Ischemia Reperfusion Injury
Conditions
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.
Interventions
DRUGTacrolimus
Immunosuppression, intraoperative intraportal infusion of 1ml Tacrolimus with a concentration of 20 ug/mL
OTHERSaline solution 0.9% (250mL)
intraoperative intraportal infusion of Saline solution 0.9% (250mL)
Sponsors
Medical University of Vienna
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
| Patient survival at 3 months post Tx | within the first 3 month |
Countries
Austria
Outcome results
None listed