PROJECT SUMMARY
The American Consortium of Early Liver Transplantation-Prospective Alcohol-associated liver disease Cohort
Evaluation (ACCELERATE-PACE) study is a prospective longitudinal cohort of patients with severe alcohol-
associated liver disease (ALD) evaluated for early liver transplantation (ELT). The cohort leverages the
ACCELERATE consortium with 4-linked R01s and 5 additional recruitment sites in the South/Southeast, Mid-
Atlantic, Midwest, and West, and will refine and identify best practices in the selection and management of
patients with severe ALD considered for ELT across their continuum of care. ALD is now the most common
indication for liver transplantation (LT) in the U.S. Historically, LT centers required at least 6 months of alcohol
abstinence before LT referral and evaluation, though empiric evidence to support minimum sobriety periods was
limited. ELT, defined as LT before 6 months of abstinence, is increasingly performed but with significant practice
variability. There is no consensus on optimal ELT candidate selection, and selection criteria vary widely,
contributing to disparities in access to lifesaving care. ELT is also controversial due to the potential for liver
recompensation with abstinence, which would obviate the need for LT—accurate prediction of recompensation
has the potential to increase organ utility and stewardship. Detailed evaluation of the efficacy of alcohol use
disorder treatments and improved risk scores based on pre-LT psychosocial factors to predict return to alcohol
use are needed to refine selection criteria, optimize post-LT care, and effectively treat AUD. Short- and
intermediate-term survival after ELT is excellent, but the incidence and predictors of post-LT complications are
poorly defined. To fill these key knowledge gaps, we will enroll and prospectively follow 770 ELT
candidates and 270 ELT recipients for 3 years at 9 socio-demographically diverse centers. The proposed
Aims will: (i) inform ELT selection criteria and investigate potential sources of bias in ELT evaluation and
healthcare disparities in ELT access; (ii) develop risk prediction scores for LT-free survival and recompensation;
(iii) identify effective treatments (medical, behavioral) for alcohol use disorder among patients with severe ALD
and post-ELT; (iv) evaluate clinical outcomes among ELT candidates and recipients, including mortality,
transplantation, post-LT complications (e.g. cancer, cardiovascular events, graft rejection/failure), and quality of
life. A comprehensive data repository will include sociodemographic, clinical, geospatial, psychosocial,
behavioral, and patient-reported outcome variables. LT documents, checklists, recordings of selection meetings,
direct observations of LT procedures, and clinician interviews will identify best practices and pitfalls in candidate
selection. A biorepository of blood, urine, explant/donor tissue, pre- and post-LT liver tissue, peripheral blood
mononuclear cells, and cross-sectional radiologic imaging will inform future ancillary studies.
