Informations générales (source: ClinicalTrials.gov)
Veno-arterial Extracorporeal Membrane Oxygenation to Reduce Morbidity and Mortality Following Lung Transplant: a Randomized Controlled Trial
Interventional
N/A
Assistance Publique - Hôpitaux de Paris (Voir sur ClinicalTrials)
février 2024
septembre 2027
14 septembre 2025
In patients undergoing lung transplantation (LT), the investigators hypothesize that a
"systematic" intraoperative ECMO strategy would reduce the need for invasive mechanical
ventilation in the first 28 days without increasing adverse events, as compared to an
"on-demand" intraoperative ECMO strategy.
To date, LT remains a highly hazardous procedure. Even if the surgical procedure is well
established, the intraoperative support is not, and most intra-operative ECMO decisions
rely on local protocols, anesthesiologists' habits, and surgeons' preference.
The efficacy of applying a "systematic" strategy on reducing the occurrence of severe
primary graft dysfunction and thus mechanical ventilation in the 28 days following LT,
without increasing mortality or morbidity, would support future guidelines on the use of
ECMO in the intraoperative period of LT for obstructive and restrictive lung diseases.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| HOPITAL FOCH | MESSIKA Jonathan | 18/09/2025 17:33:27 | Contacter | ||
| HOPITAL MARIE LANNELONGUE | MESSIKA Jonathan | 18/09/2025 17:33:27 | Contacter | ||
| AP-HP Assistance publique - Hôpitaux de Paris | 18/09/2025 17:33:27 | Contacter | |||
| AP-HP - Hôpital Bichat | |||||
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| 18/09/2025 17:33:27 | Contact (sur clinicalTrials) | ||||
| 18/09/2025 17:33:27 | Contact (sur clinicalTrials) | ||||
| 18/09/2025 17:33:27 | Contact (sur clinicalTrials) | ||||
| 18/09/2025 17:33:27 | Contact (sur clinicalTrials) | ||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Hôpital FOCH - 92 150 - Suresnes - France | Jonathan MESSIKA, MD | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
Age >18 years Assessed for bilateral sequential lung transplantation for obstructive or
restrictive lung disease Affiliation to the French social security Written informed
consent
Age >18 years Assessed for bilateral sequential lung transplantation for obstructive or
restrictive lung disease Affiliation to the French social security Written informed
consent
At listing :
- a pulmonary hypertension with a mPAP > 45 mmHg, including in the absence of
haemodynamic collapse (MAP, LVEF, RV function all normal)
- a pulmonary hypertension with echocardiographic evidences of right heart dysfunction
(paradoxical septum or RV dilatation or RVEF < 35%)
- a pre-capillary pulmonary hypertension at right heart catheterization with low
cardiac output
- LT for primary pulmonary hypertension
- LT for cystic fibrosis and graft-vs-host disease
- Re-do LT
- Combined multi-organ transplantation
- Active malignancy
- Pregnancy, breastfeeding
- Patients under guardianship (tutelle, curatelle, sauvegarde de justice)
Socondary exclusion criteria:
Patients without pulmonary hypertension or with pulmonary hypertension without right
ventricular dilatation on an echocardiography in the last 6 months will be randomized;
Patients meeting one of the following criteria will not be randomized and will be
secondary excluded from the study :
- preoperative severe pulmonary hypertension with hemodynamic collapse on
echocardiography defined by: paradoxical septum or dilatation of the right ventricle
or RVEF < 20LT in a patient under ECMO as bridge-to-transplantation
- PreLT hypoxemia with PaO2/FiO2 < 80mmHg
- PreLT hypercapnia PaCO2 > 80 mmHg after induction