Status:
UNKNOWN
Evaluation of the Impact of Tacrolimus-based Immunosuppression on Heidelberg Liver Transplant Cohort (HDTACRO): Study Protocol for an Investigator Initiated, Non-interventional Prospective Study
Lead Sponsor:
University Hospital Heidelberg
Conditions:
Liver Transplantation
Eligibility:
All Genders
18-60 years
Brief Summary
Modern immunosuppression is characterized by a combination of different immunosuppressants. As a result, the dose of the individual substances, and thus also their side effects can be reduced. Immunos...
Detailed Description
Tacrolimus is considered a narrow therapeutic index drug requiring individual dose titration, to achieve a satisfactory balance between maximizing efficacy and minimizing dose-related toxicity. The ph...
Eligibility Criteria
Inclusion
- 18 \< Recipient Age ≤ 60 years old
- Ability to understand and sign an informed consent form
- Operation and immediate post-operative therapy within the Department of General, Visceral and Transplantion Surgery, University Hospital Heidelberg
- De novo liver transplantation until POD 7
- Immunosuppression after liver transplantation based on Tacrolimus
Exclusion
- Re-transplantation
- Acute infection of the biliary tract, pneumonia or CMV infection
Key Trial Info
Start Date :
November 22 2018
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 30 2021
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04444817
Start Date
November 22 2018
End Date
December 30 2021
Last Update
June 24 2020
Active Locations (1)
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1
Division of Visceral Transplantation, Department of General, Visceral andTransplantation Surgery, University of Heidelberg
Heidelberg, Baden-Wurttemberg, Germany, 69120