1. Protocol for venoarterial ExtraCorporeal Membrane Oxygenation to reduce morbidity and mortality following bilateral lung TransPlantation: the ECMOToP randomised controlled trial
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Richard Galliot, Jonathan Messika, Jérôme Devaquet, Jérome Ridolfo, Hervé Mal, Séverine Feuillet, François Tronc, Pascal-Alexandre Thomas, Edouard Sage, Philippe Montravers, Jacques Jougon, Elodie Blanchard, Enora Atchade, Philippine Eloy, Bruno Pastene, Nassima Si Mohammed, Pierre Gazengel, Charles Cerf, David Boulate, Justin Issard, Elie Fadel, Olaf Mercier, Brice Lortat-Jacob, Sylvain Jean-Baptiste, Aurelie Snauwaert, Yves Castier, Elie Kantor, Sandrine Boudinet, Pierre Mordant, Antoine Girault, Arnaud Roussel, Aude Charvet, Julien Fessler, Philippe Lacoste, Philippe Portran, Hadrien Roze, Jacques Thes, Mickael Vourc'h, Pierre Cerceau, Vincent Bunel, Isabelle Pavlakovic, Delphine Chesnel, Léa Didier, Matthias Jacquet Lagreze, Eva Chatron, Claire Merveilleux Du Vignaux, Gabrielle Drevet, Jean Michel Maury, Valentin Soldea, Xavier Demant, Julie Macey, Christelle Pellerin, Clément Boisselier, Claire Bon, Benjamin Chevalier, Eloïse Gallo, Benjamin Repusseau, Arnaud Rodriguez, Regisse Seramondi, Matthieu Thumerel, Gaelle Dauriat, Amélie Delaporte, Samuel Dolidon, Jerome Estephan, Sylvain Diop, Dominique Fabre, Avit Guirimand, Iolanda Ion, Christian Ionescu, Jérome Le Pavec, Chahine Medraoui, Jean-Baptiste Menager, Delphine Mitilian, Andy Musat, Marwan Nader, Geoffrey Brioude, Xavier Djourno, Ambroise Labarriere, Pierre Mora, Adrien Rivory, Julien Cadiet, Nicolas Groleau, Thierry Lepoivre, Antoine Roux, Sandra de Miranda, Clément Picard, Laurence Beaumont, Olivier Brugière, Sylvie Colin de Verdière, Abdul-Momen Hamid, François Parquin, Amer Hamdan, Benjamin Zuber, Guillaume Tachon, Nicolas Mayenco-Cardenal, Mathilde Phillips-Houlbracq, David Cortier, Johanna Cohen, Alexis Paternot, Ciprian Pricopi, Francesco Cassiano, Matthieu Glorion, Julien De Wolf, Chloé Mimbimi, Morgan Le Guen, Virginie Dumans, Sébastien Jacqmin, Michael Finet, Sindia Goncalves, Louis Grosz, Charles Hickel, Julien Josserand, Julien Richard, and Gaëlle Weisenburger
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Medicine - Abstract
Introduction Lung transplantation (LTx) aims at improving survival and quality of life for patients with end-stage lung diseases. Venoarterial extracorporeal membrane oxygenation (VA-ECMO) is used as intraoperative support for LTx, despite no precise guidelines for its initiation. We aim to evaluate two strategies of VA-ECMO initiation in the perioperative period in patients with obstructive or restrictive lung disease requiring bilateral LTx. In the control ‘on-demand’ arm, high haemodynamic and respiratory needs will dictate VA-ECMO initiation; in the experimental ‘systematic’ arm, VA-ECMO will be pre-emptively initiated. We hypothesise a ‘systematic’ strategy will increase the number of ventilatory-free days at day 28.Methods and analysis We designed a multicentre randomised controlled trial in parallel groups. Adult patients with obstructive or restrictive lung disease requiring bilateral LTx, without a formal indication for pre-emptive VA-ECMO before LTx, will be included. Patients with preoperative pulmonary hypertension with haemodynamic collapse, ECMO as a bridge to transplantation, severe hypoxaemia or hypercarbia will be secondarily excluded. In the systematic group, VA-ECMO will be systematically implanted before the first pulmonary artery cross-clamp. In the on-demand group, VA-ECMO will be implanted intraoperatively if haemodynamic or respiratory indices meet preplanned criteria. Non-inclusion, secondary exclusion and VA-ECMO initiation criteria were validated by a Delphi process among investigators. Postoperative weaning of ECMO and mechanical ventilation will be managed according to best practice guidelines. The number of ventilator-free days at 28 days (primary endpoint) will be compared between the two groups in the intention-to-treat population. Secondary endpoints encompass organ failure occurrence, day 28, day 90 and year 1 vital status, and adverse events.Ethics and dissemination The sponsor is the Assistance Publique–Hôpitaux de Paris. The ECMOToP protocol version 2.1 was approved by Comité de Protection des Personnes Ile de France VIII. Results will be published in international peer-reviewed medical journals.Trial registration number NCT05664204.
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- 2024
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