Adverse Outcomes and Mortality in Liver Transplant
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMayo Clinic
About this trial
Prospective natural history pilot study to explore the link between muscle composition using an MRI-based Muscle Assessment Score (MAsS) and adverse outcomes in liver transplant candidates.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
All patients with end-stage liver disease undergoing evaluation for liver transplantation
Patient clinically indicated for MRI during transplant candidacy evaluation
Adult
Disqualifiers
None
Trial design
Design model
Single group
Treatments tested in this trial
MAsS
Diagnostic testAdd MAsS to standard of care MRI scan
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: Define MAsS cut-point at transplant evaluation to identify those with high risk for adverse outcomesExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Muscle assessment score (MAsS)
The MAsS is a composite score of muscle fat index (% of muscle fat normalized to sex, weight in kg and height in meters) and muscle volume index (muscle volume in liters normalized to patient sex, height in meters and weight in kg)
Time frame
1 year2
Adverse outcomes
Number of pre- and post-transplant inpatient days
Time frame
1 year3
Adverse outcomes
Number of pre- and post-transplant ICU days
Time frame
1 year4
Adverse outcomes
Number of days alive outside of the hospital in the first year after liver transplant
Time frame
1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Mayo Clinic
Lead sponsor
Amra Medical AB
Collaborator
Source ClinicalTrials.gov