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

NCT00737880 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2008-08-20

No results posted yet for this study

Summary

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.

Conditions

Interventions

OTHER

Organ perfusion during pancreas procurement

Usage of UW or HTK perfusion solution during in situ abdominal organ perfusion in multi-organ procurement

Sponsors & Collaborators

  • University Hospital, Ghent

    collaborator OTHER

  • University of Rostock

    collaborator OTHER

  • Charite University, Berlin, Germany

    collaborator OTHER

  • Dr. F. Köhler Chemie GmbH

    collaborator INDUSTRY

  • Medical University Innsbruck

    lead OTHER

Principal Investigators

  • Alfred Königsrainer, Prof., M.D. · Transplantat Surgery, Medical University Innsbruck

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-07-31
Primary Completion
2004-01-31
Completion
2005-12-31

Countries

  • Austria
  • Belgium
  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00737880 on ClinicalTrials.gov