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NCT Number: NCT00737880

Histidine-Tryptophane-Ketoglutarate (HTK) vs University of Wisconsin (UW) Perfusion 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.

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Key information

Conditions

Diabetes Mellitus Cardiovascular Diseases Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Pancreas Transplantation Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Reperfusion Injury Vascular Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Center of Operative Medicine / Department of Visceral, Transplant and Thoracic Surgery / Medical University Innsbruck, Innsbruck, Tyrol, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Organ perfusion during pancreas procurement

Other

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

Primary outcomes

  1. Pancreas graft survival

    Time frame: 6 months after transplantation

Secondary outcomes

  1. Serum amylase

    Time frame: 6 months after transplantation

  2. Serum lipase

    Time frame: 6 months after transplantation

  3. C-peptide

    Time frame: 6 months after transplantation

  4. HbA1c

    Time frame: 6 months after transplantation

  5. Exogenous insulin requirement

    Time frame: 6 months after transplantation

Sponsors and collaborators

Lead sponsor

Medical University Innsbruck

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2001
Primary completion
2004
Study completion
2005
First posted
Aug 20, 2008
Registry last updated
Aug 20, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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