NCT00737880

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P25-P50 for phase_4 diabetes-mellitus

Timeline
Completed

Started Jul 2001

Longer than P75 for phase_4 diabetes-mellitus

Geographic Reach
3 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2001

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2004

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

August 19, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 20, 2008

Completed
Last Updated

August 20, 2008

Status Verified

August 1, 2008

Enrollment Period

2.5 years

First QC Date

August 19, 2008

Last Update Submit

August 19, 2008

Conditions

Diabetes MellitusPancreas Transplantation

Keywords

Pancreas Clinical, DonorPancreas Clinical, Preservation SolutionsOrgan Preservation and Procurement, SurgeryOrgan Procurement, Ischemia reperfusion InjuryOrgan Preservation and Procurement

Outcome Measures

Primary Outcomes (1)

  • Pancreas graft survival

    6 months after transplantation

Secondary Outcomes (5)

  • 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

Study Arms (2)

1

ACTIVE COMPARATOR

In situ organ perfusion using HTK solution during pancreas procurement

Other: Organ perfusion during pancreas procurement

2

ACTIVE COMPARATOR

In situ perfusion using UW solution during pancreas procurement

Other: Organ perfusion during pancreas procurement

Interventions

Organ perfusion during pancreas procurementOTHER

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

12

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • missing written consent
  • pancreas retransplantation
  • recipient participation in another study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Center of Operative Medicine / Department of Visceral, Transplant and Thoracic Surgery / Medical University Innsbruck

Innsbruck, Tyrol, 6020, Austria

Location

Department of General, Hepato-Biliary and Transplantation Surgery

Ghent, 9000, Belgium

Location

Department of General, Visceral and Transplantation Surgery, Charite Campus Virchow Klinikum, Humboldt University Berlin

Berlin, State of Berlin, 13353, Germany

Location

Department of General, Vascular, Thoracic and Transplantation Surgery, University of Rostock

Rostock, 18057, Germany

Location

Related Publications (1)

  • 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.

    PMID: 18954363DERIVED

MeSH Terms

Conditions

Diabetes MellitusReperfusion Injury

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesVascular DiseasesCardiovascular DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Alfred Königsrainer, Prof., M.D.

    Transplantat Surgery, Medical University Innsbruck

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 19, 2008

First Posted

August 20, 2008

Study Start

July 1, 2001

Primary Completion

January 1, 2004

Study Completion

December 1, 2005

Last Updated

August 20, 2008

Record last verified: 2008-08

Locations

BE(1)AU(1)DE(2)