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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Active Comparator | Group A receives an intraportal Tacrolimus-infusion, ATG Induction, Tacrolimus and Steroids. |
|
| B | Placebo Comparator | Group B receives a placebo-Saline solution (0.9%)-Infusion, ATG induction, Tacrolimus and Steroids. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tacrolimus | Drug | Immunosuppression, intraoperative intraportal infusion of 1ml Tacrolimus with a concentration of 20 ug/mL |
|
| Measure | Description | 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 |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Martin Bodingbauer, MD | Medical University of Vienna | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| General Hospital Vienna | Vienna | 1090 | Austria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12548508 | Result | 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. | |
| 21672049 | Derived | 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. |
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| ID | Term |
|---|---|
| D015427 | Reperfusion Injury |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D016559 | Tacrolimus |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D000077324 | Crystalloid Solutions |
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| Saline solution 0.9% (250mL) | Other | intraoperative intraportal infusion of Saline solution 0.9% (250mL) |
|
| 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 |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007552 |
| Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |