Extracorporeal Photopheresis (ECP) After Lung Transplantation

Not Applicable

Completed

• Conditions: Lung Transplant Infection; Lung Transplant Rejection

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-1-31
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

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

Inclusion Criteria

Inclusion Criteria:<br><br> - Patients undergoing first lung transplantation<br><br> - Patient underlying disease COPD<br><br> - Male or female be 18 years or older<br><br> - Patients (male and female) must agree to use an acceptable method of birth control<br> the treatment period of 3 months and 3 months afterward<br><br> - Patients must have a body weight more than 40 kg<br><br> - Patients must have a platelet count more than 20.000/cmm<br><br> - Patients must be willing and capable of understanding the purpose and risks of the<br> study and must sign a statement of informed consent<br><br>Exclusion Criteria:<br><br> - Previous organ transplantation<br><br> - Women who are pregnant and/or lactating<br><br> - Patients with hypersensitivity or allergy to both heparin and citrate products<br><br> - Patients who are unable to tolerate extracorporeal volume shifts associated with ECP<br> treatment due to the presence of any of the following conditions: uncompensated<br> congestive heart failure, pulmonary edema, renal failure or hepatic failure

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Composite endpoint

Secondary Outcome Measures

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