학술논문
Direct transfer to angiosuite for patients with severe acute stroke treated with thrombectomy: the multicentre randomised controlled DIRECT ANGIO trial protocol
Document Type
article
Author
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
Source
BMJ Open, Vol 11, Iss 3 (2021)
Subject
Language
English
ISSN
2044-6055
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.