Histidine-Tryptophane-Ketoglutarate (HTK) vs University of Wisconsin (UW) Perfusion in Clinical Pancreas Transplantation

This study has been completed.
Sponsor:
Collaborators:
University Hospital, Ghent
University of Rostock
Charite University, Berlin, Germany
Dr. F. Köhler Chemie GmbH
Information provided by:
Medical University Innsbruck
ClinicalTrials.gov Identifier:
NCT00737880
First received: August 19, 2008
Last updated: NA
Last verified: August 2008
History: No changes posted
  Purpose

Graft preservation in clinical pancreas transplantation is based on hypothermia achieved by topic cooling and cold in situ flushing using special perfusion solutions designed to attenuate the effects of ischemia/reperfusion and prolong cold ischemia tolerance.

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.


Condition Intervention Phase
Diabetes Mellitus
Pancreas Transplantation
Other: Organ perfusion during pancreas procurement
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective Randomized Multicenter Trial Comparing Histidine-Tryptophane-Ketoglutarate (HTK) Versus University of Wisconsin (UW) Perfusion Solution in Clinical Pancreas Transplantation

Resource links provided by NLM:


Further study details as provided by Medical University Innsbruck:

Primary Outcome Measures:
  • Pancreas graft survival [ Time Frame: 6 months after transplantation ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Serum amylase [ Time Frame: 6 months after transplantation ] [ Designated as safety issue: No ]
  • Serum lipase [ Time Frame: 6 months after transplantation ] [ Designated as safety issue: No ]
  • C-peptide [ Time Frame: 6 months after transplantation ] [ Designated as safety issue: No ]
  • HbA1c [ Time Frame: 6 months after transplantation ] [ Designated as safety issue: No ]
  • Exogenous insulin requirement [ Time Frame: 6 months after transplantation ] [ Designated as safety issue: No ]

Enrollment: 68
Study Start Date: July 2001
Study Completion Date: December 2005
Primary Completion Date: January 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
In situ organ perfusion using HTK solution during pancreas procurement
Other: Organ perfusion during pancreas procurement
Usage of UW or HTK perfusion solution during in situ abdominal organ perfusion in multi-organ procurement
Active Comparator: 2
In situ perfusion using UW solution during pancreas procurement
Other: Organ perfusion during pancreas procurement
Usage of UW or HTK perfusion solution during in situ abdominal organ perfusion in multi-organ procurement

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • brain dead, heart beating organ donor
  • 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:

  • missing written consent
  • pancreas retransplantation
  • recipient participation in another study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00737880

Locations
Austria
Center of Operative Medicine / Department of Visceral, Transplant and Thoracic Surgery / Medical University Innsbruck
Innsbruck, Tyrol, Austria, 6020
Belgium
Department of General, Hepato-Biliary and Transplantation Surgery
Gent, Belgium, 9000
Germany
Department of General, Visceral and Transplantation Surgery, Charite Campus Virchow Klinikum, Humboldt University Berlin
Berlin, Germany, 13353
Department of General, Vascular, Thoracic and Transplantation Surgery, University of Rostock
Rostock, Germany, 18057
Sponsors and Collaborators
Medical University Innsbruck
University Hospital, Ghent
University of Rostock
Charite University, Berlin, Germany
Dr. F. Köhler Chemie GmbH
Investigators
Principal Investigator: Alfred Königsrainer, Prof., M.D. Transplantat Surgery, Medical University Innsbruck
  More Information

No publications provided by Medical University Innsbruck

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof. Dr. Alfred Königsrainer, Transplantation Surgery / Medical University Innsbruck
ClinicalTrials.gov Identifier: NCT00737880     History of Changes
Other Study ID Numbers: CL-KSM-III/6/00
Study First Received: August 19, 2008
Last Updated: August 19, 2008
Health Authority: Austria: Federal Ministry for Health Family and Youth

Keywords provided by Medical University Innsbruck:
Pancreas Clinical, Donor
Pancreas Clinical, Preservation Solutions
Organ Preservation and Procurement, Surgery
Organ Procurement, Ischemia reperfusion Injury
Organ Preservation and Procurement

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pancreatin
Pancrelipase
Pharmaceutical Solutions
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014