We propose to develop and maintain a Data Coordinating Center (DCC) to support the Adult to Adult Living Donor Liver Transplantation (AALDLT) Cohort Study including a Specimen Core Facility. The proposed AALDLT DCC will be comprised of multidisciplinary expertise in liver transplantation, biostatistics, epidemiology, clinical trials, and data management. We will develop a secure, integrated Internet-based data entry and data management system to support data and specimen acquisition. The AALDLT DCC will coordinate the design and implementation of the AALDLT cohort study and clinical protocols and will provide support in the relevant content areas to the Steering Committee and the NIDDK in its effort to accomplish the primary goal of conducting a longitudinal study of the recipients and donor outcomes in AALDLT. The DCC will accomplish the foregoing goals through the implementation of the following specific aims: 1. Design, organize, implement and coordinate a secure electronic, centralized web-based distributed data entry system for the participating transplant centers (TCs) 2. Establish a secure data management and archival system for the AALDLT cohort study, clinical protocols and substudies 3. Develop comprehensive, valid data collection instruments4. Establish a high standard, quality-assured central repository for biological specimens acquired from AALDLT donors, recipients, and controls5. Perform methodologically rigorous analyses of AALDLT data 6. Facilitate the presentation, dissemination and publication of the results of the AALDLT study. 7. Organize, schedule and manage the meetings, conferencing and communication of the Steering Committees, subcommittees, the DSMB and the central laboratories involved in the AALDLT study. 8. Provide timely and effective communication among the NIDDK project officer and project scientists, DCC, and participating TCs regarding all aspects of the AALDLT study to ensure the fulfillment of the programs scientific goals.

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
Research Project--Cooperative Agreements (U01)
Project #
5U01DK062498-07
Application #
7498413
Study Section
Special Emphasis Panel (ZDK1-GRB-D (M1))
Program Officer
Everhart, James
Project Start
2002-08-21
Project End
2009-08-31
Budget Start
2008-08-01
Budget End
2009-08-31
Support Year
7
Fiscal Year
2008
Total Cost
$1,256,259
Indirect Cost
Name
University of Michigan Ann Arbor
Department
Surgery
Type
Schools of Medicine
DUNS #
073133571
City
Ann Arbor
State
MI
Country
United States
Zip Code
48109
Dew, Mary Amanda; Butt, Zeeshan; Liu, Qian et al. (2018) Prevalence and Predictors of Patient-Reported Long-term Mental and Physical Health After Donation in the Adult-to-Adult Living-Donor Liver Transplantation Cohort Study. Transplantation 102:105-118
Butt, Zeeshan; DiMartini, Andrea F; Liu, Qian et al. (2018) Fatigue, Pain, and Other Physical Symptoms of Living Liver Donors in the Adult-to-Adult Living Donor Liver Transplantation Cohort Study. Liver Transpl 24:1221-1232
Butt, Z; Dew, M A; Liu, Q et al. (2017) Psychological Outcomes of Living Liver Donors From a Multicenter Prospective Study: Results From the Adult-to-Adult Living Donor Liver Transplantation Cohort Study2 (A2ALL-2). Am J Transplant 17:1267-1277
Levitsky, Josh; Goldberg, David; Smith, Abigail R et al. (2017) Acute Rejection Increases Risk of Graft Failure and Death in Recent Liver Transplant Recipients. Clin Gastroenterol Hepatol 15:584-593.e2
DiMartini, A; Dew, M A; Liu, Q et al. (2017) Social and Financial Outcomes of Living Liver Donation: A Prospective Investigation Within the Adult-to-Adult Living Donor Liver Transplantation Cohort Study 2 (A2ALL-2). Am J Transplant 17:1081-1096
Baker, Talia B; Zimmerman, Michael A; Goodrich, Nathan P et al. (2017) Biliary reconstructive techniques and associated anatomic variants in adult living donor liver transplantations: The adult-to-adult living donor liver transplantation cohort study experience. Liver Transpl 23:1519-1530
Emond, Jean C; Goodrich, Nathan P; Pomposelli, James J et al. (2017) Hepatic Hemodynamics and Portal Flow Modulation: The A2ALL Experience. Transplantation 101:2375-2384
Mandell, M Susan; Smith, Abigail R; Dew, Mary Amanda et al. (2016) Early Postoperative Pain and its Predictors in the Adult to Adult Living Donor Liver Transplantation Cohort Study. Transplantation 100:2362-2371
Dew, Mary Amanda; DiMartini, Andrea F; Ladner, Daniela P et al. (2016) Psychosocial Outcomes 3 to 10 Years After Donation in the Adult to Adult Living Donor Liver Transplantation Cohort Study. Transplantation 100:1257-69
Samstein, B; Smith, A R; Freise, C E et al. (2016) Complications and Their Resolution in Recipients of Deceased and Living Donor Liver Transplants: Findings From the A2ALL Cohort Study. Am J Transplant 16:594-602

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