Protocol for venoarterial ExtraCorporeal Membrane Oxygenation to reduce morbidity and mortality following bilateral lung TransPlantation : the ECMOToP randomised controlled trial
© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ..
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.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2024 |
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| Erschienen: |
2024 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:14 |
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| Enthalten in: |
BMJ open - 14(2024), 3 vom: 05. März, Seite e077770 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Messika, Jonathan [VerfasserIn] |
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| Links: |
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| Themen: |
Adult anaesthesia |
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| Anmerkungen: |
Date Completed 08.03.2024 Date Revised 08.03.2024 published: Electronic ClinicalTrials.gov: NCT05664204 Citation Status MEDLINE |
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| doi: |
10.1136/bmjopen-2023-077770 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM369378237 |
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| 100 | 1 | |a Messika, Jonathan |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Protocol for venoarterial ExtraCorporeal Membrane Oxygenation to reduce morbidity and mortality following bilateral lung TransPlantation |b the ECMOToP randomised controlled trial |
| 264 | 1 | |c 2024 | |
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| 500 | |a Date Revised 08.03.2024 | ||
| 500 | |a published: Electronic | ||
| 500 | |a ClinicalTrials.gov: NCT05664204 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a © Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a TRIAL REGISTRATION NUMBER: NCT05664204 | ||
| 650 | 4 | |a Clinical Trial Protocol | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Adult anaesthesia | |
| 650 | 4 | |a Randomized Controlled Trial | |
| 650 | 4 | |a Thoracic surgery | |
| 650 | 4 | |a Transplant surgery | |
| 700 | 1 | |a Eloy, Philippine |e verfasserin |4 aut | |
| 700 | 1 | |a Boulate, David |e verfasserin |4 aut | |
| 700 | 1 | |a Charvet, Aude |e verfasserin |4 aut | |
| 700 | 1 | |a Fessler, Julien |e verfasserin |4 aut | |
| 700 | 1 | |a Jougon, Jacques |e verfasserin |4 aut | |
| 700 | 1 | |a Lacoste, Philippe |e verfasserin |4 aut | |
| 700 | 1 | |a Mercier, Olaf |e verfasserin |4 aut | |
| 700 | 1 | |a Portran, Philippe |e verfasserin |4 aut | |
| 700 | 1 | |a Roze, Hadrien |e verfasserin |4 aut | |
| 700 | 1 | |a Sage, Edouard |e verfasserin |4 aut | |
| 700 | 1 | |a Thes, Jacques |e verfasserin |4 aut | |
| 700 | 1 | |a Tronc, Francois |e verfasserin |4 aut | |
| 700 | 1 | |a Vourc'h, Mickael |e verfasserin |4 aut | |
| 700 | 1 | |a Montravers, Philippe |e verfasserin |4 aut | |
| 700 | 1 | |a Castier, Yves |e verfasserin |4 aut | |
| 700 | 1 | |a Mal, Herve |e verfasserin |4 aut | |
| 700 | 1 | |a Mordant, Pierre |e verfasserin |4 aut | |
| 700 | 0 | |a Investigators from the ECMOToP Study group |e verfasserin |4 aut | |
| 700 | 1 | |a Mohammed, Nassima Si |e investigator |4 oth | |
| 700 | 1 | |a Cerceau, Pierre |e investigator |4 oth | |
| 700 | 1 | |a Girault, Antoine |e investigator |4 oth | |
| 700 | 1 | |a Roussel, Arnaud |e investigator |4 oth | |
| 700 | 1 | |a Kantor, Elie |e investigator |4 oth | |
| 700 | 1 | |a Lortat-Jacob, Brice |e investigator |4 oth | |
| 700 | 1 | |a Jean-Baptiste, Sylvain |e investigator |4 oth | |
| 700 | 1 | |a Bunel, Vincent |e investigator |4 oth | |
| 700 | 1 | |a Pavlakovic, Isabelle |e investigator |4 oth | |
| 700 | 1 | |a Chesnel, Delphine |e investigator |4 oth | |
| 700 | 1 | |a Didier, Léa |e investigator |4 oth | |
| 700 | 1 | |a Lagreze, Matthias Jacquet |e investigator |4 oth | |
| 700 | 1 | |a Chatron, Eva |e investigator |4 oth | |
| 700 | 1 | |a Vignaux, Claire Merveilleux Du |e investigator |4 oth | |
| 700 | 1 | |a Drevet, Gabrielle |e investigator |4 oth | |
| 700 | 1 | |a Maury, Jean Michel |e investigator |4 oth | |
| 700 | 1 | |a Soldea, Valentin |e investigator |4 oth | |
| 700 | 1 | |a Demant, Xavier |e investigator |4 oth | |
| 700 | 1 | |a Macey, Julie |e investigator |4 oth | |
| 700 | 1 | |a Pellerin, Christelle |e investigator |4 oth | |
| 700 | 1 | |a Ridolfo, Jérôme |e investigator |4 oth | |
| 700 | 1 | |a Blanchard, Elodie |e investigator |4 oth | |
