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| Name | Class |
|---|---|
| Medtronic | INDUSTRY |
| Anagram-ESIC | UNKNOWN |
| UPC | UNKNOWN |
| BioClever 2005 S.L. |
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To evaluate the hypothesis that direct transfer to an Endovascular Stroke Center, compared to transfer to the closest Local Stroke Center, offers a better outcome in the distribution of the modified Rankin Scale scores at 90 days in acute ischemic stroke patients with clinically suspected Large Vessel Occlusion identified by Emergency Medical Services (EMS).
Prospective, multicenter, cluster randomized controlled, usual care conditions, open, blinded-endpoint trial of acute stroke patients with suspected acute large vessel occlusion (LVO) identified by EMS at first assistance on the field, in which two strategies will be compared: transfer to the closest local stroke center (Local-SC) Vs. direct transfer to an endovascular stroke center (EVT-SC).
The RACE scale (Rapid Arterial oCclusion Evaluation) will be used as a prehospital screening tool to identify acute stroke patients with suspicion of LVO. Upon candidate identification, EMS will contact a stroke neurologist on call using a prehospital telestroke system who will confirm inclusion criteria and will allocate the subjects to a specific intervention according to a pre-established temporal sequence. Allocation will account for 3 strata: time band (two groups of 12 hours), territory (metropolitan versus provincial area) and week day (working versus weekend day).
Subjects will be followed up to 90 days post-randomization.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transfer to an Endovascular Center | Active Comparator | Acute stroke patients with suspected acute large vessel occlusion identified by EMS at first assistance on the field will be directly transferred to the nearest Endovascular Center bypassing the Local Stroke Center. |
|
| Transfer to the Local Stroke Center | No Intervention | Acute stroke patients with suspected acute large vessel occlusion identified by EMS at first assistance on the field will be transferred to the Local Stroke Center as done accordingly with the current stroke code protocol. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Direct transfer to an Endovascular Center | Other | Cluster randomized controlled study: allocation to active or no intervention arm will be performed accordingly to a pre-established temporal sequence |
| Measure | Description | Time Frame |
|---|---|---|
| modified Rankin Scale score (shift analysis) | Modified Rankin Scale score in ischemic stroke patients as evaluated through a structured telephone-based interview performed by a central assessor who is blinded to group assignment. | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality in all patients | Mortality in all patients included | 90 days |
| Mortality in hemorrhagic stroke patients | Mortality in hemorrhagic stroke patients |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marc Ribó, PhD | Hospital Universitari Vall d'Hebrón, Barcelona, Spain | Principal Investigator |
| Sonia Abilleira, PhD | Pla Director Malaltia Vascular Cerebral. Agència de Qualitat i Avaluació Sanitàries de Catalunya (AQuAS) | Principal Investigator |
| Natalia Pérez de la Ossa, PhD | Hospital Universitari Germans Trias i Pujol, Badalona, Spain | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Germans Trias i Pujol | Badalona | Spain | ||||
| Hospital Bellvitge |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42125807 | Derived | Sapiro N, Kamal N, Abilleira S, Jimenez X, Ramos-Pachon A, Garcia-Tornel A, Perez de la Ossa N, Ribo M, Hill MD, Holodinsky JK. Modeling Prehospital Transportation for Patients With Suspected Acute Ischemic Stroke Due to Large Vessel Occlusion: A Validation Study Using the RACECAT Trial Data. Stroke. 2026 May 13. doi: 10.1161/STROKEAHA.125.054668. Online ahead of print. | |
| 37603325 |
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| 90 days |
| Clinical deterioration requiring orotracheal intubation during transfers | Orotracheal intubation during transfers | 8 hours |
| Clinical deterioration | Clinical deterioration (≥4 points on the NIHSS) | 24 hours |
| Reperfusion therapies | Proportion of patients receiving iv tPA and endovascular treatment within the first 8h from symptom onset | 8 hours |
| Time from symptom onset to reperfusion therapies | Time from symptom onset to iv tPA administration (for patients treated with iv tPA) and to groin puncture (for patients treated with endovascular). | 8 hours |
