NCT03798860已完成不适用
Monitoring of Donor-specific Antibodies (DSA) After Combined Treatment With Immunoglobulin A and Immunoglobulin M-enriched Intravenous Human Immunoglobulins and Plasmapheresis and Rituximab in Lung Transplantation
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 340
- 试验地点
- 1
- 主要终点
- Donor-specific Antibodies Clearance
研究概览
简要总结
Single-arm, prospective observational study
详细描述
This is an observational study to monitor the treatment of donor-specific antibodies in lung transplant recipients with detection of donor-specific antibodies. All consented subjects will be approached for participation. The study will evaluate the effectiveness of the treatment protocol of donor-specific antibodies with Immunoglobulins or combined treatment with Immunoglobulins, Plasmapheresis and Rituximab after lung transplantation.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •all patients after lung transplantation with detection of donor-specific antibodies
排除标准
- 未提供
结局指标
主要结局
Donor-specific Antibodies Clearance
时间窗: 6, 12, 18, 24 months
The DSA clearance is defined as absence of DSA in the Luminex test, which is performed every 6 months after treatment end.
次要结局
- Graft survival(1, 3, 5 years)
- Incidence of acute cellular and humoral rejections and chronic lung allograft dysfunction (CLAD)(1, 3, 5 years)
研究者
研究点 (1)
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