The Liver Transplant Program at the University of North Carolina at Chapel Hill (UNC-CH) is a well-established and vitally important regional resource. This application proposes a multi-center cooperative core study in which a well-defined cohort from UNC-CH and other Transplant Centers (TC) will be followed prospectively to provide reliable, complete, and generalizable information on adult donor and recipient outcomes for both living donor and cadaveric liver transplants. A database structure and information core is proposed, and this application discusses the relevance of each proposed data element. This core study will be augmented by analysis of our historical cohort for which existing outcome data can be pooled across all the Transplant Centers (TC) participating in the Clinical Research Consortium. In addition to these studies, this application proposes two common protocols. The first will examine in-depth the short and long-term morbidity and quality of life of living donors. The second will examine differences in drug metabolism and immunosuppressive regimen between recipients of living donor and cadaveric liver transplants. UNC-CH is well qualified to be a Transplant Center (TC) within the Clinical Research Consortium having performed 13 LDLT in the last 18 months and 21 LDLT total. Projections for UNC-CH are 50-60 CADLT and 15-20 LDLT per year, thereby allowing accrual and followup of more than sufficient numbers of patients to contribute to the Consortium studies. Overall one-year patient and graft survival for both CADLT and LDLT are 90-95% and 77-85% respectively. The UNC-CH infrastructure includes 4 transplant surgeons, 5 hepatologists, and other relevant professionals in vascular surgery, anesthesiology, radiology and vascular/interventional radiology, immunology, infectious disease, pulmonary disease, pathology, pharmacy, nursing, blood bank, psychiatry or psychology and social services. All studies benefit from use of the Verne Caviness General Clinical Research Center (GCRC) as a primary site and collaboration with the Center for Gastrointestinal Biology and Disease (CGIBD). Particularly relevant to this application are the GCRC's Informatics Services and the epidemiologic services of the CGIBD.As a Transplant Center, UNC-CH is committed to close collaborations including membership on the Steering Committee. UNC-CH has participated in multiple multi-center trials and has a rich experiential base in working with data coordinating centers. Our application's strong institutional support for participation as a TC includes acceptance of per patient funding mechanisms for the common protocols.
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