Veno-arterial ExtraCorporeal Membrane Oxygenation to Reduce Morbidity and Mortality Following Lung TransPlant

Recruiting now · Not applicable

Conditions studied: The Number of Ventilator-free Days in the 28 Days Following LT

In brief

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.

Key facts

Study ID

NCT05664204

Run by

Assistance Publique - Hôpitaux de Paris

People needed

200

Starts

2024-02-29

Expected to finish

2027-09-28

Last updated by the study team

2024-05-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age >18 years Assessed for bilateral sequential lung transplantation for obstructive or restrictive lung disease Affiliation to the French social security Written informed consent

You may not qualify if…

• 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

Where it is running

• Hôpital Bichat Claude Bernard — Paris, France (enrolling)
• Hôpital FOCH — Suresnes, France

Full record on ClinicalTrials.gov

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