact: Haila Asefa 734-232-0284 email@example.com|
|United States, New York|
|New York, New York, United States, 10032|
|Contact: Elizabeth Verna, MD 212-305-9139 firstname.lastname@example.org|
|Contact: Eleonore Baughan 212-305-3839 email@example.com|
|United States, North Carolina|
|Duke University Medical Center||Recruiting|
|Durham, North Carolina, United States, 27710|
|Contact: Matthew Kappus, MD 804-828-8786 firstname.lastname@example.org|
|Contact: Nicole Pavlus 919-684-0311 email@example.com|
|United States, Pennsylvania|
|University of Pittsburgh||Recruiting|
|Pittsburgh, Pennsylvania, United States, 15237|
|Contact: Michael Dunn, MD 412-647-4932 firstname.lastname@example.org|
|Contact: Pam Bloomer, PA-C email@example.com|
|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 firstname.lastname@example.org|
|Contact: Peter Nguyen 206-744-3402 email@example.com|
|Principal Investigator:||Jennifer C Lai, MD, MBA||University of California, San Francisco|