Global Utilization And Registry Database for Improved preservAtion of doNor Pancreata (GUARDIAN-PANCREAS)
1 other identifier
observational
1,000
0 countries
N/A
Brief Summary
The primary objective of this study is to collect real-world clinical performance data to assess the clinical outcomes of patients receiving pancreas transplants using donor pancreata transported via the PancreasPak system. These results will be compared to standard of care outcomes, as well as other preservation methods.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2026
Longer than P75 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 17, 2026
CompletedFirst Posted
Study publicly available on registry
March 23, 2026
CompletedStudy Start
First participant enrolled
June 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2031
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2032
March 23, 2026
March 1, 2026
5 years
March 17, 2026
March 17, 2026
Conditions
Outcome Measures
Primary Outcomes (8)
Graft dysfunction
The percentage of subjects in each cohort who experience graft dysfunction post-transplant.
Post-transplant through 1 year post-transplant
Pancreatitis
The percentage of subjects in each cohort who experience pancreatitis post-transplant.
Post-transplant through 1 year post-transplant
Primary Non-Function
The percentage of subjects in each cohort who primary non-function post transplantation.
Post-transplant through 7 days post-transplant
Length of Hospital Stay
How many days the patients stays in the hospital post-transplant.
1 year
Surgical Complications
The percentage of subjects in each cohort who experience surgical complications.
Post-transplant through 1 year post-transplant
Insulin Dependence
The percentage of subjects in each cohort who experience insulin dependence post-transplant.
Post-transplant through 1 year post-transplant
Graft Failure
The percentage of subjects in each cohort who develop graft failure post-transplant.
Post-transplant through 1 year post
Survival
The percentage of subjects in each cohort who survive through 1 year post-transplant.
Post-transplant through 1 year post
Secondary Outcomes (4)
Length of ICU Stay
1 year
Interventions for Anastomotic Complications
Post-transplant through 1 year post-transplant
Intervention for Vascular Complications
Post-transplant through 1 year-post transplant
Medications
Post-transplant through 1 year post-transplant
Study Arms (2)
PancreasPak patient
Patients whose donor pancreas was transported with the PancreasPak device.
Standard method patients
Patients whose donor pancreas was transported with a method other than the PancreasPak device.
Interventions
The PancreasPak Donor Preservation System is a FDA cleared and CE-marked medical device intended to be used for the static hypothermic preservation of donor pancreata during transportation and eventual transplantation using cold preservation solutions indicated for use in donor pancreata transplantation. The intended organ preservation time for the PancreasPak system is up to 21 hours.
Eligibility Criteria
Patients who have received a pancreas transplant at centers that use the PancreasPak device.
You may qualify if:
- Adult or pediatric recipients of pancreas alone, simultaneous pancreas-kidney, or pancreas after kidney transplant
You may not qualify if:
- Donor pancreata that do not meet institutional clinical requirements for transplantation
- Simultaneous pancreas-kidney transplant recipients who received donor organs from multiple donors
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 17, 2026
First Posted
March 23, 2026
Study Start
June 1, 2026
Primary Completion (Estimated)
June 1, 2031
Study Completion (Estimated)
January 1, 2032
Last Updated
March 23, 2026
Record last verified: 2026-03