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Donor Specific HLA Alloantibodies in Liver Transplantation
Sponsor: Rigshospitalet, Denmark
Summary
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.
Official title: Donor Specific HLA Alloantibodies in Liver Transplantation: a Prospective Blinded Multicenter Prognostic Study
Key Details
Gender
All
Age Range
Any - Any
Study Type
OBSERVATIONAL
Enrollment
858
Start Date
2015-08-15
Completion Date
2024-12
Last Updated
2024-09-19
Healthy Volunteers
No
Conditions
Interventions
HLA-alloantibodies exposure
Following analyzes will be done: LABScreen® Single Antigen, One Lambda, CA C1qScren™, One Lambda, CA (planned for later study) PE-conjugated IgG3 antibody (planned for later study) LABScreen® Mixed, One Lambda, CA (never analysed in the study)
Locations (5)
Department of Surgical Gastroenterology and Transplantation, Rigshospitalet - Copenhagen University Hospital
Copenhagen, Denmark
Transplantation and Liver Surgery Clinic, Helsinki University Hospital
Helsinki, Finland
Department of Transplantation Medicine, Oslo University Hospital
Oslo, Norway
Surgery Department, Transplantation and Liver Surgery Unit, Sahlgrenska University Hospital
Gothenburg, Sweden
Division of Transplantation Surgery, Karolinska Institutet
Stockholm, Sweden