Clinical trial NCT00737880: Histidine-Tryptophane-Ketoglutarate (HTK) vs University of Wisconsin (UW) Perfusion in Clinical Pancreas Transplantation
Official title: A Prospective Randomized Multicenter Trial Comparing Histidine-Tryptophane-Ketoglutarate (HTK) Versus University of Wisconsin (UW) Perfusion Solution in Clinical Pancreas Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
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
Lead sponsor: Medical University Innsbruck
Sponsor class: OTHER
Collaborators: name: University Hospital, Ghent
name: University of Rostock
name: Charite University, Berlin, Germany
name: Dr. F. Köhler Chemie GmbH
First posted: 2008-08-20
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Pancreas graft survival
timeFrame: 6 months after transplantation
Secondary outcomes:
measure: Serum amylase
timeFrame: 6 months after transplantation
measure: Serum lipase
timeFrame: 6 months after transplantation
measure: C-peptide
timeFrame: 6 months after transplantation
measure: HbA1c
timeFrame: 6 months after transplantation
measure: Exogenous insulin requirement
timeFrame: 6 months after transplantation
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Center of Operative Medicine / Department of Visceral, Transplant and Thoracic Surgery / Medical University Innsbruck
state: Tyrol
city: Gent
country: Belgium
facility: Department of General, Hepato-Biliary and Transplantation Surgery
city: Berlin
country: Germany
facility: Department of General, Visceral and Transplantation Surgery, Charite Campus Virchow Klinikum, Humboldt University Berlin
city: Rostock
country: Germany
facility: Department of General, Vascular, Thoracic and Transplantation Surgery, University of Rostock
Study officials:
affiliation: Transplantat Surgery, Medical University Innsbruck
name: Alfred Königsrainer, Prof., M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schneeberger S, Biebl M, Steurer W, Hesse UJ, Troisi R, Langrehr JM, Schareck W, Mark W, Margreiter R, Konigsrainer A. A prospective randomized multicenter trial comparing histidine-tryptophane-ketoglutarate versus University of Wisconsin perfusion solution in clinical pancreas transplantation. Transpl Int. 2009 Feb;22(2):217-24. doi: 10.1111/j.1432-2277.2008.00773.x. Epub 2008 Oct 24.