Prophylactic Use of Extracorporeal Photopheresis (ECP) After Lung Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- Composite endpoint
研究概览
简要总结
The purpose of this study is to investigate the use of ECP for lung-transplanted patients to reduce the occurrence of acute and chronic rejection and CMV-infection.
详细描述
The intention of the planned study is the use of ECP as a form of induction treatment in combination with standard triple-drug immunosuppressive therapy (IS). This is a single-center prospective randomized controlled trial conducted at Medical University of Vienna between 2018 and 2020. It includes 31 COPD recipients per group. Treatment group underwent ECP with in addition to IS after lung transplantation. Control group received only IS. The primary outcome was a composite outcome defined as incidence of high-grade ACR, CMV infection or CLAD within 24 months after lung transplantation.
Parallel to the clinical parameters, immunologic investigations will be performed to get a better insight into the mechanisms of ECP on the immune system. The dynamics of Tregs and dentritic cell will be analyzed to compare the influence of ECP vs standard IS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Patients undergoing first lung transplantation
- •Patient underlying disease COPD
- •Male or female be 18 years or older
- •Patients (male and female) must agree to use an acceptable method of birth control the treatment period of 3 months and 3 months afterward
- •Patients must have a body weight more than 40 kg
- •Patients must have a platelet count more than 20.000/cmm
- •Patients must be willing and capable of understanding the purpose and risks of the study and must sign a statement of informed consent
排除标准
- •Previous organ transplantation
- •Women who are pregnant and/or lactating
- •Patients with hypersensitivity or allergy to both heparin and citrate products
- •Patients who are unable to tolerate extracorporeal volume shifts associated with ECP treatment due to the presence of any of the following conditions: uncompensated congestive heart failure, pulmonary edema, renal failure or hepatic failure
结局指标
主要结局
Composite endpoint
时间窗: 24 months
the incidence of high-grade ACR, cytomegalovirus (CMV) infection or CLAD
次要结局
- Patient survival(36 months)
- Incidence of de-novo donor specific antibodies(24 months)
- Detection of plasma CMV DNA(24 months)
- Graft survival(36 months)
- Number of AMR episodes(24 months)
- Frequency of ACR and of lymphocytic bronchiolitis (LB)(24 months)
- Incidence of clinically treated infections(24 months)
- Incidence of CLAD(36 months)
研究者
Peter Jaksch, Priv.Doz. Dr.
Priv.-Doz.Dr.
Medical University of Vienna