Pancreas Diseases, Pancreas (Including SPK) Transplantation, Pancreas Transplant; Complications, Pancreas Transplant Rejection
Conditions
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.
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
DEVICEPancreasPak
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.
Sponsors
Paragonix Technologies
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Graft dysfunction | Post-transplant through 1 year post-transplant | The percentage of subjects in each cohort who experience graft dysfunction post-transplant. |
| Pancreatitis | Post-transplant through 1 year post-transplant | The percentage of subjects in each cohort who experience pancreatitis post-transplant. |
| Primary Non-Function | Post-transplant through 7 days post-transplant | The percentage of subjects in each cohort who primary non-function post transplantation. |
| Length of Hospital Stay | 1 year | How many days the patients stays in the hospital post-transplant. |
| Surgical Complications | Post-transplant through 1 year post-transplant | The percentage of subjects in each cohort who experience surgical complications. |
| Insulin Dependence | Post-transplant through 1 year post-transplant | The percentage of subjects in each cohort who experience insulin dependence post-transplant. |
| Graft Failure | Post-transplant through 1 year post | The percentage of subjects in each cohort who develop graft failure post-transplant. |
| Survival | Post-transplant through 1 year post | The percentage of subjects in each cohort who survive through 1 year post-transplant. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of ICU Stay | 1 year | How many days the patient stayed in the ICU post-transplant. |
| Interventions for Anastomotic Complications | Post-transplant through 1 year post-transplant | The percentage of subjects in each cohort who required interventions due to anastomotic complications. |
| Intervention for Vascular Complications | Post-transplant through 1 year-post transplant | The percentage of subjects in each cohort who required interventions due to vascular complications. |
| Medications | Post-transplant through 1 year post-transplant | The percentage of subjects in each cohort who required the use of various medications. |
Contacts
CONTACTAmanda Schreiner
CONTACTJulia Hersum
Outcome results
None listed