Transfer to the Local Stroke Center vs Direct Transfer to Endovascular Center of Acute Stroke Patients with Suspected Large Vessel Occlusion in the Catalan Territory (RACECAT): study protocol of a cluster randomized within a cohort trial

Rationale: Optimal pre-hospital delivery pathways for acute stroke patients suspected to harbor a large vessel occlusion (LVO) have not been assessed in randomized trials. Aim: To establish whether stroke subjects with RACE scale based suspicion of LVO evaluated by Emergency Medical Services in the...

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Autores: Abilleira, Sònia, Pérez de la Ossa, Natalia, Jiménez, Xavier, Cardona, Pere, Cocho, Dolores, Purroy Garcia, Francisco, Serena, Joaquín, San Román, Luis, Urra, Xabier, Vilaró, Marta, Cortés Martínez, Jordi, González Alastrué, José Antonio, Chamorro, Ángel, Gallofre, Miquel, Jovin, Tudor G., Molina, Carlos, Cobo Valeri, Erik, Dávalos Errando, Antoni, Ribó, Marc
Tipo de recurso: artículo
Estado:Versión enviada para evaluación y publicación
Fecha de publicación:2019
País:España
Institución:Universitat de Lleida (UdL)
Repositorio:Repositori Obert UdL
OAI Identifier:oai:repositori.udl.cat:10459.1/72913
Acceso en línea:https://doi.org/10.1177/1747493019852176
http://hdl.handle.net/10459.1/72913
Access Level:acceso abierto
Palabra clave:Acute stroke
Large vessel occlusion
Pre-hospital
Transfer models
Drip and ship
Mother ship
Clinical trial
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spelling Transfer to the Local Stroke Center vs Direct Transfer to Endovascular Center of Acute Stroke Patients with Suspected Large Vessel Occlusion in the Catalan Territory (RACECAT): study protocol of a cluster randomized within a cohort trialAbilleira, SòniaPérez de la Ossa, NataliaJiménez, XavierCardona, PereCocho, DoloresPurroy Garcia, FranciscoSerena, JoaquínSan Román, LuisUrra, XabierVilaró, MartaCortés Martínez, JordiGonzález Alastrué, José AntonioChamorro, ÁngelGallofre, MiquelJovin, Tudor G.Molina, CarlosCobo Valeri, ErikDávalos Errando, AntoniRibó, MarcAcute strokeLarge vessel occlusionPre-hospitalTransfer modelsDrip and shipMother shipClinical trialRationale: Optimal pre-hospital delivery pathways for acute stroke patients suspected to harbor a large vessel occlusion (LVO) have not been assessed in randomized trials. Aim: To establish whether stroke subjects with RACE scale based suspicion of LVO evaluated by Emergency Medical Services in the field, have higher rates of favorable outcome when transferred directly to an Endovascular Center (EVT-SC), 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 LVO based on a pre-hospital RACE 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 hours from time last seen well. Cluster randomization is performed according to a pre-established temporal sequence (temporal cluster design) with 3 strata: day/night, distance to the EVT-SC and week/week-end day. Study outcome: The primary endpoint is the modified Rankin Scale (mRS) 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 (mRS) 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.The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: The trial is sponsored by the nonprofit foundation Fundació Privada Ictus Malaltia Vascular, beneficiary of an unrestricted grant by Medtronic. Trial sponsor: Fundació Privada Ictus Malaltia Vascular. Elisabeth Ortínez (eortinez@fundacioictus.com). Study sponsor and funders do not participate in the study design, collection, management, analysis and interpretation of data, writing of the report or the decision to submit results for publication.WileyWorld Stroke OrganizationSAGE Publications2019info:eu-repo/semantics/articleinfo:eu-repo/semantics/submittedVersionhttps://doi.org/10.1177/1747493019852176http://hdl.handle.net/10459.1/72913reponame:Repositori Obert UdL instname:Universitat de Lleida (UdL)InglésVersió preprint del document publicat a: https://doi.org/10.1177/1747493019852176International journal of stroke, 2019, vol. 14, núm. 7, p. 1-25(c) World Stroke Organization, 2019info:eu-repo/semantics/openAccessoai:repositori.udl.cat:10459.1/729132026-06-24T12:42:17Z
dc.title.none.fl_str_mv Transfer to the Local Stroke Center vs Direct Transfer to Endovascular Center of Acute Stroke Patients with Suspected Large Vessel Occlusion in the Catalan Territory (RACECAT): study protocol of a cluster randomized within a cohort trial
title Transfer to the Local Stroke Center vs Direct Transfer to Endovascular Center of Acute Stroke Patients with Suspected Large Vessel Occlusion in the Catalan Territory (RACECAT): study protocol of a cluster randomized within a cohort trial
spellingShingle Transfer to the Local Stroke Center vs Direct Transfer to Endovascular Center of Acute Stroke Patients with Suspected Large Vessel Occlusion in the Catalan Territory (RACECAT): study protocol of a cluster randomized within a cohort trial
Abilleira, Sònia
Acute stroke
Large vessel occlusion
