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

August 19, 2008 updated by: Medical University Innsbruck

A Prospective Randomized Multicenter Trial Comparing Histidine-Tryptophane-Ketoglutarate (HTK) Versus University of Wisconsin (UW) Perfusion Solution in Clinical Pancreas Transplantation

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

68

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
    • Tyrol
      • Innsbruck, Tyrol, Austria, 6020
        • Center of Operative Medicine / Department of Visceral, Transplant and Thoracic Surgery / Medical University Innsbruck
  • Belgium
      • Gent, Belgium, 9000
        • Department of General, Hepato-Biliary and Transplantation Surgery
  • Germany
      • Berlin, Germany, 13353
        • Department of General, Visceral and Transplantation Surgery, Charite Campus Virchow Klinikum, Humboldt University Berlin
      • Rostock, Germany, 18057
        • Department of General, Vascular, Thoracic and Transplantation Surgery, University of Rostock

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pancreas graft survival
Time Frame: 6 months after transplantation
6 months after transplantation

Secondary Outcome Measures

Outcome Measure
Time Frame
Serum amylase
Time Frame: 6 months after transplantation
6 months after transplantation
Serum lipase
Time Frame: 6 months after transplantation
6 months after transplantation
C-peptide
Time Frame: 6 months after transplantation
6 months after transplantation
HbA1c
Time Frame: 6 months after transplantation
6 months after transplantation
Exogenous insulin requirement
Time Frame: 6 months after transplantation
6 months after transplantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University Innsbruck

Collaborators

Charite University, Berlin, Germany
University Hospital, Ghent
University of Rostock
Dr. F. Köhler Chemie GmbH

Investigators

  • Principal Investigator: Alfred Königsrainer, Prof., M.D., Transplantat Surgery, Medical University Innsbruck

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2001

Primary Completion (Actual)

January 1, 2004

Study Completion (Actual)

December 1, 2005

Study Registration Dates

First Submitted

August 19, 2008

First Submitted That Met QC Criteria

August 19, 2008

First Posted (Estimate)

August 20, 2008

Study Record Updates

Last Update Posted (Estimate)

August 20, 2008

Last Update Submitted That Met QC Criteria

August 19, 2008

Last Verified

August 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CL-KSM-III/6/00

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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