Reduktion des Ischämie-Reperfusionsschadens durch ex-vivo Tacrolimus-Perfusion marginaler Organe vor Lebertransplantation (Tacrolimus-Organ-Perfusion TOP-Studie)

• Conditions: Chonical terminal liver insufficiency; MedDRA version: 14.1Level: PTClassification code 10024714Term: Liver transplantSystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]

• Registration Number: EUCTR2010-021333-31-DE
• Lead Sponsor: Klinikum der Universität München

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06-14
• Last Update Posted: 2 September 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified