Status:
COMPLETED
Tacrolimus During the Implantation and the Effect on Ischemia-reperfusion Injury in Liver Transplantation
Lead Sponsor:
Medical University of Vienna
Conditions:
Ischemia Reperfusion Injury
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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:...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2010
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT00609388
Start Date
January 1 2008
End Date
December 1 2010
Last Update
December 8 2010
Active Locations (1)
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1
General Hospital Vienna
Vienna, Austria, 1090