Antibody-mediated rejection in liver transplantation
Research type
Research Study
Full title
A single centre prospective, observational study investigating antibody-mediated rejection in liver transplantation
IRAS ID
138860
Contact name
Kourosh Saeb-Parsy
Contact email
Sponsor organisation
Cambridge University Hospitals NHS Foundation Trust and University of Cambridge
Research summary
This is a single centre prospective study designed to determine the incidence and clinical significance of antibody-mediated rejection (AMR) post liver transplantation. Patients will be recruited at the time of transplantation or at the time of a liver biopsy if the liver transplant occurred before the start point of the study. All previously transplanted patients with existing biopsy samples and serum samples will also be included. Data regarding recipient and donor characteristics and transplant outcomes will be collected.
A blood sample will be taken at the time of transplantation to assess for the presence of pre-formed donor-specific antibodies (DSA). Further serum samples will be taken at 1 week, 1 month, 3 months and 1 year after transplantation; if there is clinical suspicion of liver allograft rejection when a biopsy is performed; or if otherwise clinically indicated. Biopsies will be performed according to current standard practice (e.g., presence of graft dysfunction as indicated by abnormal liver function tests). Biopsy samples will be examined for evidence of rejection and complement deposition as determined by C4d staining. The study will be blinded and samples will be analysed at the end of the study period, unless there is clinical indication to do so earlier.
Patients will be followed up to determine graft function, graft survival and patient survival.
REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
14/EE/0173
Date of REC Opinion
8 Jul 2014
REC opinion
Further Information Favourable Opinion