TerminatedNot Applicable

Functional Assessment in Liver Transplantation

Stopped: study transitioned from LIRB to CIRB

United States411 participantsStarted 2015-10-06

Plain-language summary

In order to ensure the equity of the liver allocation process, it is important to create objective, scientifically validated markers of frailty in patients with end-stage liver disease that accurately predict patient outcomes. Many measures have been developed to assess this clinical state in elderly patients, but none have been applied to patients with cirrhosis, a population at increased risk for accelerated functional decline. This protocol is designed to learn more about the effects of functional status (also known as "frailty") in liver transplant patients and patient outcomes both before and after liver transplant.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Adults (≥18 years old) * Listed for liver transplantation, or are "listable" - i.e, have undergone formal evaluation and been approved for listing if/when patients achieve high enough priority * Are seen in the outpatient clinic setting Exclusion Criteria: * Have severe hepatic encephalopathy at enrollment (defined by the time to complete the Numbers Connection Test (NCT) \> 120 seconds, which is the first test that the participants complete upon enrollment).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Fried Frailty Index measurements in 300 patients with end-stage liver disease awaiting liver transplantation

Timeframe: 5 years

Liver Frailty Index measurements in 300 patients with end-stage liver disease awaiting liver transplantation

Timeframe: 5 years

Numbers Connection test measurements in 300 patients with end-stage liver disease

Timeframe: 5 years

Work status

Timeframe: 5 years

Hospitalizations

Timeframe: 5 years

Activities of daily living (ADLs)

Timeframe: At 1 year post transplantation

Instrumental Activities of Daily Living (IADLs)

Timeframe: At 1 year post transplantation

Trial details

NCT IDNCT03870568

SponsorBaylor Research Institute

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-05-08

View on ClinicalTrials.gov More Cirrhosis trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Fried Frailty Index measurements in 300 patients with end-stage liver disease awaiting liver transplantation

Timeframe: 5 years

Liver Frailty Index measurements in 300 patients with end-stage liver disease awaiting liver transplantation

Timeframe: 5 years

Numbers Connection test measurements in 300 patients with end-stage liver disease

Timeframe: 5 years

Work status

Timeframe: 5 years

Hospitalizations

Timeframe: 5 years

Activities of daily living (ADLs)

Timeframe: At 1 year post transplantation

Instrumental Activities of Daily Living (IADLs)

Timeframe: At 1 year post transplantation