Status
Conditions
Treatments
About
The aim is to evaluate the impact of donor specific HLA alloantibodies (DSA) on all-cause mortality and re-transplantation, early allograft dysfunction, acute and chronic rejection, fibrosis, vascular, and biliary complications. Furthermore, all biopsies will be C4d stained. The hypothesizes is that donor specific HLA alloantibodies facilitate an immune mediated damage to the liver allograft that impairs function and lead to various complications.
The investigators will do a prospective blinded multicenter cohort study in the Scandiatransplant organ sharing organization region.
Both preformed, persistent, and de novo donor specific HLA alloantibodies will studied. Blood samples will be taken immediately prior to transplantation, and 14 days, 3 months, and 1 year after transplantation. All liver biopsies performed during the study period will be evaluated for a humoral component and blood samples will be obtained prior to liver biopsies to investigate the presence of DSA.
Investigations will be fully blinded for the treatment responsible doctors.
Full description
The outcome after liver transplantation has improved drastically over time, but this development has stagnated in recent years to a graft failure rate of 9-15 % within the first year and approximately 20-30 % at 5 years [1]. The primary goal is to improve the outcome after liver transplantation.
The impact of donor specific antibodies (DSA) on all-cause mortality and re-transplantation, early allograft dysfunction, acute and chronic rejection, vascular and biliary complications and fibrosis will be investigated.
Objectives:
Pediatric patients will be analyzed separately.
In 2021 it was decided to split the study in a preformed and de novo study.
Preformed DSA
Preformed DSA will be analysed in 4 different ways separately for donor specific HLA class I and class II antibodies.
Enrollment
Sex
Volunteers
Inclusion criteria
Exclusion criteria
858 participants in 1 patient group
Loading...
Central trial contact
Carina L Sørensen, BSN; Andreas A Rostved, MD
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal