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

Phase 4

Completed

• Conditions: Diabetes Mellitus; Pancreas Transplantation

• Registration Number: NCT00737880
• Lead Sponsor: Medical University Innsbruck

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-07
• Primary Completion: 2004-01
• Study Completion: 2005-12
• Status Verified: 2008-08
• Study First Submitted: 2008-08-19
• Study First Submitted QC: 2008-08-19
• Last Update Submitted: 2008-08-19
• Study First Posted: 2008-08-20
• Last Update Posted: 2008-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pancreas graft survival	6 months after transplantation

Secondary Outcome Measures

Name	Time	Method
Serum amylase	6 months after transplantation
Serum lipase	6 months after transplantation
C-peptide	6 months after transplantation
HbA1c	6 months after transplantation
Exogenous insulin requirement	6 months after transplantation

Trial Locations

Locations (4)

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; 🇧🇪 Gent, Belgium

Department of General, Visceral and Transplantation Surgery, Charite Campus Virchow Klinikum, Humboldt University Berlin; 🇩🇪 Berlin, Germany

Department of General, Vascular, Thoracic and Transplantation Surgery, University of Rostock; 🇩🇪 Rostock, Germany