Severely Deconditioned Liver Transplant Candidates Structured Prehabilitation Pathway
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Scottsdale/Phoenix, Arizona: 22-010568
About this study
The purpose of this study is to improve pre- and post- transplant outcomes of severely frail and/or severely malnourished patients. Implement a higher-intensity strategy for highest-risk patients who are being evaluated for transplant, and compare with current practice.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion criteria:
- Liver transplant candidates who are deferred for listing for at least 3 months (e.g., alcoholic cirrhosis patients needing to complete rehabilitation programs)
- Severe liver decompensation (Child Score C) plus any TWO of the following:
- BMI < 20;
- Involuntary loss of > 10% body weight over 6 months;
- 6-minute walk distance < 300 meters;
- Liver frailty index > 81th percentile (> 4.5);
- Paracentesis or thoracentesis dependence.
Exclusion Criteria:
- Outside the Greater Phoenix area.
Note: Other protocol defined Inclusion/Exclusion Criteria may apply.
Eligibility last updated 12/27/22. Questions regarding updates should be directed to the study team contact.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Scottsdale/Phoenix, Ariz.
Mayo Clinic principal investigator Channa Jayasekera, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available