Graft Rejection or Tolerance Affected by Serial Change of Anti-donor Lymphocyte Antibody After Liver Transplantation

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01444079

Enrollment

Registered

2011-09-30

Start date

2011-04-30

Completion date

2014-02-28

Last updated

2015-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Transplant Rejection

Keywords

Liver transplantation, Rejection, Tolerance

Brief summary

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.

Detailed description

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

20 Years to 70 Years

Healthy volunteers

Inclusion criteria

* Liver recipients who undergo liver transplantation between Mar, 2011 and Feb, 2012 * Patients who can be followed for more than 3 months after transplantation

Exclusion criteria

* Age under 20 years * Multi-organ transplantation * Not agree with informed consent * Patient who had plant to be transferred to other country or center

Design outcomes

Primary

Measure	Time frame	Description
incidence of acute rejection	Time point when patients are diagnosed acute rejection	We designed to analyze the aspects of acute rejection between anti-donor lymphocyte antibody change liver transplantation.

Secondary

Measure	Time frame	Description
correlation between pre- and post-transplant immune status (PRA, LCM), and graft survival	at 7 day, 14 day, 21 day after transplantation and at 3 month, 6 month after transplantation	We designed this study to analyze the correlation between pre- and post-transplant immune status (PRA, LCM), and graft survival / rejection episode.

Countries

South Korea

Outcome results