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

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00737880
• Other study ID #: CL-KSM-III/6/00
• Status: Completed
• Phase: Phase 4
• First received: August 19, 2008
• Last updated: August 19, 2008
• Start date: July 2001
• Est. completion date: December 2005

Study information

• Verified date: August 2008
• Source: Medical University Innsbruck
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Federal Ministry for Health Family and Youth
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: December 2005
• Est. primary completion date: January 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Pancreas Transplantation

Intervention

Other:
• Organ perfusion during pancreas procurement
Usage of UW or HTK perfusion solution during in situ abdominal organ perfusion in multi-organ procurement

Locations

Country	Name	City	State
Austria	Center of Operative Medicine / Department of Visceral, Transplant and Thoracic Surgery / Medical University Innsbruck	Innsbruck	Tyrol
Belgium	Department of General, Hepato-Biliary and Transplantation Surgery	Gent
Germany	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

Sponsors (5)

Lead Sponsor	Collaborator
Medical University Innsbruck	Charite University, Berlin, Germany, Dr. F. Köhler Chemie GmbH, University Hospital, Ghent, University of Rostock

Countries where clinical trial is conducted

Austria,  Belgium,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pancreas graft survival		6 months after transplantation	Yes
Secondary	Serum amylase		6 months after transplantation	No
Secondary	Serum lipase		6 months after transplantation	No
Secondary	C-peptide		6 months after transplantation	No
Secondary	HbA1c		6 months after transplantation	No
Secondary	Exogenous insulin requirement		6 months after transplantation	No