Pre-hospital
Transfer models
Drip and ship
Mother ship
Clinical trial
title_short Transfer to the Local Stroke Center vs Direct Transfer to Endovascular Center of Acute Stroke Patients with Suspected Large Vessel Occlusion in the Catalan Territory (RACECAT): study protocol of a cluster randomized within a cohort trial
title_full Transfer to the Local Stroke Center vs Direct Transfer to Endovascular Center of Acute Stroke Patients with Suspected Large Vessel Occlusion in the Catalan Territory (RACECAT): study protocol of a cluster randomized within a cohort trial
title_fullStr Transfer to the Local Stroke Center vs Direct Transfer to Endovascular Center of Acute Stroke Patients with Suspected Large Vessel Occlusion in the Catalan Territory (RACECAT): study protocol of a cluster randomized within a cohort trial
title_full_unstemmed Transfer to the Local Stroke Center vs Direct Transfer to Endovascular Center of Acute Stroke Patients with Suspected Large Vessel Occlusion in the Catalan Territory (RACECAT): study protocol of a cluster randomized within a cohort trial
title_sort Transfer to the Local Stroke Center vs Direct Transfer to Endovascular Center of Acute Stroke Patients with Suspected Large Vessel Occlusion in the Catalan Territory (RACECAT): study protocol of a cluster randomized within a cohort trial
dc.creator.none.fl_str_mv Abilleira, Sònia
Pérez de la Ossa, Natalia
Jiménez, Xavier
Cardona, Pere
Cocho, Dolores
Purroy Garcia, Francisco
Serena, Joaquín
San Román, Luis
Urra, Xabier
Vilaró, Marta
Cortés Martínez, Jordi
González Alastrué, José Antonio
Chamorro, Ángel
Gallofre, Miquel
Jovin, Tudor G.
Molina, Carlos
Cobo Valeri, Erik
Dávalos Errando, Antoni
Ribó, Marc
author Abilleira, Sònia
author_facet Abilleira, Sònia
Pérez de la Ossa, Natalia
Jiménez, Xavier
Cardona, Pere
Cocho, Dolores
Purroy Garcia, Francisco
Serena, Joaquín
San Román, Luis
Urra, Xabier
Vilaró, Marta
Cortés Martínez, Jordi
González Alastrué, José Antonio
Chamorro, Ángel
Gallofre, Miquel
Jovin, Tudor G.
Molina, Carlos
Cobo Valeri, Erik
Dávalos Errando, Antoni
Ribó, Marc
author_role author
author2 Pérez de la Ossa, Natalia
Jiménez, Xavier
Cardona, Pere
Cocho, Dolores
Purroy Garcia, Francisco
Serena, Joaquín
San Román, Luis
Urra, Xabier
Vilaró, Marta
Cortés Martínez, Jordi
González Alastrué, José Antonio
Chamorro, Ángel
Gallofre, Miquel
Jovin, Tudor G.
Molina, Carlos
Cobo Valeri, Erik
Dávalos Errando, Antoni
Ribó, Marc
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
dc.subject.none.fl_str_mv Acute stroke
Large vessel occlusion
Pre-hospital
Transfer models
Drip and ship
Mother ship
Clinical trial
topic Acute stroke
Large vessel occlusion
Pre-hospital
Transfer models
Drip and ship
Mother ship
Clinical trial
description Rationale: Optimal pre-hospital delivery pathways for acute stroke patients suspected to harbor a large vessel occlusion (LVO) have not been assessed in randomized trials. Aim: To establish whether stroke subjects with RACE scale based suspicion of LVO evaluated by Emergency Medical Services in the field, have higher rates of favorable outcome when transferred directly to an Endovascular Center (EVT-SC), 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 LVO based on a pre-hospital RACE 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 hours from time last seen well. Cluster randomization is performed according to a pre-established temporal sequence (temporal cluster design) with 3 strata: day/night, distance to the EVT-SC and week/week-end day. Study outcome: The primary endpoint is the modified Rankin Scale (mRS) 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 (mRS) 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.
publishDate 2019
dc.date.none.fl_str_mv 2019
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/submittedVersion
format article
status_str submittedVersion
dc.identifier.none.fl_str_mv https://doi.org/10.1177/1747493019852176
http://hdl.handle.net/10459.1/72913
url https://doi.org/10.1177/1747493019852176
http://hdl.handle.net/10459.1/72913
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.relation.none.fl_str_mv Versió preprint del document publicat a: https://doi.org/10.1177/1747493019852176
International journal of stroke, 2019, vol. 14, núm. 7, p. 1-25
dc.rights.none.fl_str_mv (c) World Stroke Organization, 2019
info:eu-repo/semantics/openAccess
rights_invalid_str_mv (c) World Stroke Organization, 2019
eu_rights_str_mv openAccess
dc.publisher.none.fl_str_mv Wiley
World Stroke Organization
SAGE Publications
publisher.none.fl_str_mv Wiley
World Stroke Organization
SAGE Publications
dc.source.none.fl_str_mv reponame:Repositori Obert UdL
instname:Universitat de Lleida (UdL)
instname_str Universitat de Lleida (UdL)
reponame_str Repositori Obert UdL
collection Repositori Obert UdL
repository.name.fl_str_mv
repository.mail.fl_str_mv
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score 15,812429

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