Ignite Creation Date:
2024-05-06 @ 6:36 PM
Last Modification Date:
2024-10-26 @ 2:51 PM
Study NCT ID:
NCT05721079
Status:
COMPLETED
Last Update Posted:
2023-02-09
First Post:
2023-01-31
Brief Title:
Extracorporeal Photopheresis ECP After Lung Transplantation
Sponsor:
Medical University of Vienna
Organization:
Medical University of Vienna
Study Overview
Official Title:
Prophylactic Use of Extracorporeal Photopheresis ECP After Lung Transplantation
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None