Diabetes Mellitus Clinical Trial
Official title:
A Prospective Randomized Multicenter Trial Comparing Histidine-Tryptophane-Ketoglutarate (HTK) Versus University of Wisconsin (UW) Perfusion Solution in Clinical Pancreas Transplantation
Graft preservation in clinical pancreas transplantation is based on hypothermia achieved by
topic cooling and cold in situ flushing using special perfusion solutions designed to
attenuate the effects of ischemia/reperfusion and prolong cold ischemia tolerance.
For pancreas transplantation, University of Wisconsin (UW) solution is the most commonly
used perfusate. However, over the last years, Histidine-Tryptophan-Ketoglutarate (HTK)
solution has been increasingly used for abdominal organ procurement. Retrospective reports
published so far have demonstrated the safety of both perfusion solutions.
However, to date, no prospective study comparing both perfusion solutions has been
published. Aim of this study was to prospectively evaluate early pancreas graft function in
clinical pancreas transplantation after organ perfusion with HTK vs. UW solution.
The study hypothesis is that HTK is not inferior to UW for organ perfusion during
procurement in clinical pancreas transplantation.
n/a
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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