| 700 | 1 | |a Boisselier, Clément |e investigator |4 oth | |
| 700 | 1 | |a Bon, Claire |e investigator |4 oth | |
| 700 | 1 | |a Chevalier, Benjamin |e investigator |4 oth | |
| 700 | 1 | |a Gallo, Eloïse |e investigator |4 oth | |
| 700 | 1 | |a Repusseau, Benjamin |e investigator |4 oth | |
| 700 | 1 | |a Rodriguez, Arnaud |e investigator |4 oth | |
| 700 | 1 | |a Seramondi, Regisse |e investigator |4 oth | |
| 700 | 1 | |a Thumerel, Matthieu |e investigator |4 oth | |
| 700 | 1 | |a Dauriat, Gaelle |e investigator |4 oth | |
| 700 | 1 | |a Delaporte, Amélie |e investigator |4 oth | |
| 700 | 1 | |a Dolidon, Samuel |e investigator |4 oth | |
| 700 | 1 | |a Estephan, Jerome |e investigator |4 oth | |
| 700 | 1 | |a Diop, Sylvain |e investigator |4 oth | |
| 700 | 1 | |a Fabre, Dominique |e investigator |4 oth | |
| 700 | 1 | |a Fadel, Elie |e investigator |4 oth | |
| 700 | 1 | |a Feuillet, Severine |e investigator |4 oth | |
| 700 | 1 | |a Gazengel, Pierre |e investigator |4 oth | |
| 700 | 1 | |a Guirimand, Avit |e investigator |4 oth | |
| 700 | 1 | |a Ion, Iolanda |e investigator |4 oth | |
| 700 | 1 | |a Ionescu, Christian |e investigator |4 oth | |
| 700 | 1 | |a Issard, Justin |e investigator |4 oth | |
| 700 | 1 | |a Pavec, Jérome Le |e investigator |4 oth | |
| 700 | 1 | |a Medraoui, Chahine |e investigator |4 oth | |
| 700 | 1 | |a Menager, Jean-Baptiste |e investigator |4 oth | |
| 700 | 1 | |a Mitilian, Delphine |e investigator |4 oth | |
| 700 | 1 | |a Musat, Andy |e investigator |4 oth | |
| 700 | 1 | |a Nader, Marwan |e investigator |4 oth | |
| 700 | 1 | |a Brioude, Geoffrey |e investigator |4 oth | |
| 700 | 1 | |a Djourno, Xavier |e investigator |4 oth | |
| 700 | 1 | |a Labarriere, Ambroise |e investigator |4 oth | |
| 700 | 1 | |a Mora, Pierre |e investigator |4 oth | |
| 700 | 1 | |a Pastene, Bruno |e investigator |4 oth | |
| 700 | 1 | |a Rivory, Adrien |e investigator |4 oth | |
| 700 | 1 | |a Thomas, Pascal-Alexandre |e investigator |4 oth | |
| 700 | 1 | |a Cadiet, Julien |e investigator |4 oth | |
| 700 | 1 | |a Groleau, Nicolas |e investigator |4 oth | |
| 700 | 1 | |a Lepoivre, Thierry |e investigator |4 oth | |
| 700 | 1 | |a Roux, Antoine |e investigator |4 oth | |
| 700 | 1 | |a Miranda, Sandra de |e investigator |4 oth | |
| 700 | 1 | |a Picard, Clément |e investigator |4 oth | |
| 700 | 1 | |a Beaumont, Laurence |e investigator |4 oth | |
| 700 | 1 | |a Brugière, Olivier |e investigator |4 oth | |
| 700 | 1 | |a Verdière, Sylvie Colin de |e investigator |4 oth | |
| 700 | 1 | |a Hamid, Abdul-Momen |e investigator |4 oth | |
| 700 | 1 | |a Parquin, François |e investigator |4 oth | |
| 700 | 1 | |a Hamdan, Amer |e investigator |4 oth | |
| 700 | 1 | |a Zuber, Benjamin |e investigator |4 oth | |
| 700 | 1 | |a Cerf, Charles |e investigator |4 oth | |
| 700 | 1 | |a Devaquet, Jérôme |e investigator |4 oth | |
| 700 | 1 | |a Galliot, Richard |e investigator |4 oth | |
| 700 | 1 | |a Tachon, Guillaume |e investigator |4 oth | |
| 700 | 1 | |a Mayenco-Cardenal, Nicolas |e investigator |4 oth | |
| 700 | 1 | |a Phillips-Houlbracq, Mathilde |e investigator |4 oth | |
| 700 | 1 | |a Cortier, David |e investigator |4 oth | |
| 700 | 1 | |a Cohen, Johanna |e investigator |4 oth | |
| 700 | 1 | |a Paternot, Alexis |e investigator |4 oth | |
| 700 | 1 | |a Pricopi, Ciprian |e investigator |4 oth | |
| 700 | 1 | |a Cassiano, Francesco |e investigator |4 oth | |
| 700 | 1 | |a Glorion, Matthieu |e investigator |4 oth | |
| 700 | 1 | |a Wolf, Julien De |e investigator |4 oth | |
| 700 | 1 | |a Mimbimi, Chloé |e investigator |4 oth | |
| 700 | 1 | |a Guen, Morgan Le |e investigator |4 oth | |
| 700 | 1 | |a Dumans, Virginie |e investigator |4 oth | |
| 700 | 1 | |a Jacqmin, Sébastien |e investigator |4 oth | |
| 700 | 1 | |a Finet, Michael |e investigator |4 oth | |
| 700 | 1 | |a Goncalves, Sindia |e investigator |4 oth | |
| 700 | 1 | |a Grosz, Louis |e investigator |4 oth | |
| 700 | 1 | |a Hickel, Charles |e investigator |4 oth | |
| 700 | 1 | |a Josserand, Julien |e investigator |4 oth | |
| 700 | 1 | |a Richard, Julien |e investigator |4 oth | |
| 700 | 1 | |a Weisenburger, Gaëlle |e investigator |4 oth | |
| 700 | 1 | |a Snauwaert, Aurélie |e investigator |4 oth | |
| 700 | 1 | |a Boudinet, Sandrine |e investigator |4 oth | |
| 700 | 1 | |a Atchade, Enora |e investigator |4 oth | |
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