N/A
Completed N=86
Evaluation of Preimplantation Portal Vein and Hepatic Artery Flushing With Tacrolimus
Early Allograft Dysfunction · Ischemic Reperfusion Injury · Liver Transplantation · Hyperfibrinolysis
Source: ClinicalTrials.gov NCT01887171 ↗
Enrolled (actual)
86
Serious AEs
82.4%
Results posted
Feb 2017
Primary outcomePrimary: Early Allograft Dysfunction — 6; 18 Participants
Summary
The purpose of this study is to determine whether the Tacrolimus added to histidine-tryptophan-ketoglutarate (HTK) solution given through intraportal and intraarterial infusion during back-table procedure is capable of reducing the degree of early allograft liver dysfunction, as assessed by postoperative levels of aspartate aminotransferase (AST), alanine aminotransferase (ALT), during first 7 postoperative days and by serum and histochemical markers of liver injury and inflammation.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Early Allograft Dysfunction |
6; 18 | — |
| SECONDARY Ischemic Reperfusion Injury of the Liver Allograft |
— | — |
| SECONDARY Inflammatory Response to Reperfusion |
— | — |
| SECONDARY Postreperfusion Hyperfibrinolysis |
— | — |
Eligibility Criteria
Inclusion Criteria
- Donor:
age 15-65 years macrovesicular steatosis < 40% (macroscopy or biopsy) sodium <165 mmol/l ICU stay and ventilation < 11 days cold ischemia time < 13 hours AST < 200 U/l ALT < 200 U/l bilirubin < 50 μmol/l application of norepinephrine is allowed
- Recipient age: 18-69
Exclusion Criteria
Recipient:
- live donor liver transplant
- reduced and split grafts
- multi organ failure
Data sourced from ClinicalTrials.gov (NCT01887171). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.