Sònia Abilleira1, Natalia Pérez de la Ossa2, Xavier Jiménez3, Pere Cardona4, Dolores Cocho5, Francisco Purroy6, Joaquín Serena7, Luis San Román8, Xabier Urra9, Marta Vilaró10, Jordi Cortés10, José Antonio González10, Ángel Chamorro9, Miquel Gallofré1, Tudor Jovin11, Carlos Molina12, Erik Cobo10, Antoni Dávalos2, Marc Ribó12. 1. Stroke Program, Agency for Health Quality and Assessment of Catalonia, Barcelona, Spain. 2. Department of Neurology, Stroke Unit, Hospital Universitari Germans Trias i Pujol, Badalona, Spain. 3. Emergency Medical Services of Catalonia, Barcelona, Spain. 4. Department of Neurology, Stroke Unit, Hospital Universitari Bellvitge, Barcelona, Spain. 5. Neurology Department. Hospital Granollers, Spain. 6. Department of Neurology, Stroke Unit, Hospital Arnau de Vilanova, Lleida, Spain. 7. Department of Neurology, Stroke Unit, Hospital Josep Trueta, Girona, Spain. 8. Department of Neuroradiology, Hospital Clínic, Barcelona, Spain. 9. Department of Neurology, Stroke Unit, Hospital Clínic, Barcelona, Spain. 10. Statistics and Operational Research, Universitat Politècnica de Catalunya, Barcelona, Spain. 11. Department of Neurological Surgery, Pierre and Marie Curie University, Pittsburgh, PA, USA. 12. Department of Neurology, Stroke Unit, Hospital Universitari Vall d'Hebrón, Barcelona, Spain Sònia Abilleira, Natalia Pérez de la Ossa and Marc Ribó contributed equally to this article.
Abstract
RATIONALE: Optimal pre-hospital delivery pathways for acute stroke patients suspected to harbor a large vessel occlusion have not been assessed in randomized trials. AIM: To establish whether stroke subjects with rapid arterial occlusion evaluation scale based suspicion of large vessel occlusion evaluated by emergency medical services in the field have higher rates of favorable outcome when transferred directly to an endovascular center (endovascular treatment stroke center), as compared to the standard transfer to the closest local stroke center (local-SC). DESIGN: Multicenter, superiority, cluster randomized within a cohort trial with blinded endpoint assessment. PROCEDURE: Eligible patients must be 18 or older, have acute stroke symptoms and not have an immediate life threatening condition requiring emergent medical intervention. They must be suspected to have intracranial large vessel occlusion based on a pre-hospital rapid arterial occlusion evaluation scale of ≥5, be located in geographical areas where the default health authority assigned referral stroke center is a non-thrombectomy capable hospital, and estimated arrival at a thrombectomy capable stroke hospital in less than 7 h from time last seen well. Cluster randomization is performed according to a pre-established temporal sequence (temporal cluster design) with three strata: day/night, distance to the endovascular treatment stroke center, and week/week-end day. STUDY OUTCOME: The primary endpoint is the modified Rankin Scale score at 90 days. The primary safety outcome is mortality at 90 days. ANALYSIS: The primary endpoint based on the modified intention-to-treat population is the distribution of modified Rankin Scale scores at 90 days analyzed under a sequential triangular design. The maximum sample size is 1754 patients, with two planned interim analyses when 701 (40%) and 1227 patients have completed follow-up. Hypothesized common odds ratio is 1.35.
RCT Entities:
RATIONALE: Optimal pre-hospital delivery pathways for acute strokepatients suspected to harbor a large vessel occlusion have not been assessed in randomized trials. AIM: To establish whether stroke subjects with rapid arterial occlusion evaluation scale based suspicion of large vessel occlusion evaluated by emergency medical services in the field have higher rates of favorable outcome when transferred directly to an endovascular center (endovascular treatment stroke center), as compared to the standard transfer to the closest local stroke center (local-SC). DESIGN: Multicenter, superiority, cluster randomized within a cohort trial with blinded endpoint assessment. PROCEDURE: Eligible patients must be 18 or older, have acute stroke symptoms and not have an immediate life threatening condition requiring emergent medical intervention. They must be suspected to have intracranial large vessel occlusion based on a pre-hospital rapid arterial occlusion evaluation scale of ≥5, be located in geographical areas where the default health authority assigned referral stroke center is a non-thrombectomy capable hospital, and estimated arrival at a thrombectomy capable stroke hospital in less than 7 h from time last seen well. Cluster randomization is performed according to a pre-established temporal sequence (temporal cluster design) with three strata: day/night, distance to the endovascular treatment stroke center, and week/week-end day. STUDY OUTCOME: The primary endpoint is the modified Rankin Scale score at 90 days. The primary safety outcome is mortality at 90 days. ANALYSIS: The primary endpoint based on the modified intention-to-treat population is the distribution of modified Rankin Scale scores at 90 days analyzed under a sequential triangular design. The maximum sample size is 1754 patients, with two planned interim analyses when 701 (40%) and 1227 patients have completed follow-up. Hypothesized common odds ratio is 1.35.
Entities:
Keywords:
Acute stroke; clinical trial; drip and ship; large vessel occlusion; mother ship; pre-hospital; transfer models
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