Clinical trial NCT02795962: Direct Transfer to an Endovascular Center Compared to Transfer to the Closest Stroke Center in Acute Stroke Patients With Suspected Large Vessel Occlusion
Official title: A Trial Comparing Transfer to the Closest Local Stroke Center vs. Direct Transfer to Endovascular Stroke Center of Acute Stroke Patients With Suspected Large Vessel Occlusion in the Catalan Territory.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Endovascular Procedures
Emergency Medical Services
Lead sponsor: Fundacio Ictus Malaltia Vascular
Sponsor class: OTHER
Collaborators: name: Medtronic
name: Anagram-ESIC
name: UPC
name: BioClever 2005 S.L.
First posted: 2016-06-10
Enrollment: 1401
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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).

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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).

Primary outcomes:
measure: modified Rankin Scale score (shift analysis)
timeFrame: 90 days
Secondary outcomes:
measure: Mortality in all patients
timeFrame: 90 days
measure: Mortality in hemorrhagic stroke patients
timeFrame: 90 days
measure: Clinical deterioration requiring orotracheal intubation during transfers
timeFrame: 8 hours
measure: Clinical deterioration
timeFrame: 24 hours
measure: Reperfusion therapies
timeFrame: 8 hours
measure: Time from symptom onset to reperfusion therapies
timeFrame: 8 hours
measure: Subgroup analysis
timeFrame: 90 days
measure: Clinical benefit of direct vs. local transfer accordingly with time and distance to the Endovascular Center
timeFrame: 90 days
measure: Dramatic early favorable response
timeFrame: 24 (-2/+12 hours)
Other outcomes:
Locations:
city: Badalona
country: Spain
facility: Hospital Germans Trias i Pujol
city: Barcelona
country: Spain
facility: Hospital Bellvitge
city: Barcelona
country: Spain
facility: Hospital Clínic
city: Barcelona
country: Spain
facility: Hospital Mar
city: Barcelona
country: Spain
facility: Hospital Moisés Broggi
city: Barcelona
country: Spain
facility: Hospital Santa Creu i Sant Pau
city: Barcelona
country: Spain
facility: Hospital Vall d'Hebrón
city: Girona
country: Spain
facility: Hospital Josep Trueta
city: Lleida
country: Spain
facility: Hospital Arnau Vilanova
city: Manresa
country: Spain
facility: Hospital Althaia
city: Terrassa
country: Spain
facility: Mutua Terrassa
city: Tortosa
country: Spain
facility: Hospital Verge de la Cinta
Study officials:
affiliation: Hospital Universitari Vall d'Hebrón, Barcelona, Spain
name: Marc Ribó, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Pla Director Malaltia Vascular Cerebral. Agència de Qualitat i Avaluació Sanitàries de Catalunya (AQuAS)
name: Sonia Abilleira, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitari Germans Trias i Pujol, Badalona, Spain
name: Natalia Pérez de la Ossa, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.