Protocol for venoarterial ExtraCorporeal Membrane Oxygenation to reduce morbidity and mortality following bilateral lung TransPlantation: the ECMOToP randomised controlled trial.

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. 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. 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. NCT05664204.

Messika J ，Eloy P ，Boulate D ，Charvet A ，Fessler J ，Jougon J ，Lacoste P ，Mercier O ，Portran P ，Roze H ，Sage E ，Thes J ，Tronc F ，Vourc'h M ，Montravers P ，Castier Y ，Mal H ，Mordant P ，Investigators from the ECMOToP Study group ... -  《BMJ Open》

Defining the optimum strategy for identifying adults and children with coeliac disease: systematic review and economic modelling.

Elwenspoek MM ，Thom H ，Sheppard AL ，Keeney E ，O'Donnell R ，Jackson J ，Roadevin C ，Dawson S ，Lane D ，Stubbs J ，Everitt H ，Watson JC ，Hay AD ，Gillett P ，Robins G ，Jones HE ，Mallett S ，Whiting PF ... -  《-》

Bortezomib in multiple myeloma and lymphoma: a systematic review and clinical practice guideline.

Reece D ，Imrie K ，Stevens A ，Smith CA ，Hematology Disease Site Groupof Cancer Care Ontario’s Program in Evidence-based Care ... -  《Current Oncology》

Lamotrigine versus levetiracetam or zonisamide for focal epilepsy and valproate versus levetiracetam for generalised and unclassified epilepsy: two SANAD II non-inferiority RCTs.

Marson AG ，Burnside G ，Appleton R ，Smith D ，Leach JP ，Sills G ，Tudur-Smith C ，Plumpton CO ，Hughes DA ，Williamson PR ，Baker G ，Balabanova S ，Taylor C ，Brown R ，Hindley D ，Howell S ，Maguire M ，Mohanraj R ，Smith PE ... -  《-》

Medications for chronic obstructive pulmonary disease: a historical non-interventional cohort study with validation against RCT results.

Wing K ，Williamson E ，Carpenter JR ，Wise L ，Schneeweiss S ，Smeeth L ，Quint JK ，Douglas I ... -  《-》