Global Utilization and Registry Database for Improved Preservation of Donor Livers
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 2,000
- 试验地点
- 22
- 主要终点
- Early allograft dysfunction
研究概览
简要总结
The objective of this registry is to collect and evaluate various clinical effectiveness parameters in patients with transplanted donor liver that were preserved and transported within the LIVERguard system, as well as retrospective standard of care patients
详细描述
GUARDIAN-Liver is a post-market, observational registry of adult and pediatric liver transplant recipient patients whose donor liver was preserved and transported within the LIVERguard. 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 2,000 male and female subjects meeting the study inclusion and exclusion criteria will be enrolled into the study at about 20 clinical sites.
Candidates that fit the eligibility criteria and have had their donor liver 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
- Cross Sectional
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Donor and donor liver matched to the recipient based upon institutional medical practice
- •Registered male or female liver transplant candidates
排除标准
- •Donor and donor liver that do not meet institutional clinical requirements for transplantation
- •Living donors
研究组 & 干预措施
LIVERguard patient
Patients whose donor liver was transported with the LiverGuard device.
干预措施: LIVERguard (Device)
Standard Transport Patients
Patients whose donor liver was transported with a method other than the LiverGuard
结局指标
主要结局
Early allograft dysfunction
时间窗: 7 days post transplant
The percentage of subjects in each cohort who early allograft failure post-transplant
Survival
时间窗: Transplant through 1 year post-transplant
The percentage of subjects in each cohort who survive through 1 year post-transplant
Length of ICU stay
时间窗: 1 year
How many days the patient stayed in the ICU post-transplant
Length of Stay
时间窗: 1 year
How many days the patient stays in the hospital post-transplant
Rejection
时间窗: Post-transplant through 1 year post
The percentage of subjects in each cohort who experience rejection post-transplant
Primary Non-function
时间窗: Post transplant to 7 days post-transplant
The percentage of subjects in each cohort who experience primary non-function 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
次要结局
- Hospitalizations(post-transplant through 1 year)
- Biliary complications(post-transplant through 1 year post-transplant)