Extracorporeal Photopheresis (ECP) After Lung Transplantation

Not Applicable

Completed

• Conditions: Lung Transplant Infection; Lung Transplant Rejection
• Interventions: Device: ECP (Extracorporeal Photopheresis System)

• Registration Number: NCT05721079
• Lead Sponsor: Medical University of Vienna

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.

Study Timeline

• Study Start: 2017-03-01
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31
• Study First Submitted: 2023-01-31
• Study First Submitted QC: 2023-01-31
• Study First Posted: 2023-02-09
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-21
• Last Update Posted: 2024-08-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
standard triple IS	ECP (Extracorporeal Photopheresis System)	-
ECP with standard triple IS	ECP (Extracorporeal Photopheresis System)	-

Primary Outcome Measures

Name	Time	Method
Composite endpoint	24 months	the incidence of high-grade ACR, cytomegalovirus (CMV) infection or CLAD

Secondary Outcome Measures

Name	Time	Method
Detection of plasma CMV DNA	24 months	Detection of plasma CMV DNA
Number of AMR episodes	24 months	Number of AMR episodes
Patient survival	36 months	Patient survival
Incidence of de-novo donor specific antibodies	24 months	Incidence of de-novo donor specific antibodies
Graft survival	36 months	Graft survival
Frequency of ACR and of lymphocytic bronchiolitis (LB)	24 months	Frequency of ACR and of lymphocytic bronchiolitis (LB)
Incidence of clinically treated infections	24 months	Incidence of clinically treated infections
Incidence of CLAD	36 months	Incidence of CLAD

Trial Locations

Locations (1)

Medical University Vienna; 🇦🇹 Vienna, Austria