Global Utilization and Registry Database for Improved Preservation of Donor Lungs
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 3,500
- 试验地点
- 30
- 主要终点
- Number of subjects with rejection
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 lung that were preserved and transported within the LUNGguard system, as well as retrospective standard of care patients
详细描述
GUARDIAN-Lung is a post-market, observational registry of adult and pediatric lung transplant recipient patients whose donor lungs was preserved and transported within the LUNGguard. 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 3,500 male and female subjects (including pediatric patients) meeting the study inclusion and exclusion criteria will be enrolled into the study at about 25 clinical sites.
Candidates that fit the eligibility criteria and have had their donor lungs 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 lungs matched to the prospective recipient based upon institutional medical practice
- •Registered male or female primary lung transplant candidates including pediatric candidates
排除标准
- •Donor and donor lungs that do not meet institutional clinical requirements for transplantation
- •Patients who are incarcerated persons (prisoners)
- •Patients who have had a previous major organ transplant (heart, lungs, liver, kidney, pancreas)
- •Patients who are receiving multiple organ transplants
研究组 & 干预措施
LungGuard patients
Patients whose donor lung(s) was transported with the LungGuard device.
干预措施: LungGuard (Device)
Standard Transport Patients
Patients whose donor lung(s) was transported with a method other than the LungGuard
BAROGuard Patients
Patients whose donor lung(s) was transported with the BAROGuard device.
干预措施: BAROGuard (Device)
结局指标
主要结局
Number of subjects with rejection
时间窗: Post-transplant through 1 year post
Subjects that show signs to rejection after transplant
Number of subjects with Primary Graft Dysfunction (PGD)
时间窗: Post-transplant through 1 year post
The number of subjects that develop PGD after transplant
Survival
时间窗: Post-transplant through 1 year post
patient survival post-transplant
Hospital Length of Stay
时间窗: Transplant through 1 year post-transplant
Days the subject was in the hospital in total after transplant
ICU Length of Stay
时间窗: Transplant through 1 year post-transplant
Days the subject spent the ICU post-transplant
Number of subjects with Primary Graft Dysfunction (PGD)
时间窗: Post-transplant through 5 years post
The number of subjects that develop PGD after transplant
Number of subjects with rejection
时间窗: Post-transplant through 5 years post
Subjects that show signs to rejection after transplant
Survival
时间窗: Post-transplant through 5 years post
patient survival post-transplant
ICU Length of Stay
时间窗: Transplant through 5 years post-transplant
Days the subject spent the ICU post-transplant
Hospital Length of Stay
时间窗: Transplant through 5 years post-transplant
Days the subject was in the hospital in total after transplant
次要结局
- How long subjects needed mechanical support(pre-transplant through 48 hours post-transplant)
- Number of rehospitalizations(post-transplant through 1 year)