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

• ClinicalTrials.gov Identifier: NCT02795962
• Recruitment Status: Completed
• First Posted: June 10, 2016
• Last Update Posted: March 16, 2021
• Sponsor: Fundacio Ictus Malaltia Vascular
• Collaborators: Medtronic; Anagram-ESIC; UPC; BioClever 2005 S.L.
• Information provided by (Responsible Party): Fundacio Ictus Malaltia Vascular

Study Description

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).

Condition or disease	Intervention/treatment	Phase
Stroke	Other: Direct transfer to an Endovascular Center	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 1401 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Health Services Research
• 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.
• Actual Study Start Date: March 1, 2017
• Actual Primary Completion Date: October 1, 2020
• Actual Study Completion Date: October 1, 2020

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Transfer to an Endovascular Center; 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; Cluster randomized controlled study: allocation to active or no intervention arm will be performed accordingly to a pre-established temporal sequence
No Intervention: Transfer to the Local Stroke Center; 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.

Outcome Measures

Primary Outcome Measures :

1. modified Rankin Scale score (shift analysis) [ Time Frame: 90 days ]
   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.

Secondary Outcome Measures :

1. Mortality in all patients [ Time Frame: 90 days ]
   Mortality in all patients included
2. Mortality in hemorrhagic stroke patients [ Time Frame: 90 days ]
   Mortality in hemorrhagic stroke patients
3. Clinical deterioration requiring orotracheal intubation during transfers [ Time Frame: 8 hours ]
   Orotracheal intubation during transfers
4. Clinical deterioration [ Time Frame: 24 hours ]
   Clinical deterioration (≥4 points on the NIHSS)
5. Reperfusion therapies [ Time Frame: 8 hours ]
   Proportion of patients receiving iv tPA and endovascular treatment within the first 8h from symptom onset
6. Time from symptom onset to reperfusion therapies [ Time Frame: 8 hours ]
   Time from symptom onset to iv tPA administration (for patients treated with iv tPA) and to groin puncture (for patients treated with endovascular).
7. Subgroup analysis [ Time Frame: 90 days ]

   Distribution of the modified Rankin Scale score at 90 days (shift analysis) in the following subgroups:

   • Ischemic / hemorrhagic
   • Patients eligible for iv t-PA vs. non iv t-PA eligible when attended by EMS (within time window considering transfer time to the nearest SC, no formal contraindications as recent major surgery or anticoagulation)
   • Patients treated with EVT
8. Clinical benefit of direct vs. local transfer accordingly with time and distance to the Endovascular Center [ Time Frame: 90 days ]
   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.
9. Dramatic early favorable response [ Time Frame: 24 (-2/+12 hours) ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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).

Contacts and Locations

Locations

Spain

Hospital Germans Trias i Pujol

Badalona, Spain

Hospital Bellvitge

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

Sponsors and Collaborators

Fundacio Ictus Malaltia Vascular

Medtronic

Anagram-ESIC

UPC

BioClever 2005 S.L.

Investigators

• Principal Investigator: 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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

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. Erratum In: JAMA. 2023 Apr 4;329(13):1123.

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.

• Responsible Party: Fundacio Ictus Malaltia Vascular
• ClinicalTrials.gov Identifier: NCT02795962
• Other Study ID Numbers: RACECAT
• First Posted: June 10, 2016
• Last Update Posted: March 16, 2021
• Last Verified: March 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Fundacio Ictus Malaltia Vascular:

Endovascular Procedures; Emergency Medical Services

Additional relevant MeSH terms:

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