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

Medical University Innsbruck

Status and phase: Completed; Phase 4

Conditions: Pancreas Transplantation; Diabetes Mellitus

Treatments: Other: Organ perfusion during pancreas procurement

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00737880

CL-KSM-III/6/00

Details and patient eligibility

About

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.

Enrollment: 68 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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68 participants in 2 patient groups

1

Active Comparator group

Description:

In situ organ perfusion using HTK solution during pancreas procurement

Treatment:

Other: Organ perfusion during pancreas procurement

2

Active Comparator group

Description:

In situ perfusion using UW solution during pancreas procurement

Treatment:

Other: Organ perfusion during pancreas procurement