Antibodies and Liver Retransplantation

Overview

Despite reports that associate donor specific antibody (DSA) with rejection after liver transplantation, grafts are still allocated according to blood group (ABO) but not human leukocyte antigen (HLA) compatibility, possibly due to the absence of an easily discernible clinical association between adverse recipient outcome and DSA. Re-transplantation provides a test environment where the presence of preformed DSA or other antibodies is prevalent and events (graft loss) more common so that the effect of these antibodies on outcome should be apparent. This is an observational study of routine clinical care to determine these effects on our own patients. The goal is to perfect donor-recipient matching to attain the best outcome. In addition, we may develop hypotheses and potential treatments that would be tested in further clinical trials

Full Title of Study: “Role of Donor Specific Antibodies, Other Anti-human Leucocyte Antibodies and Autoantibodies in the Outcome of Liver Retransplantation”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Retrospective
  • Study Primary Completion Date: January 1, 2021

Detailed Description

Despite reports that associate donor specific antibody (DSA) with rejection after liver transplantation, grafts are still allocated according to blood group (ABO) but not human leukocyte antigen (HLA) compatibility, possibly due to the absence of an easily discernible clinical association between adverse recipient outcome and DSA. Re-transplantation provides a test environment where the presence of preformed DSA or other antibodies is prevalent and events (graft loss) more common so that the effect of these antibodies on outcome should be apparent. This is an observational study of routine clinical care to determine these effects on our own patients. In phase 1, we will examine the effect of antibodies specifically directed against the second donor in liver retransplantation. Other factors known to effect the outcome will be checked to allow for risk adjustment. In phase 2, we will examine the role played by specific auto-antibodies such as angiotensin II receptor type 1 antibodies and endothelin-1 type A receptor antibodies on the outcome of liver retransplantation. The goal of these observational study is to perfect donor-recipient matching to attain the best outcome. In addition, we may develop hypotheses and potential treatments that would be tested in further clinical trials.

Interventions

  • Diagnostic Test: Luminex-based solid phase assay of banked sera for anti-HLA antibodies directed against the donor of a second liver transplantation
    • Anti-AT1R antibodies were tested on pre-transplantation sera using ELISA kit (Lot #30, One Lambda, Canoga Park, CA)

Arms, Groups and Cohorts

  • D2SA+
    • Median fluoresce intensity > or = 1000 on Luminex-based solid phase assay of banked sera for anti-HLA antibodies directed against the donor of a second liver transplantation
  • D2SA-
    • Median fluoresce intensity < 1000 on Luminex-based solid phase assay of banked sera for anti-HLA antibodies directed against the donor of a second liver transplantation

Clinical Trial Outcome Measures

Primary Measures

  • Retransplant graft survival
    • Time Frame: From date of transplantation until the date of next transplantation or date of death from any cause, whichever came first, assessed up to 240 months
    • Average length of time the second liver graft remains in a living recipient regardless of function

Secondary Measures

  • Patient survival
    • Time Frame: From date of transplantation until the date of death from any cause assessed up to 240 months
    • Average length of time a recipient is alive regardless of presence of the second liver transplant

Participating in This Clinical Trial

Inclusion Criteria

  • Recipients of a second liver transplantation performed at LHSC Exclusion Criteria:

  • Recipients of ABO incompatible second liver transplantation – Recipients of multiple organs

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • London Health Sciences Centre
  • Provider of Information About this Clinical Study
    • Principal Investigator: Vivian McAlister, Professor of Surgery – London Health Sciences Centre
  • Overall Official(s)
    • Vivian McAlister, Principal Investigator, London Health Sciences Center

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