Tacrolimus During the Implantation and the Effect on Ischemia-reperfusion Injury in Liver Transplantation

• Status: Completed
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The evaluation of the efficacy of an intraportal infusion with Tacrolimus, at the time of liver graft implantation, compared to a control group without immunosuppressive intraportal infusion (Placebo: Saline solution 0.9%) with respect to the initial liver function measured by the parameters of the liver function (LFP): AST (U/L), ALT (U/L), total Bilirubin (mg/dL) and the coagulation factors: NT (%), PTT (s), INR.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical University of Vienna
• Treatments: Pharmaceutical Solutions; Tacrolimus

Criteria

Inclusion Criteria:

• Multi organ transplantation or retransplantation

• ABO incompatible donor organ recipients- Patients, who are listed on the liver transplant-waiting list at the Vienna General Hospital and who fulfill the clinical requirements (local allocation)

• Written informed consent

• Age > 18

• First transplantation

Exclusion Criteria:

• Fulminant failure of the liver

• Liver-Living donor recipients

• pregnant or nursing women

• Allergy/Intolerance to antimetabolites, HCO-60, EL Cremophor or similar compounds,Steroids or macrolide antibiotics

• HIV-positive donors or recipients

• Participants of another clinical study

• Patient has any form of substance abuse, psychiatric disorder or condition, which, in the opinion of the investigator, may invalidate communication.