Special Studies

Participation in these studies must be in compliance with your local ethical and patient consent guidelines.

Pre- and Post-Transplant Serum Biomarker Studies

Introduction

Pre- and post-transplant determination of a recipient's risk of graft rejection is a prerequisite for the application of recipient-tailored immunosuppression in organ transplantation. Previous findings indicate that HLA antibodies and T-cell activation marker soluble CD30 (sCD30) are useful parameters for risk estimation. These high molecular weight proteins are not overly sensitive to degradation. Serum samples can therefore be used for research studies even after prolonged frozen storage. Availability of recipient and donor DNA samples is important for the reliable detection of donor-specific antibodies against different HLA and non-HLA loci.

Goal of the study

The goal of the CTS Serum Studies is to elucidate the complex interactions between easily detectable biomarkers and outcome parameters. The outcome measure "graft loss" has become a rare event and several confounders influence the outcome in organ transplantation. It is therefore necessary to study large series of patients. You can also participate only in the "Pre-Transplant Serum Study" or in the "Post-Transplant Serum Study" in which, however, a pretransplant serum is also required to evaluate the impact of de novo antibody development.

Pre- and Post-Transplant Covid-19 Serum Studies

Introduction

In these days, in which we are in another height of the Covid-19 pandemic, many of our patients with end-stage kidney or liver disease and a history of SARS-CoV-2 infection started having access to transplantation and an increasing number of previously transplanted patients are hospitalized for SARS-CoV-2. In the majority of hospitalized patients, anti-proliferative agents and, in more severe cases, also calcineurin inhibitors are withdrawn (Akalin et al. 2020; doi: 10.1056/NEJMc2011117). We hypothesize that such a phase of under-immunosuppression will result in de novo development of DSA and DSA-related inferior outcomes in many patients. Moreover, whether transplantation of patients with a previous SARS-CoV-2 infection is indeed safe must also be demonstrated. Induction with antibodies is avoided in many patients and SARS-CoV-2-mediated activation of the immune system may also support DSA development.

Goal of the Study

In two serum studies we intend to investigate prospectively whether, depending on the severity of disease and alteration of immunosuppression, patients with pre- and post-transplant SARS-CoV-2-infection will develop DSA at a higher rate than matched controls and whether the DSA formation will affect the outcome. Additional aspects we intend to analyze include the influence of blood group and HLA phenotype on the incidence and severity of the Covid-19 disease and the decrease of SARS-CoV-2 antibody levels on the severity of Covid-19 disease. So far, studies addressing these issues have either not been performed or were greatly underpowered. With the Collaborative Transplant Study we have a unique opportunity to collect reliable information on the impact of SARS-CoV-2 infection in transplant recipients within a relatively short time period. Your participation is therefore greatly appreciated.



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