Chonical terminal liver insufficiency MedDRA version: 14.1 Level: PT Classification code 10024714 Term: Liver transplant System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Interventions
Trade Name: Prograf
Product Name: Prograf
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: TACROLIMUS
CAS Number: 104987-11-3
Concentration unit: mg/ml milligram(s)/mill
Sponsors
Klinikum der Universität München
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Donor:organ donor with at least two of the following marginality criteria (according to Eurotransplant manual Extnded Criteria Liver Conors, 09/03/2009): donors age>65 macro vesicular steatosis >40% Na> 165 mmol/l intensive care and ventilation >7 days BMI >30 cold ischemia time >13 hours GPT>105 U/l GOT >99 U/l Bilirubin >3mg/dl Bilirubin (> 51 µmol/l) giving of adrenaline Recipient: listing for a liver transplantation at one of the participating sites first liver transplantation age >18 years signed informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 82 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 4
Exclusion criteria
Exclusion criteria: Donor: at least one of the following riskfactors: active hepatitis B-or hepatitis C-infection Recipient: multi organ transplant HU listing Extra hepatic tumor disease pregnancy refusal or withdrawal of the patient or their relatives institutionalization based on official order or court order missing or lacking knowledge of german, so that the understanding of the written patient information is not guaranteed
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: highest measured GPT level on the first two postoperative days;Secondary Objective: GPT, GOT postoperative on day 1,2,4,7 function of the graft (Quick-Test, Bilirubin) organ- and patient survival biopsy verified refection;Primary end point(s): maximum of the hepatocellular damage within the first 48 hoursof the liver transplantation. The damage will be qualified by GPT;Timepoint(s) of evaluation of this end point: postoperative day 1 and 2 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): GPT, Got postoperative on day 1,2,4,7 function of the transplant(Quick-Test, Bilirubin) Organ-and Patient survival biopsy verified rejection;Timepoint(s) of evaluation of this end point: postoperative day 1,2,4,7 | — |
Countries
Germany
Contacts
Public ContactProf. Dr. Angele
Klinikum der Universität München
Outcome results
None listed