1. Direct transfer to angiosuite for patients with severe acute stroke treated with thrombectomy: the multicentre randomised controlled DIRECT ANGIO trial protocol
- Author
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Isabelle Serre, Thierry Moulin, Guillaume Charbonnier, Mariano Musacchio, Aboubaker Cherifi, Solene Moulin, Giovanni Vitale, Lionel Nace, Hamza Achit, Olivier Beaufils, Thomas Loeb, Dominique Cailloce, Thibaut Desmettre, Xavier Combes, Ariel Pablo Lebedinsky, Francis Vuillemet, Nicolas Kempf, Philippe Lemmel, Eric Schluck, Fortunato Di Caterino, Panagiotis Primikiris, Elisabeth de Bustos Medeiros, Benjamin Bouamra, Louise Bonnet, Fabrice Vuillier, Pablo A Lebedinsky, Frederico Bolognini, Elie Cohen-Khallas, Andreas Fickl, Mathilde Goudot, Sylvie Courtois, Sohrab Mostoufizadehghalamfarsa, Alessandro La Porta, Nathalie Caucheteux, Vi Tuan Hua, Mickaël Hoang, Catherine Pradeau, Jean-Marc Mene, Musa Sesay, Aymerci Rouchaud, BIRKER, Juliette, Service de neurologie [CHRU Nancy], Centre Hospitalier Régional Universitaire de Nancy (CHRU Nancy), Imagerie Adaptative Diagnostique et Interventionnelle (IADI), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Lorraine (UL), Département de neuroradiologie diagnostique et thérapeutique [CHRU Nancy], Centre d'Investigation Clinique - Innovation Technologique [Nancy] (CIC-IT), Centre d'investigation clinique [Nancy] (CIC), Centre Hospitalier Régional Universitaire de Nancy (CHRU Nancy)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Lorraine (UL)-Centre Hospitalier Régional Universitaire de Nancy (CHRU Nancy)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Lorraine (UL), Service de Réanimation Médicale [CHRU Nancy], Centre d'investigation clinique - Epidémiologie clinique [Nancy] (CIC-EC), Département de Neuroradiologie[Montpellier], Université Montpellier 1 (UM1)-Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier)-Hôpital Gui de Chauliac [Montpellier]-Université de Montpellier (UM), Département de neurologie [Montpellier], Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Service Neuroradiologie diagnostique et interventionnelle [Hôpital Foch], Hôpital Foch [Suresnes], SAMU 92 [Garches], Hôpital Raymond Poincaré [AP-HP], Service de Neuroradiologie interventionnelle [CHU Limoges], CHU Limoges, Service de Neurologie [CHU Limoges], SAMU/SMUR [Limoges], Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon), CHU Bordeaux [Bordeaux], CH Colmar, Centre Hospitalier Universitaire de Reims (CHU Reims), Hôpital Rothschild [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Groupe hospitalier de la région de Mulhouse Sud-Alsace (GHRMSA), and Hôpital Gui de Chauliac [Montpellier]-Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier)-Université Montpellier 1 (UM1)-Université de Montpellier (UM)
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medicine.medical_specialty ,medicine.medical_treatment ,[INFO.INFO-IM] Computer Science [cs]/Medical Imaging ,[SDV.IB.MN]Life Sciences [q-bio]/Bioengineering/Nuclear medicine ,Direct transfer ,Brain Ischemia ,[SDV.IB.MN] Life Sciences [q-bio]/Bioengineering/Nuclear medicine ,03 medical and health sciences ,0302 clinical medicine ,Quality of life ,Modified Rankin Scale ,interventional radiology ,medicine ,[INFO.INFO-IM]Computer Science [cs]/Medical Imaging ,Humans ,Multicenter Studies as Topic ,030212 general & internal medicine ,Prospective Studies ,Acute stroke ,Randomized Controlled Trials as Topic ,Thrombectomy ,clinical trials ,[SDV.MHEP] Life Sciences [q-bio]/Human health and pathology ,medicine.diagnostic_test ,business.industry ,Endovascular Procedures ,Interventional radiology ,General Medicine ,Emergency department ,Thrombolysis ,3. Good health ,Clinical trial ,Stroke ,Treatment Outcome ,Neurology ,Emergency medicine ,Quality of Life ,stroke medicine ,Medicine ,France ,business ,030217 neurology & neurosurgery ,[SDV.MHEP]Life Sciences [q-bio]/Human health and pathology - Abstract
IntroductionMechanical 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 analysisDIRECT 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 disseminationThe 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 numberNCT03969511.
- Published
- 2021
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