TxAccess and Dd-cfDNA for Improved Care of Patients With Delayed Graft Function
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 450
- 主要终点
- Delayed Graft Function (DGF) severity, defined as time to freedom from dialysis
研究概览
简要总结
This is a prospective multicenter nonrandomized pragmatic hybrid effectiveness-implementation study to test the effectiveness of TxAccess in improving time to renal recovery and immunologic outcomes in patients with delayed graft function (DGF) and to assess barriers and facilitators to implementation of TxAccess in the post-transplant care period. Research blood will be collected for donor-derived cell-free DNA testing, and patient questionnaires will be administered.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Study Population: Patients Inclusion criteria: Adult patients who experienced delayed graft function after a deceased donor kidney transplant in the last 2 calendar years
排除标准
- •Patients younger than 18 years old at the time of transplant; patients who experienced graft loss prior to discharge from their index hospitalization patients who receive outpatient dialysis at a center that does not utilize TxAccess (intervention period)
- •Study Population: Clinicians Inclusion criteria: adult clinicians who participate in care of kidney transplant recipients, including surgeons, nephrologists, pharmacists, social workers, nurse coordinators, advanced practice providers, nurses, case managers and dialysis center clinicians and staff.
- •Exclusion criteria: clinicians and staff who are not employed at participating centers or do not have direct patient contact or experience with care coordination
研究组 & 干预措施
TxAccess Intervention Arm
Participants receive standard post-transplant care with deployment of the TxAccess platform and dd-cfDNA monitoring.
干预措施: TxAccess (Device)
TxAccess Intervention Arm
Participants receive standard post-transplant care with deployment of the TxAccess platform and dd-cfDNA monitoring.
干预措施: Donor-Derived Cell-Free DNA (dd-cfDNA) (Diagnostic Test)
结局指标
主要结局
Delayed Graft Function (DGF) severity, defined as time to freedom from dialysis
时间窗: through 90 days post-transplant
次要结局
- Allograft biopsy rate(first post transplant year)
- Health Care Resource Utilization (hospital length of stay)(first post transplant year)
- Health Care Resource Utilization (readmission rate)(first post transplant year)
- Health Care Resource Utilization (days in intensive care unit)(first post transplant year)
- Dialysis utilization(90 days after transplant procedure)
- Health care related quality of life(90 days after transplant procedure)