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StrokeRACECATNCT02795962

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

A study testing Direct transfer to an Endovascular Center in people with Stroke, run by Fundacio Ictus Malaltia Vascular at 12 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stroke
What is being tested?
Direct transfer to an Endovascular Center
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,401 participants
Where
12 sitesSpain
Study dates
1 Mar 2017to 1 Oct 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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).

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

Spain12 sites
  • Hospital Germans Trias i Pujol

    Badalona

  • Hospital Bellvitge

    Barcelona

  • Hospital Clínic

    Barcelona

  • Hospital Mar

    Barcelona

  • Hospital Moisés Broggi

    Barcelona

  • Hospital Santa Creu i Sant Pau

    Barcelona

  • Hospital Vall d'Hebrón

    Barcelona

  • Hospital Josep Trueta

    Girona

  • Hospital Arnau Vilanova

    Lleida

  • Hospital Althaia

    Manresa

  • Mutua Terrassa

    Terrassa

  • Hospital Verge de la Cinta

    Tortosa

Other trials in Spain

About this study

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.

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).

Read the 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.

Conditions
Stroke
Being tested
Direct transfer to an Endovascular Center
Keywords
Endovascular Procedures, Emergency Medical Services
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Direct transfer to an Endovascular CenterOther

    Cluster randomized controlled study: allocation to active or no intervention arm will be performed accordingly to a pre-established temporal sequence

Study groups in NCT02795962
Study groupRoleWhat they receive
Transfer to an Endovascular CenterActive comparatorAcute 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.
Receives: Other: Direct transfer to an Endovascular Center
Transfer to the Local Stroke CenterNo interventionAcute 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 90 days

Secondary outcomes (9)
  1. Mortality in all patients

    Mortality in all patients included

    Measured: 90 days

  2. Mortality in hemorrhagic stroke patients

    Mortality in hemorrhagic stroke patients

    Measured: 90 days

  3. Clinical deterioration requiring orotracheal intubation during transfers

    Orotracheal intubation during transfers

    Measured: 8 hours

  4. Clinical deterioration

    Clinical deterioration (≥4 points on the NIHSS)

    Measured: 24 hours

  5. Reperfusion therapies

    Proportion of patients receiving iv tPA and endovascular treatment within the first 8h from symptom onset

    Measured: 8 hours

  6. 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).

    Measured: 8 hours

  7. Subgroup analysis

    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

    Measured: 90 days

  8. 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.

    Measured: 90 days

  9. 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.

    Measured: 24 (-2/+12 hours)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jun 2016 (estimated)
  2. Study start1 Mar 2017
  3. Primary completion1 Oct 2020
  4. Study completion1 Oct 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
1,401 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02795962
Sponsor's protocol ID
RACECAT
Acronym
RACECAT
Status last verified
Mar 2021
First submitted
1 Jun 2016
Last updated
16 Mar 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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 Aug;57(8):2340-2347. doi: 10.1161/STROKEAHA.125.054668. Epub 2026 May 13.

    PubMed 42125807
  • 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.

    PubMed 37603325
  • 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.

    PubMed 36848432
  • 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.

    PubMed 36259411
  • 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.

    PubMed 36053966
  • 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.

    PubMed 35510397
  • 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.

    PubMed 31142219

Questions about this trial

What is this clinical trial studying?

A study testing Direct transfer to an Endovascular Center in people with Stroke, run by Fundacio Ictus Malaltia Vascular at 12 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

modified Rankin Scale score (shift analysis) (time frame: 90 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02795962, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2021.

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