| Subgroup analysis | Distribution of the modified Rankin Scale score at 90 days (shift analysis) in the following subgroups:
| 90 days |
| Clinical benefit of direct vs. local transfer accordingly with time and distance to the Endovascular Center | To analyze whether an inflection point exists with respect to time from onset to arrival at the Endovascular Center beyond which transfer to a Local-SC is beneficial or equivalent. | 90 days |
| Dramatic early favorable response | Dramatic early favorable response as determined by an NIHSS (National Institute of Health Stroke Scale) of 0-2 or NIHSS improvement ≥ 8 points in ischemic stroke and hemorrhagic stroke patients. | 24 (-2/+12 hours) |
| Barcelona |
| Spain |
| Hospital Clínic | Barcelona | Spain |
| Hospital Mar | Barcelona | Spain |
| Hospital Moisés Broggi | Barcelona | Spain |
| Hospital Santa Creu i Sant Pau | Barcelona | Spain |
| Hospital Vall d'Hebrón | Barcelona | Spain |
| Hospital Josep Trueta | Girona | Spain |
| Hospital Arnau Vilanova | Lleida | Spain |
| Hospital Althaia | Manresa | Spain |
| Mutua Terrassa | Terrassa | Spain |
| Hospital Verge de la Cinta | Tortosa | Spain |
| Derived |
| Ramos-Pachon A, Rodriguez-Luna D, Marti-Fabregas J, Millan M, Bustamante A, Martinez-Sanchez M, Serena J, Terceno M, Vera-Caceres C, Camps-Renom P, Prats-Sanchez L, Rodriguez-Villatoro N, Cardona-Portela P, Urra X, Sola S, Del Mar Escudero M, Salvat-Plana M, Ribo M, Abilleira S, Perez de la Ossa N, Silva Y; RACECAT Trial Investigators. Effect of Bypassing the Closest Stroke Center in Patients with Intracerebral Hemorrhage: A Secondary Analysis of the RACECAT Randomized Clinical Trial. JAMA Neurol. 2023 Oct 1;80(10):1028-1036. doi: 10.1001/jamaneurol.2023.2754. |
| 36848432 | Derived | Garcia-Tornel A, Flores A, Terceno M, Cardona P, Amaro S, Gomis M, Zaragoza J, Krupinski J, Gomez-Choco M, Mas N, Cocho D, Catena E, Purroy F, Deck M, Rubiera M, Pagola J, Rodriguez-Luna D, Juega J, Rodriguez-Villatoro N, Molina CA, Soro C, Jimenez X, Salvat-Plana M, Davalos A, Jovin TG, Abilleira S, Perez de la Ossa N, Ribo M; RACECAT Trial Investigators. Association of Time of Day With Outcomes Among Patients Triaged for a Suspected Severe Stroke in Nonurban Catalonia. Stroke. 2023 Mar;54(3):770-780. doi: 10.1161/STROKEAHA.122.041013. Epub 2023 Feb 27. |
| 36259411 | Derived | Garcia-Tornel A, Millan M, Rubiera M, Bustamante A, Requena M, Dorado L, Olive-Gadea M, Jimenez X, Soto A, Querol M, Hernandez-Perez M, Gomis M, Cardona P, Urra X, Purroy F, Silva Y, Ustrell X, Esteve P, Salvat-Plana M, Gallofre M, Molina C, Davalos A, Jovin T, Abilleira S, Ribo M, Perez de la Ossa N; RACECAT Trial Investigators. Workflows and Outcomes in Patients With Suspected Large Vessel Occlusion Stroke Triaged in Urban and Nonurban Areas. Stroke. 2022 Dec;53(12):3728-3740. doi: 10.1161/STROKEAHA.122.040768. Epub 2022 Oct 19. |
| 36053966 | Derived | Garcia-Tornel A, Sero L, Urra X, Cardona P, Zaragoza J, Krupinski J, Gomez-Choco M, Sala NM, Catena E, Palomeras E, Serena J, Hernandez-Perez M, Boned S, Olive-Gadea M, Requena M, Muchada M, Tomasello A, Molina CA, Salvat-Plana M, Escudero M, Jimenez X, Davalos A, Jovin TG, Purroy F, Abilleira S, Ribo M, de la Ossa NP; RACECAT trial investigators. Workflow Times and Outcomes in Patients Triaged for a Suspected Severe Stroke. Ann Neurol. 2022 Dec;92(6):931-942. doi: 10.1002/ana.26489. Epub 2022 Sep 7. |
| 35510397 | Derived | Perez de la Ossa N, Abilleira S, Jovin TG, Garcia-Tornel A, Jimenez X, Urra X, Cardona P, Cocho D, Purroy F, Serena J, San Roman Manzanera L, Vivanco-Hidalgo RM, Salvat-Plana M, Chamorro A, Gallofre M, Molina CA, Cobo E, Davalos A, Ribo M; RACECAT Trial Investigators. Effect of Direct Transportation to Thrombectomy-Capable Center vs Local Stroke Center on Neurological Outcomes in Patients With Suspected Large-Vessel Occlusion Stroke in Nonurban Areas: The RACECAT Randomized Clinical Trial. JAMA. 2022 May 10;327(18):1782-1794. doi: 10.1001/jama.2022.4404. |
| 31142219 | Derived | Abilleira S, Perez de la Ossa N, Jimenez X, Cardona P, Cocho D, Purroy F, Serena J, Roman LS, Urra X, Vilaro M, Cortes J, Gonzalez JA, Chamorro A, Gallofre M, Jovin T, Molina C, Cobo E, Davalos A, Ribo M. Transfer to the Local Stroke Center versus 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. Int J Stroke. 2019 Oct;14(7):734-744. doi: 10.1177/1747493019852176. Epub 2019 May 29. |
| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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