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Donor Specific HLA Alloantibodies in Liver Transplantation

NCT02784080 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 858

Last updated 2024-09-19

No results posted yet for this study

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.

Conditions

  • Complication of Transplanted Liver

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)

Sponsors & Collaborators

  • Sahlgrenska University Hospital

    collaborator OTHER

  • Karolinska Institutet

    collaborator OTHER

  • Helsinki University Central Hospital

    collaborator OTHER

  • Oslo University Hospital

    collaborator OTHER

  • Rigshospitalet, Denmark

    lead OTHER

Principal Investigators

  • Allan Rasmussen, MD · Department of Surgical Gastroenterology and Transplantation, Rigshospitalet - Copenhagen University Hospital, Denmark

  • Andreas A Rostved, MD · Department of Surgical Gastroenterology and Transplantation, Rigshospitalet - Copenhagen University Hospital, Denmark

  • Helle Bruunsgaard, MD, DMSc · Department of Clinical Immunology, Centre of Diagnostic Investigation, Rigshospitalet - Copenhagen University Hospital

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-15
Primary Completion
2024-09-30
Completion
2024-12-31

Countries

  • Denmark
  • Finland
  • Norway
  • Sweden

Study Locations

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Entities

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02784080 on ClinicalTrials.gov