Assessing functional status in liver transplant patients
Functional Assessment in Liver Transplantation
This study is trying to see how measuring strength and balance in liver transplant patients can help improve the way livers are allocated to those in need.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Baylor Research Institute Academic / other |
| Locations | 1 site (Dallas, Texas) |
| Trial ID | NCT03870568 on ClinicalTrials.gov |
What this trial studies
This observational study aims to create objective markers of frailty in patients with end-stage liver disease to improve the liver allocation process. Participants will undergo assessments of their functional status through questionnaires and physical tests, including chair stands, balance tests, and hand grip strength evaluations. These assessments will take place at baseline and during follow-up visits before and after liver transplantation, specifically at 3, 6, and 12 months post-transplant. The goal is to understand how functional status impacts patient outcomes in this population.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who are listed for liver transplantation or are eligible for listing.
Not a fit: Patients with severe hepatic encephalopathy at enrollment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved liver allocation processes and better patient outcomes for those undergoing transplantation.
How similar studies have performed: While there have been studies assessing frailty in elderly patients, this approach specifically targeting patients with cirrhosis is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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).
Where this trial is running
Dallas, Texas
- Baylor University Medical Center — Dallas, Texas, United States (Recruiting)
Study contacts
- Principal investigator: James Trotter, MD — Baylor Health Care System
- Study coordinator: Karen D Castro
- Email: karen.castro@BSWHealth.org
- Phone: 214-820-6243
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.