A Phase 2/3 interventional study of Tacrolimus and HTK/Placebo in Terminal Liver Disease, Ischemia Reperfusion Injury and Graft Dysfunction, sponsored by Ludwig-Maximilians - University of Munich. Terminated at 7 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-03-23.
Sponsored by Ludwig-Maximilians - University of Munich · Phase 2/3, Interventional, and Treatment
Utilisation of extended criteria donors due to critical organ shortage contributes to increased ischemia reperfusion injury as well as mortality following liver transplantation. Experimental data show protective effects on hepatic ischemia reperfusion injury (IRI) using the calcineurin inhibitor Tacrolimus applied intravenously or directly as a hepatic rinse. Moreover clinical data indicate a protective role of a Tacrolimus rinse in human liver transplantation when using normal, healthy grafts. The effects of Tacrolimus on hepatic injury in extended donor criteria (EDC) liver grafts remain unclear. Therefore, the aim of the present study is to examine the effects of a Tacrolimus ex vivo rinse (20 ng/ml) on cellular injury after transplantation of marginal liver grafts exhibiting 2 or more EDCs according to Eurotransplant's definition of EDC grafts.
2,081 studies on the registry are indexed under Liver Diseases; 390 are open to participants now.
This study's enrollment of 25 is below the median of 50 across 1,323 interventional studies indexed under Liver Diseases.
Browse Liver Diseases studies →Ludwig-Maximilians - University of Munich is the lead sponsor of 218 studies on the registry; 29 are open to participants now.
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Recipient:
Chronical terminal liver failure, age > 18 years, first organ transplantation
Donor:
Exclusion Criteria:
Donor:
Recipient:
Ex vivo Tacrolimus Rinse (20 ng/ml solved in 1000 ml HTK) of marginal liver grafts prior to implantation
Drug: Tacrolimus
Ex vivo Rinse (1000 ml HTK) of marginal liver grafts prior to implantation
Drug: HTK/Placebo
Marginal liver grafts are flushed with Tacrolimus (20ng/ml) solved in 1000 ml HTK preservation solution (duration: 15 min) ex vivo at the end of backtable preparation in the experimental group.
Also known as: Tacrolimus, Prograf; Astellas Germany, HTK, histidin-tryptophane-ketoglurate organ preservation solution, Custodiol, Dr. Franz Köhler Chemie, Germany
Marginal liver grafts are flushed with 1000 ml HTK preservation solution(duration: 15 min) ex vivo at the end of backtable preparation in the placebo group.
Also known as: HTK, histidin-tryptophane-ketoglurate organ preservation solution, Custodiol, Dr. Franz Köhler Chemie, Germany
Maximum serum ALT-level
Time frame: 48 hrs following liver transplantation
ALT
Time frame: 1,2,4,7 days after surgery
Graft survival
Time frame: 7 days
AST
Time frame: 1,2,4,7 days after surgery
Bilirubin
Time frame: 1,2,4,7 days after surgery
Creatinin
Time frame: 1,2,4,7 days after surgery
Plan to share: No
This study is terminated, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.
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Ludwig-Maximilians - University of Munich