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ACTIVE NOT RECRUITING
NCT02784080

Donor Specific HLA Alloantibodies in Liver Transplantation

Sponsor: Rigshospitalet, Denmark

View on ClinicalTrials.gov

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

Interventions

OTHER

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