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Direct transfer to angiosuite for patients with severe acute stroke treated with thrombectomy: the multicentre randomised controlled DIRECT ANGIO trial protocol

Nolwenn Riou-Comte 1 François Zhu 2, 3 Aboubaker Cherifi 4 Sébastien Richard 1 Lionel Nace 5 Gérard Audibert 5 Hamza Achit 6 Vincent Costalat 7 Caroline Arquizan 8 Olivier Beaufils 9 Arturo Consoli 10, 11 Bertrand Lapergue 10 Thomas Loeb 12 Aymeric Rouchaud 13 Francisco Macian 14 Dominique Cailloce 15 Alessandra Biondi 16 Thierry Moulin 16 Thibaut Desmettre 16 Gaultier Marnat 17 Igor Sibon 17 Xavier Combes 17 Ariel Lebedinsky 18 Francis Vuillemet 18 Nicolas Kempf 18 Laurent Pierot 19 Solene Moulin 19 Philippe Lemmel 19 Mikael Mazighi 20 Raphael Blanc 20 Candice Sabben 20 Eric Schluck 21 Serge Bracard 2, 3 René Anxionnat 2, 3 Francis Guillemin 6 Gabriela Hossu 2, 4 Benjamin Gory 2, 3
Abstract : Introduction Mechanical thrombectomy (MT) increases functional independence in patients with acute ischaemic stroke with anterior circulation large vessel occlusion (LVO), and the probability to achieve functional independence decreases by 20% for each 1-hour delay to reperfusion. Therefore, we aim to investigate whether direct angiosuite transfer (DAT) is superior to standard imaging/emergency department-based management in achieving 90-day functional independence in patients presenting with an acute severe neurological deficit likely due to LVO and requiring emergent treatment with MT. Methods and analysis DIRECT ANGIO (Effect of DIRECT transfer to ANGIOsuite on functional outcome in patient with severe acute stroke treated with thrombectomy: the randomised DIRECT ANGIO Trial) trial is an investigator-initiated, multicentre, prospective, randomised, open-label, blinded endpoint (PROBE) study. Eligibility requires a patient ≤75 years, pre-stroke modified Rankin Scale (mRS) 0–2, presenting an acute severe neurological deficit and admitted within 5 hours of symptoms onset in an endovascular-capable centre. A total of 208 patients are randomly allocated in a 1:1 ratio to DAT or standard management. The primary outcome is the rate of patients achieving a functional independence, assessed as mRS 0–2 at 90 days. Secondary endpoints include patients presenting confirmed LVO, patients eligible to intravenous thrombolysis alone, patients with intracerebral haemorrhage and stroke-mimics, intrahospital time metrics, early neurological improvement (reduction in National Institutes of Health Stroke Scale by ≥8 points or reaching 0–1 at 24 hours) and mRS overall distribution at 90 days and 12 months. Safety outcomes are death and intracerebral haemorrhage transformation. Medico-economics analyses include health-related quality of life and cost utility assessment. Ethics and dissemination The DIRECT ANGIO trial was approved by the ethics committee of Ile de France 1. Study began in April 2020. Results will be published in an international peer-reviewed medical journal. Trial registration number NCT03969511 .
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Submitted on : Friday, May 28, 2021 - 10:52:44 AM
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Nolwenn Riou-Comte, François Zhu, Aboubaker Cherifi, Sébastien Richard, Lionel Nace, et al.. Direct transfer to angiosuite for patients with severe acute stroke treated with thrombectomy: the multicentre randomised controlled DIRECT ANGIO trial protocol. BMJ Open, BMJ Publishing Group, 2021, 11 (3), pp.e040522. ⟨10.1136/bmjopen-2020-040522⟩. ⟨hal-03240602⟩

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