Tacrolimus During the Implantation and the Effect on Ischemia-reperfusion Injury in Liver Transplantation (TAC-Infusion)

Medical University of Vienna

Status and phase

Completed

Phase 4

Conditions

Ischemia Reperfusion Injury

Treatments

Other: Saline solution 0.9% (250mL)

Drug: Tacrolimus

Study type

Interventional

Funder types

Other

Identifiers

NCT00609388

TX 001/07

Details and patient eligibility

About

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.

Enrollment

26 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.