An observational study in Lung Transplant Failure and Rejection and Primary Graft Dysfunction, sponsored by University Hospital, Antwerp. Terminated at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-03.
Sponsored by University Hospital, Antwerp · Observational
Lung transplantation is the ultimate treatment for end stage lung diseases. Survival after lung transplantation is limited mainly due to the development of chronic allograft dysfunction (CLAD). Both acute cellular rejection and primary grade dysfunction (PGD) have been associated with the development of CLAD. In this study we will investigate multiple prognostic factors that influence long term survival after lung transplantation with a specific interest in PGD, acute rejection and the development of CLAD.
At specific time points (according to protocol) exhaled breath, blood specimens, bronchoalveolar lavage and biopsies will be collected. These will be analyzed in an attempt to identify possible biomarkers that will predict the development of PGD and/or CLAD.
26 studies on the registry are indexed under Primary Graft Dysfunction; 4 are open to participants now.
This study's enrollment of 24 is below the median of 60 across 13 observational studies indexed under Primary Graft Dysfunction.
Browse Primary Graft Dysfunction studies →University Hospital, Antwerp is the lead sponsor of 242 studies on the registry; 66 are open to participants now.
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all lung transplant recipients
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Exclusion Criteria:
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Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
identification of possible biomarkers
Other: blood and exhaled breath specimens
identification of possible biomarkers
identify prognostic biomarkers in blood, bronchoalveolar lavage and exhaled breath that will determine long term survival after human lung transplantation.
death
Time frame: up to 520 weeks
Secondary objectives are obtaining information on the development of (Primary graft development) PGD in relationship to respiratory viruses, genetic profile and exhaled breath in patients and (if possible donors) after human lung transplantation.
PGD
Time frame: from transplantation till 72 hours after surgery
This study is terminated, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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University Hospital, Antwerp →