A Prospective Randomized Multicenter Trial Comparing Histidine-Tryptophane-Ketoglutarate (HTK) Versus University of Wisconsin (UW) Perfusion Solution in Clinical Pancreas Transplantation
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 68
- Locations
- 8
- Primary Endpoint
- Pancreas graft survival
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Pancreas graft survival
Time Frame: 6 months after transplantation
Secondary Outcomes
- 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)