Tacrolimus During the Implantation and the Effect on Ischemia-reperfusion Injury in Liver Transplantation
Phase 4
Completed
- Conditions
- Ischemia Reperfusion Injury
- Interventions
- Other: Saline solution 0.9% (250mL)
- Registration Number
- NCT00609388
- Lead Sponsor
- Medical University of Vienna
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 26
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description B Saline solution 0.9% (250mL) Group B receives a placebo-Saline solution (0.9%)-Infusion, ATG induction, Tacrolimus and Steroids. A Tacrolimus Group A receives an intraportal Tacrolimus-infusion, ATG Induction, Tacrolimus and Steroids.
- Primary Outcome Measures
Name Time Method 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. Day 1,2,3; Weeks 6 and 12 post OLT
- Secondary Outcome Measures
Name Time Method Patient survival at 3 months post Tx within the first 3 month Serum parameters: TNF alpha, IL1, IL6 within the first 3 month Histopathology (before and after reperfusion) within the first 3 month Frequency of rejection episodes within the first 3 month Graft function (Serum) und graft survival at 3 months post Tx within the first 3 month
Trial Locations
- Locations (1)
General Hospital Vienna
🇦🇹Vienna, Austria