Overview

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.