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

RecruitingNAAges 18 Years - anyAllAssistance Publique - Hôpitaux de Paris
NCT05664204 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 d

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📋 Eligibility rules (as published)
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 Exclusion Criteria: 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
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What it tests

  • Veno-arterial extracorporeal membrane oxygenation
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Where

2 sites
Hôpital Bichat Claude Bernard
Paris, France
Hôpital FOCH
Suresnes, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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