Lung Transplant Rejection Clinical Trial
Official title:
Prophylactic Use of Extracorporeal Photopheresis (ECP) After Lung Transplantation
Verified date | January 2023 |
Source | Medical University of Vienna |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 62 |
Est. completion date | December 31, 2022 |
Est. primary completion date | December 31, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Austria | Medical University Vienna | Vienna |
Lead Sponsor | Collaborator |
---|---|
Medical University of Vienna |
Austria,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | acute cellular rejection | patients with acute rejection, biopsy proven with ISHLT grade > 1 histology | 12 months |
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