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| Name | Class |
|---|---|
| University Hospital, Ghent | OTHER |
| University of Rostock | OTHER |
| Charite University, Berlin, Germany | OTHER |
| Dr. F. Köhler Chemie GmbH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | In situ organ perfusion using HTK solution during pancreas procurement |
|
| 2 | Active Comparator | In situ perfusion using UW solution during pancreas procurement |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Organ perfusion during pancreas procurement | Other | Usage of UW or HTK perfusion solution during in situ abdominal organ perfusion in multi-organ procurement |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pancreas graft survival | 6 months after transplantation |
| Measure | Description | Time Frame |
|---|---|---|
| Serum amylase | 6 months after transplantation | |
| Serum lipase | 6 months after transplantation | |
| C-peptide |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alfred Königsrainer, Prof., M.D. | Transplantat Surgery, Medical University Innsbruck | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center of Operative Medicine / Department of Visceral, Transplant and Thoracic Surgery / Medical University Innsbruck | Innsbruck | Tyrol | 6020 | Austria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18954363 | Derived | 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. |
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| INDUSTRY |
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| 6 months after transplantation |
| HbA1c | 6 months after transplantation |
| Exogenous insulin requirement | 6 months after transplantation |
| Department of General, Hepato-Biliary and Transplantation Surgery | Ghent | 9000 | Belgium |
| Department of General, Visceral and Transplantation Surgery, Charite Campus Virchow Klinikum, Humboldt University Berlin | Berlin | State of Berlin | 13353 | Germany |
| Department of General, Vascular, Thoracic and Transplantation Surgery, University of Rostock | Rostock | 18057 | Germany |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D015427 | Reperfusion Injury |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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