The effect of Tacrolimus (Prograf®) during the implantation on ischemia-reperfusion injury in orthotopic liver transplant recipients
Conditions
Interventions
Trade Name: Progaf
Product Name: Prograf
Pharmaceutical Form: Capsule, soft
Pharmaceutical form of the placebo: Intravenous infusion
Route of administration of the placebo: Intravenous use
Sponsors
Medizinische Universität Wien; Univ.Klin.f. Chirurgie; Klin. Abtlg. f. Transplantation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria - Patients, who are listed on the liver transplant-waiting list at the Vienna General Hospital and who fulfil the clinical requirements (local allocation) - Written informed consent - Age > 18 - First transplantation Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion criteria - Fulminant failure of the liver - Liver-Living donor recipients - Multiorgantransplantation or retransplantation - ABO incompatible donor organ recipients - pregnant or nursing women - Allergy/Intolerance to antimetaboliten, HCO-60, EL Cremophor or similar compounds Steroids or Macrolid antibiotics - HIV-positive donors or recipients - Participants of another clinical study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: protective effect of Tacrolimus on ischemia-reperfusion injury in orthotopic liver transplant recipients parameters of the liver function (LFP): AST (U/L), ALT (U/L), total Bilirubin (mg/dL) and the coagulation factors: NT (%), PTT (s), INR.;Secondary Objective: - Serum parameters: TNF alpha, IL1, IL6 - Histopathology (before and after reperfusion) - Frequency of rejection episodes - Graft function (Serum) und graft survival at 3 months post Tx - Patient survival at 3 months post Tx ;Primary end point(s): 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. | — |
Countries
Austria
Outcome results
None listed