TOP-Study (Tacrolimus Organ Perfusion): Treatment of Ischemia Reperfusion Injury in Marginal Organs With an ex Vivo Tacrolimus Perfusion

• Status: Terminated
• Trial end date: 2013-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ludwig-Maximilians - University of Munich
• Treatments: Pharmaceutical Solutions; Tacrolimus; Tryptophan

Criteria

Inclusion Criteria:

Recipient:

Chronical terminal liver failure, age > 18 years, first organ transplantation

Donor:

• donor age > 65 Jahre

• macrovesicular steatosis > 40% (macroscopy or biopsy)

• BMI > 30

• sodium >165 mmol/l

• ICU stay and ventilation > 7 days

• cold ischemia time > 13 hours

• AST > 99 U/l

• ALT > 105 U/l

• bilirubin > 3 mg/dl (> 51 µmol/l)

• application of epinephrine

Exclusion Criteria:

Donor:

• Hepatitis B- or Hepatitis C-infection

Recipient:

• Multi organ transplantation

• high urgency listing

• extrahepatic tumor disease

• pregnancy