Blood Group A2 Donor to Blood Group O Recipient Lung Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Incidence of malignancy
研究概览
简要总结
Blood group A2 to blood group O kidney and liver transplants have been shown to be safe and successful, especially in recipients with low pre-operative anti-A antibody titers and with the use of peri-operative antibody-depleting therapies. Since blood group O lung transplant candidates tend to have longer wait times and a higher waitlist mortality compared to other blood groups, we propose to conduct a prospective study of lung transplantation from blood group A2 donors to eligible blood group O recipients in an effort to increase the available donor pool. The aim of this study is to determine both the feasibility and safety of this specific type of ABO-incompatible lung transplant, and the impact of this practice on reducing transplant wait times among blood group O lung transplant candidates. This would represent the first prospective study of ABO-incompatible lung transplants worldwide.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •first lung transplant
- •blood group O recipient
- •low pre-operative anti-A antibody titers
- •consent to study participation
排除标准
- •re-transplant
- •multiorgan transplant
- •positive virtual crossmatch at time of transplant
结局指标
主要结局
Incidence of malignancy
时间窗: 10 years
C4d positivity on transbronchial biopsy samples
时间窗: 1 year
Graft function
时间窗: 10 years
Post-transplant anti-A antibody titers
时间窗: post-op day 5 or day 12
Primary graft dysfunction grade
时间窗: post-op day 0, 1, 2, 3
Incidence of hyperacute antibody-mediated rejection
时间窗: post-op day 1, 2
Incidence and severity of acute cellular rejection
时间窗: 1 year
Chronic lung allograft dysfunction
时间窗: 10 years
Time to death or re-transplantation
时间窗: 10 years
Bleeding
时间窗: post-op day 1-7
Infection
时间窗: 10 years
次要结局
未报告次要终点