Global Utilization And Registry Database for Improved preservAtion of doNor Pancreata (GUARDIAN-PANCREAS)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,000
- 主要终点
- Primary Non-Function
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult or pediatric recipients of pancreas alone, simultaneous pancreas-kidney, or pancreas after kidney transplant
排除标准
- •Donor pancreata that do not meet institutional clinical requirements for transplantation
- •Simultaneous pancreas-kidney transplant recipients who received donor organs from multiple donors
结局指标
主要结局
Primary Non-Function
时间窗: Post-transplant through 7 days post-transplant
The percentage of subjects in each cohort who primary non-function post transplantation.
Graft dysfunction
时间窗: Post-transplant through 1 year post-transplant
The percentage of subjects in each cohort who experience graft dysfunction post-transplant.
Pancreatitis
时间窗: Post-transplant through 1 year post-transplant
The percentage of subjects in each cohort who experience pancreatitis post-transplant.
Length of Hospital Stay
时间窗: 1 year
How many days the patients stays in the hospital post-transplant.
Surgical Complications
时间窗: Post-transplant through 1 year post-transplant
The percentage of subjects in each cohort who experience surgical complications.
Insulin Dependence
时间窗: Post-transplant through 1 year post-transplant
The percentage of subjects in each cohort who experience insulin dependence post-transplant.
Graft Failure
时间窗: Post-transplant through 1 year post
The percentage of subjects in each cohort who develop graft failure post-transplant.
Survival
时间窗: Post-transplant through 1 year post
The percentage of subjects in each cohort who survive through 1 year post-transplant.
次要结局
- 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)