Clinical trial NCT05721079: Extracorporeal Photopheresis (ECP) After Lung Transplantation
Official title: Prophylactic Use of Extracorporeal Photopheresis (ECP) After Lung Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Transplant Infection
Lung Transplant Rejection
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2023-02-09
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Composite endpoint
timeFrame: 24 months
Secondary outcomes:
measure: Frequency of ACR and of lymphocytic bronchiolitis (LB)
timeFrame: 24 months
measure: Incidence of clinically treated infections
timeFrame: 24 months
measure: Detection of plasma CMV DNA
timeFrame: 24 months
measure: Patient survival
timeFrame: 36 months
measure: Graft survival
timeFrame: 36 months
measure: Incidence of de-novo donor specific antibodies
timeFrame: 24 months
measure: Number of AMR episodes
timeFrame: 24 months
measure: Incidence of CLAD
timeFrame: 36 months
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University Vienna
Study officials:
References: