Graft Rejection or Tolerance Affected by Serial Change of Anti-donor Lymphocyte Antibody After Liver Transplantation
Recruitment status was Recruiting
Liver is an organ that is well-known for its immune tolerant capacity. However, there were still controversial issues about the impact of immunologic challenge after liver transplantation on the graft function. Different results of graft function affected by immunologic factors such as pre-transplant panel reactive antibody (PRA) status, pre-transplant positive lymphocyte cross match (LCM), or post-transplant circulating donor specific antibody (DSA) has been reported according to individual institutes. There was no trial for presenting anti-donor lymphocyte antibody change after liver transplantation.
The investigators designed this study to analyze the correlation between pre- and post-transplant immune status (PRA, LCM), and graft survival / rejection episode. Also, the investigators will find aspects of anti-donor lymphocyte antibody change after liver transplantation.
Liver Transplant Rejection
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Graft Rejection or Tolerance Affected by Serial Change of Anti-donor Lymphocyte Antibody After Liver Transplantation|
- incidence of acute rejection [ Time Frame: Time point when patients are diagnosed acute rejection ] [ Designated as safety issue: No ]We designed to analyze the aspects of acute rejection between anti-donor lymphocyte antibody change liver transplantation.
- correlation between pre- and post-transplant immune status (PRA, LCM), and graft survival [ Time Frame: at 7 day, 14 day, 21 day after transplantation and at 3 month, 6 month after transplantation ] [ Designated as safety issue: No ]We designed this study to analyze the correlation between pre- and post-transplant immune status (PRA, LCM), and graft survival / rejection episode.
Biospecimen Retention: None Retained
Whole blood (serum)
|Study Start Date:||April 2011|
|Estimated Study Completion Date:||March 2013|
|Estimated Primary Completion Date:||March 2013 (Final data collection date for primary outcome measure)|
Liver transplant recipients
Recipients who will undergo liver transplantation during study period
Study Design: Target study population is forty patients who will undergo liver transplantation for 1 year in YUHS. Pediatric and early mortality cases will be excluded. Blood sample will be collected at pre-transplant period, post-transplant 7, 14, 21 day, 3 month and 6 month.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01444079
|Contact: Myoung Soo Kim, MD, PhDemail@example.com|
|Korea, Republic of|
|Seoul, Korea, Republic of, 120-752|
|Contact: Dong Jin Joo 82-2-2228-2105 firstname.lastname@example.org|
|Principal Investigator:||Myoung Soo Kim, M.D.||Yonsei University College of Meidicine|