Lung Transplant Infection, Lung Transplant Rejection
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEECP (Extracorporeal Photopheresis System)
Patients who are assigned to the ECP group receive treatments by means of the THERAKOS ® CELLEX ® Photopheresis System (Mallinckrodt Pharmaceuticals Inc.) with either double- or single-needle access. During the leukapheretic processing, 1500 ml of whole blood is processed, and peripheral blood mononuclear cells (MCNs) are separated by centrifugation and collected in the buffy coat. 8-methoxypsoralen (Uvadex®, Mallinckrodt Pharmaceuticals Inc.) at a dose of 20 μg/ml is added to the MNC collection bag and cells are irradiated with ultraviolet A light (1.5 J/cm2) in a 1-mm-thick film through a photoactivation plate. After exposure of the cells to the ultraviolet light, the buffy coat is reinfused into the patient.
Sponsors
Medical University of Vienna
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite endpoint | 24 months | the incidence of high-grade ACR, cytomegalovirus (CMV) infection or CLAD |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of clinically treated infections | 24 months | Incidence of clinically treated infections |
| Detection of plasma CMV DNA | 24 months | Detection of plasma CMV DNA |
| Patient survival | 36 months | Patient survival |
| Frequency of ACR and of lymphocytic bronchiolitis (LB) | 24 months | Frequency of ACR and of lymphocytic bronchiolitis (LB) |
| Incidence of de-novo donor specific antibodies | 24 months | Incidence of de-novo donor specific antibodies |
| Number of AMR episodes | 24 months | Number of AMR episodes |
| Incidence of CLAD | 36 months | Incidence of CLAD |
| Graft survival | 36 months | Graft survival |
Countries
Austria
Outcome results
None listed