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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00737880

Enrollment

Registered

2008-08-20

Start date

2001-07-31

Completion date

2005-12-31

Last updated

2008-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Pancreas Transplantation

Keywords

Pancreas Clinical, Donor, Pancreas Clinical, Preservation Solutions, Organ Preservation and Procurement, Surgery, Organ Procurement, Ischemia reperfusion Injury, Organ Preservation and Procurement

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.

Interventions

OTHEROrgan perfusion during pancreas procurement

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

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

Design outcomes

Primary

Measure	Time frame
Pancreas graft survival	6 months after transplantation

Secondary

Measure	Time frame
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

Countries

Austria, Belgium, Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026