Histidine-Tryptophane-Ketoglutarate (HTK) vs University of Wisconsin (UW) Perfusion in Clinical Pancreas Transplantation
NCT ID: NCT00737880
Last Updated: 2008-08-20
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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
68 participants
INTERVENTIONAL
2001-07-31
2005-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
For pancreas transplantation, University of Wisconsin (UW) solution is the most commonly used perfusate. However, over the last years, Histidine-Tryptophan-Ketoglutarate (HTK) solution has been increasingly used for abdominal organ procurement. Retrospective reports published so far have demonstrated the safety of both perfusion solutions.
However, to date, no prospective study comparing both perfusion solutions has been published. Aim of this study was to prospectively evaluate early pancreas graft function in clinical pancreas transplantation after organ perfusion with HTK vs. UW solution.
The study hypothesis is that HTK is not inferior to UW for organ perfusion during procurement in clinical pancreas transplantation.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
In situ organ perfusion using HTK solution during pancreas procurement
Organ perfusion during pancreas procurement
Usage of UW or HTK perfusion solution during in situ abdominal organ perfusion in multi-organ procurement
2
In situ perfusion using UW solution during pancreas procurement
Organ perfusion during pancreas procurement
Usage of UW or HTK perfusion solution during in situ abdominal organ perfusion in multi-organ procurement
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Organ perfusion during pancreas procurement
Usage of UW or HTK perfusion solution during in situ abdominal organ perfusion in multi-organ procurement
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* donor age 10 - 50 years
* donor body mass index \< 30kg/m2
* pancreas cold ischemia time \< 20 hours
* written informed consent of the pancreas recipient
Exclusion Criteria
* pancreas retransplantation
* recipient participation in another study
18 Years
60 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University Hospital, Ghent
OTHER
University of Rostock
OTHER
Charite University, Berlin, Germany
OTHER
Dr. F. Köhler Chemie GmbH
INDUSTRY
Medical University Innsbruck
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Transplantation Surgery / Medical University Innsbruck
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Alfred Königsrainer, Prof., M.D.
Role: PRINCIPAL_INVESTIGATOR
Transplantat Surgery, Medical University Innsbruck
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Center of Operative Medicine / Department of Visceral, Transplant and Thoracic Surgery / Medical University Innsbruck
Innsbruck, Tyrol, Austria
Department of General, Hepato-Biliary and Transplantation Surgery
Ghent, , Belgium
Department of General, Visceral and Transplantation Surgery, Charite Campus Virchow Klinikum, Humboldt University Berlin
Berlin, State of Berlin, Germany
Department of General, Vascular, Thoracic and Transplantation Surgery, University of Rostock
Rostock, , Germany
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Schneeberger S, Biebl M, Steurer W, Hesse UJ, Troisi R, Langrehr JM, Schareck W, Mark W, Margreiter R, Konigsrainer A. A prospective randomized multicenter trial comparing histidine-tryptophane-ketoglutarate versus University of Wisconsin perfusion solution in clinical pancreas transplantation. Transpl Int. 2009 Feb;22(2):217-24. doi: 10.1111/j.1432-2277.2008.00773.x. Epub 2008 Oct 24.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CL-KSM-III/6/00
Identifier Type: -
Identifier Source: org_study_id