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Not yet recruiting NCT07487194

Global Utilization And Registry Database for Improved preservAtion of doNor Pancreata (GUARDIAN-PANCREAS)

— Observational Pancreas (Including SPK) Transplantation Pancreas Diseases Pancreas Transplant Rejection Pancreas Transplant; Complications

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: PancreasPak.
Who it may be relevant to
Registry conditions: Pancreas (Including SPK) Transplantation, Pancreas Diseases, Pancreas Transplant Rejection, Pancreas Transplant; Complications. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Detailed description

GUARDIAN-PANCREAS is a post-market, observational registry of adult transplant recipient patients whose donor pancreas was preserved and transported within the PancreasPak. The data is being collected retrospectively from medical records of patients already transplanted before the initiation of the registry and any new patients who meet the eligibility criteria.

About 1000 subjects meeting the study inclusion and exclusion criteria will be enrolled into the study at about 15 clinical sites.

Candidates that fit the eligibility criteria and have had their donor pancreas transported with a Paragonix product or a standard of care method can be enrolled. The baseline characteristics and outcomes of the two groups will be compared.

Interventions

  • Device PancreasPak
    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.

Primary outcome measures

  • Graft dysfunction [Time frame: Post-transplant through 1 year post-transplant]
  • Pancreatitis [Time frame: Post-transplant through 1 year post-transplant]
  • Primary Non-Function [Time frame: Post-transplant through 7 days post-transplant]
  • Length of Hospital Stay [Time frame: 1 year]
  • Surgical Complications [Time frame: Post-transplant through 1 year post-transplant]
  • Insulin Dependence [Time frame: Post-transplant through 1 year post-transplant]
  • Graft Failure [Time frame: Post-transplant through 1 year post]
  • Survival [Time frame: Post-transplant through 1 year post]
Secondary outcome measures (4)
  • Length of ICU Stay [Time frame: 1 year]
  • Interventions for Anastomotic Complications [Time frame: Post-transplant through 1 year post-transplant]
  • Intervention for Vascular Complications [Time frame: Post-transplant through 1 year-post transplant]
  • Medications [Time frame: Post-transplant through 1 year post-transplant]

Eligibility criteria

Inclusion criteria

  • Adult or pediatric recipients of pancreas alone, simultaneous pancreas-kidney, or pancreas after kidney transplant

Exclusion criteria

  • Donor pancreata that do not meet institutional clinical requirements for transplantation
  • Simultaneous pancreas-kidney transplant recipients who received donor organs from multiple donors

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07487194 · PGX-008

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