Diabetes MellitusPhase 4NCT00737880
Histidine-Tryptophane-Ketoglutarate (HTK) vs University of Wisconsin (UW) Perfusion in Clinical Pancreas Transplantation
A Phase 4 study testing Organ perfusion during pancreas procurement in people with Diabetes Mellitus and Pancreas Transplantation, run by Medical University Innsbruck at 4 sites in 3 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Diabetes Mellitus, Pancreas Transplantation
- What is being tested?
- Organ perfusion during pancreas procurement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 4 sitesin 3 countries
- Study dates
- Jul 2001to Dec 2005
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- missing written consent
- pancreas retransplantation
- recipient participation in another study
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
Germany2 sites
Department of General, Visceral and Transplantation Surgery, Charite Campus Virchow Klinikum, Humboldt University Berlin
Berlin, State of Berlin, 13353
Department of General, Vascular, Thoracic and Transplantation Surgery, University of Rostock
Rostock, 18057
Austria1 site
Center of Operative Medicine / Department of Visceral, Transplant and Thoracic Surgery / Medical University Innsbruck
Innsbruck, Tyrol, 6020
Belgium1 site
Department of General, Hepato-Biliary and Transplantation Surgery
Ghent, 9000
About this study
Official title: A Prospective Randomized Multicenter Trial Comparing Histidine-Tryptophane-Ketoglutarate (HTK) Versus University of Wisconsin (UW) Perfusion Solution in Clinical Pancreas Transplantation
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.
Read more
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.
- Conditions
- Diabetes Mellitus, Pancreas Transplantation
- Being tested
- Organ perfusion during pancreas procurement
- Keywords
- Pancreas Clinical, Donor, Pancreas Clinical, Preservation Solutions, Organ Preservation and Procurement, Surgery, Organ Procurement, Ischemia reperfusion Injury, Organ Preservation and Procurement
- Medical subject headings
- Diabetes Mellitus, Reperfusion Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Organ perfusion during pancreas procurementOther
Usage of UW or HTK perfusion solution during in situ abdominal organ perfusion in multi-organ procurement
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | In situ organ perfusion using HTK solution during pancreas procurement Receives: Other: Organ perfusion during pancreas procurement |
| 2 | Active comparator | In situ perfusion using UW solution during pancreas procurement Receives: Other: Organ perfusion during pancreas procurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pancreas graft survival
Measured: 6 months after transplantation
Secondary outcomes (5)
Serum amylase
Measured: 6 months after transplantation
Serum lipase
Measured: 6 months after transplantation
C-peptide
Measured: 6 months after transplantation
HbA1c
Measured: 6 months after transplantation
Exogenous insulin requirement
Measured: 6 months after transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2008 (estimated)
- Study startJul 2001
- Primary completionJan 2004
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Medical University InnsbruckThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University Innsbruck
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Ghent, University of Rostock, Charite University, Berlin, Germany, Dr. F. Köhler Chemie GmbH
- Investigators
- Alfred Königsrainer, Prof., M.D., Principal investigator, Transplantat Surgery, Medical University Innsbruck
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00737880
- Sponsor's protocol ID
- CL-KSM-III/6/00
- Status last verified
- Aug 2008
- First submitted
- 19 Aug 2008
- Last updated
- 20 Aug 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 18954363
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Multicenter Trial Comparing Histidine-Tryptophane-Ketoglutarate (HTK) Versus University of Wisconsin (UW) Perfusion Solution in Clinical Pancreas Transplantation
- ClinicalTrials.gov ID
- NCT00737880
- Acronym / sponsor ID
- CL-KSM-III/6/00
- 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
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Medical University InnsbruckUniversity, hospital or other
- Collaborators
- University Hospital, Ghent, University of Rostock, Charite University, Berlin, Germany, Dr. F. Köhler Chemie GmbH
- Study start
- Jul 2001
- Primary completion
- Jan 2004 (actual)
- Study completion
- Dec 2005 (actual)
- First posted
- 20 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Other: Organ perfusion during pancreas procurementIn situ organ perfusion using HTK solution during pancreas procurement |
| 2 | Active comparator | Other: Organ perfusion during pancreas procurementIn situ perfusion using UW solution during pancreas procurement |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- missing written consent
- pancreas retransplantation
- recipient participation in another study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Organ perfusion during pancreas procurementUsage of UW or HTK perfusion solution during in situ abdominal organ perfusion in multi-organ procurement | Other | 1, 2 |
Primary outcome
Pancreas graft survival
Time frame: 6 months after transplantation
5 secondary outcomes
Serum amylase
Time frame: 6 months after transplantation
Serum lipase
Time frame: 6 months after transplantation
C-peptide
Time frame: 6 months after transplantation
HbA1c
Time frame: 6 months after transplantation
Exogenous insulin requirement
Time frame: 6 months after transplantation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2008.
- Derived from this study: PubMed 18954363Schneeberger 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alfred Königsrainer, Prof., M.D. principal investigator
Transplantat Surgery, Medical University Innsbruck
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Organ perfusion during pancreas procurement in people with Diabetes Mellitus and Pancreas Transplantation, run by Medical University Innsbruck at 4 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Germany, Austria, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pancreas graft survival (time frame: 6 months after transplantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00737880, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2008; AzTrials last refreshed its copy on 8 Nov 2026.