Direct Transfer to an Endovascular Center Compared to Transfer to the Closest Stroke Center in Acute Stroke Patients With Suspected Large Vessel Occlusion

NCT02795962 | Completed DMC

• 1 other identifier: RACECAT
• Study Type: interventional
• Target: 1,401
• Locations: 1 country
• Sites: 12

Brief Summary

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).

Conditions

Stroke

Keywords

Endovascular Procedures; Emergency Medical Services

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (9)

• Mortality in all patients

  90 days

• Mortality in hemorrhagic stroke patients

  90 days

• Clinical deterioration requiring orotracheal intubation during transfers

  8 hours

• Clinical deterioration

  24 hours

• Reperfusion therapies

  8 hours

Study Arms (2)

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.

Other: Direct transfer to an Endovascular 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.

Interventions

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

Transfer to an Endovascular Center

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Suspected LVO acute stroke patients identified by a RACE scale score \>4 at the pre-hospital setting, that is evaluated by EMS professionals when attending patients, in non-stroke ready centers or primary health centers, previous to the transfer to a stroke center.
• Patients located in geographical areas in which the reference stroke center is a hospital not capable to offer endovascular treatment (Primary stroke Center or Telestroke Center).
• Estimated arrival time at an EVT-SC \<7 hours from symptom onset. Symptom onset is defined as point in time the patient was last seen well (at baseline).
• No significant pre-stroke functional disability (modified Rankin scale 0 - 2)
• Age ≥18
• Deferred informed consent obtained from patient or acceptable patient surrogate (after the acute phase, as permission to use clinical data within a clinical registry)

You may not qualify if:

• Patients in a coma (NIHSS item of consciousness \>1)
• Patients with unstable clinical status who require emergent life support care
• Serious, advanced, or terminal illness with anticipated life expectancy of less than 6 month.
• Suspected LVO acute stroke patients identified at the Emergency Department of a stroke center
• Subject participating in a study involving an investigational drug or device that would impact this study.
• Patients with a pre-existing neurological or psychiatric disease that would confound the neurological or functional evaluations. This excludes patients who are severely demented, require constant assistance in a nursing home type setting or who live at home but are not fully independent in activities of daily living (toileting, dressing, eating, cooking and preparing meals, etc.)
• Unlikely to be available for 90-day follow-up (e.g. no fixed home address, visitor from overseas).

Sponsors & Collaborators

• Fundacio Ictus Malaltia Vascular: lead
• Medtronic: collaborator
• Anagram-ESIC: collaborator
• UPC: collaborator
• BioClever 2005 S.L.: collaborator

Study Sites (12)

Hospital Germans Trias i Pujol

Badalona, Spain

Location

Hospital Bellvitge

Barcelona, Spain

Location

Hospital Clínic

Barcelona, Spain

Location

Hospital Mar

Barcelona, Spain

Location

Hospital Moisés Broggi

Barcelona, Spain

Location

Hospital Santa Creu i Sant Pau

Barcelona, Spain

Location

Hospital Vall d'Hebrón

Barcelona, Spain

Location

Hospital Josep Trueta

Girona, Spain

Location

Hospital Arnau Vilanova

Lleida, Spain

Location

Hospital Althaia

Manresa, Spain

Location

Mutua Terrassa

Terrassa, Spain

Location

Hospital Verge de la Cinta

Tortosa, Spain

Location

Related Publications (6)

• 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.

  PMID: 37603325 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.

  PMID: 36848432 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.

  PMID: 36259411 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.

  PMID: 36053966 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.

  PMID: 35510397 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.

  PMID: 31142219 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2016
• First Posted: June 10, 2016
• Study Start: March 1, 2017
• Primary Completion: October 1, 2020
• Study Completion: October 1, 2020
• Last Updated: March 16, 2021

Record last verified: 2021-03

Locations

ES (12)