Clinical trial NCT00609388: Tacrolimus During the Implantation and the Effect on Ischemia-reperfusion Injury in Liver Transplantation
Official title: Evaluation of Tacrolimus (Prograf®) Intraportal Infusion During the Implantation and the Protective Effect on Ischemia-reperfusion Injury in Orthotopic Liver Transplant Recipients - Single Center Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Ischemia Reperfusion Injury
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2008-02-07
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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.

Primary outcomes:
measure: 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.
timeFrame: Day 1,2,3; Weeks 6 and 12 post OLT
Secondary outcomes:
measure: Serum parameters: TNF alpha, IL1, IL6
timeFrame: within the first 3 month
measure: Histopathology (before and after reperfusion)
timeFrame: within the first 3 month
measure: Frequency of rejection episodes
timeFrame: within the first 3 month
measure: Graft function (Serum) und graft survival at 3 months post Tx
timeFrame: within the first 3 month
measure: Patient survival at 3 months post Tx
timeFrame: within the first 3 month
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: General Hospital Vienna
Study officials:
affiliation: Medical University of Vienna
name: Martin Bodingbauer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: St Peter SD, Post DJ, Rodriguez-Davalos MI, Douglas DD, Moss AA, Mulligan DC. Tacrolimus as a liver flush solution to ameliorate the effects of ischemia/reperfusion injury following liver transplantation. Liver Transpl. 2003 Feb;9(2):144-9. doi: 10.1053/jlts.2003.50018.
citation: Kristo I, Wilflingseder J, Kainz A, Marschalek J, Wekerle T, Muhlbacher F, Oberbauer R, Bodingbauer M. Effect of intraportal infusion of tacrolimus on ischaemic reperfusion injury in orthotopic liver transplantation: a randomized controlled trial. Transpl Int. 2011 Sep;24(9):912-9. doi: 10.1111/j.1432-2277.2011.01284.x. Epub 2011 Jun 14.