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

Medical University of Vienna26 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Ischemia Reperfusion Injury

Interventions

TacrolimusDRUG

Immunosuppression, intraoperative intraportal infusion of 1ml Tacrolimus with a concentration of 20 ug/mL

Saline solution 0.9% (250mL)OTHER

intraoperative intraportal infusion of Saline solution 0.9% (250mL)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

General Hospital Vienna

Vienna, Austria

Outcomes

Primary Outcomes

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.

Time frame: Day 1,2,3; Weeks 6 and 12 post OLT