Informations générales (source: ClinicalTrials.gov)

NCT03702257 En recrutement
Intérêt Diagnostique et Pronostique de la présence d'Anticorps spécifiques du Donneur Intra-greffon Dans le Rejet Humoral en Transplantation Pulmonaire
Interventional
N/A
University Hospital, Strasbourg, France (Voir sur ClinicalTrials)
août 2019
février 2026
29 juin 2024
The diagnosis of AMR in lung transplant recipients is difficult and often comes too late, because of lack of standardized definition. The diagnosis is nowadays based on an expert multidisciplinary approach involving clinical, histopathological and immunological criteria. Hypothesis: the presence of intragraft donor specific antibodies (gDSAs) could be used as a new diagnostic tool for AMR in lung transplant recipients Study Objectives: to evaluate, in lung transplant patients with circulating DSAs, the diagnostic value of gDSAs in AMR and to analyze its prognostic value on graft outcome.

Etablissements

Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données
HOPITAL FOCH ANTOINE ROUX Active, sans recrutement 05/05/2025 07:12:02  Contacter
Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
AP-HP - Hôpital Bichat Olivier BRUGIERE Recrutement non commencé Contact (sur clinicalTrials)
Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
CHU Nord - 13915 - Marseille - France Martine REYNAUD GAUBERT En recrutement Contact (sur clinicalTrials)
Les Hôpitaux Universitaires de Strasbourg - 67091 - Strasbourg - France Sandrine HIRSCHI En recrutement Contact (sur clinicalTrials)

Critères

Tous
Inclusion criteria:

- Patient older than 18 years

- Transplanted pulmonary or cardiopulmonary patient

- And developing circulating anti-HLA antibodies directed against the graft or "DSA"
at a threshold > 1000 of MFI in the 30 days preceding the inclusion visit

- Affiliation to the French social security

- Patient able to understand the objectives and risks related to research and to give
informed, dated and signed consent



- Patient whose anti-HLA antibodies are not directed against the graft (no DSA)

- Contraindication to performing a bronchial fibroscopy with transbronchial biopsies

- Treatment with intravenous immunoglobulin (less than 1 month before inclusion) or
Rituximab (less than 6 months before inclusion)

- Plasma exchanges (less than 3 months before inclusion)

- Risk of bleeding predictable (crushing disorder, impossibility of stopping the
offending treatments)

- Impossibility of giving the subject informed information

- Subject under the protection of justice Subject under guardianship or curatorship

- Pregnancy

- Breastfeeding