TOP-Study (Tacrolimus Organ Perfusion): Treatment of Ischemia Reperfusion Injury in Marginal Organs With an ex Vivo Tacrolimus Perfusion
NCT ID: NCT01564095
Last Updated: 2017-03-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2/PHASE3
25 participants
INTERVENTIONAL
2011-10-31
2013-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Tacrolimus + HTK
Ex vivo Tacrolimus Rinse (20 ng/ml solved in 1000 ml HTK) of marginal liver grafts prior to implantation
Tacrolimus
Marginal liver grafts are flushed with Tacrolimus (20ng/ml) solved in 1000 ml HTK preservation solution (duration: 15 min) ex vivo at the end of backtable preparation in the experimental group.
HTK
Ex vivo Rinse (1000 ml HTK) of marginal liver grafts prior to implantation
HTK/Placebo
Marginal liver grafts are flushed with 1000 ml HTK preservation solution(duration: 15 min) ex vivo at the end of backtable preparation in the placebo group.
Interventions
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Tacrolimus
Marginal liver grafts are flushed with Tacrolimus (20ng/ml) solved in 1000 ml HTK preservation solution (duration: 15 min) ex vivo at the end of backtable preparation in the experimental group.
HTK/Placebo
Marginal liver grafts are flushed with 1000 ml HTK preservation solution(duration: 15 min) ex vivo at the end of backtable preparation in the placebo group.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Chronical terminal liver failure, age \> 18 years, first organ transplantation
Donor:
* donor age \> 65 Jahre
* macrovesicular steatosis \> 40% (macroscopy or biopsy)
* BMI \> 30
* sodium \>165 mmol/l
* ICU stay and ventilation \> 7 days
* cold ischemia time \> 13 hours
* AST \> 99 U/l
* ALT \> 105 U/l
* bilirubin \> 3 mg/dl (\> 51 µmol/l)
* application of epinephrine
Exclusion Criteria
• Hepatitis B- or Hepatitis C-infection
Recipient:
* Multi organ transplantation
* high urgency listing
* extrahepatic tumor disease
* pregnancy
18 Years
ALL
No
Sponsors
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Ludwig-Maximilians - University of Munich
OTHER
Responsible Party
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Prof. Dr. M. Angele
Prof. Dr. med. Martin Angele
Principal Investigators
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Martin Angele, M.D.
Role: PRINCIPAL_INVESTIGATOR
Ludwig-Maximilians-University, Department of Surgery, Munich, Germany
Sebastian Pratschke, M.D.
Role: STUDY_DIRECTOR
Ludwig-Maximilians-University, Department of Surgery, Munich, Germany
Karl-Walter Jauch, M.D.
Role: STUDY_CHAIR
Ludwig-Maximilians-University, Department of Surgery, Munich, Germany
Locations
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Department of General, Visceral and Transplantation Surgery, Charité Campus Virchow-Klinikum
Berlin, , Germany
Department of General and Visceral Surgery, Johann Wolfgang Goethe-University
Frankfurt am Main, , Germany
Department of General, Visceral and Transplantation Surgery, Ruprecht Karls University
Heidelberg, , Germany
Department of Transplantation Surgery, Johannes Gutenberg University
Mainz, , Germany
Ludwig-Maximilians University, Campus Grosshadern, Department of Surgery
Munich, , Germany
Department of Surgery, University of Regensburg
Regensburg, , Germany
Department of General, Visceral and Transplantation Surgery, Eberhard Karls University
Tübingen, , Germany
Countries
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References
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Pratschke S, Bilzer M, Grutzner U, Angele M, Tufman A, Jauch KW, Schauer RJ. Tacrolimus preconditioning of rat liver allografts impacts glutathione homeostasis and early reperfusion injury. J Surg Res. 2012 Jul;176(1):309-16. doi: 10.1016/j.jss.2011.07.045. Epub 2011 Aug 25.
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.
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.
Pratschke S, Arnold H, Zollner A, Heise M, Pascher A, Schemmer P, Scherer MN, Bauer A, Jauch KW, Werner J, Guba M, Angele MK. Results of the TOP Study: Prospectively Randomized Multicenter Trial of an Ex Vivo Tacrolimus Rinse Before Transplantation in EDC Livers. Transplant Direct. 2016 May 4;2(6):e76. doi: 10.1097/TXD.0000000000000588. eCollection 2016 Jun.
Pratschke S, Eder M, Heise M, Nadalin S, Pascher A, Schemmer P, Scherer MN, Ulrich F, Wolters H, Jauch KW, Wohling D, Angele MK. Protocol TOP-Study (tacrolimus organ perfusion): a prospective randomized multicenter trial to reduce ischemia reperfusion injury in transplantation of marginal liver grafts with an ex vivo tacrolimus perfusion. Transplant Res. 2013 Mar 4;2(1):3. doi: 10.1186/2047-1440-2-3.
Other Identifiers
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TOP-Study
Identifier Type: -
Identifier Source: org_study_id
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