Primary Graft Dysfunction Clinical Trial
Official title:
CLAD: Finding Biomarkers to Predict Rejection and/ or Outcome After Lung Transplantation
| NCT number | NCT04558333 |
| Other study ID # | CLAD |
| Secondary ID | |
| Status | Terminated |
| Phase | |
| First received | |
| Last updated | |
| Start date | October 28, 2019 |
| Est. completion date | February 28, 2024 |
| Verified date | May 2024 |
| Source | University Hospital, Antwerp |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | 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.
| Status | Terminated |
| Enrollment | 24 |
| Est. completion date | February 28, 2024 |
| Est. primary completion date | February 28, 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - all lung transplant recipients > 18 years signed ICF (informed consent form) Exclusion Criteria: - none |
| Country | Name | City | State |
|---|---|---|---|
| Belgium | University Hospital Antwerp | Edegem | Antwerp |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Antwerp |
Belgium,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | identify prognostic biomarkers in blood, bronchoalveolar lavage and exhaled breath that will determine long term survival after human lung transplantation. | death | up to 520 weeks | |
| Secondary | 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 | from transplantation till 72 hours after surgery |
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