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

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Direct transfer to an Endovascular Center
Sponsored by
Fundacio Ictus Malaltia Vascular
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Stroke focused on measuring Endovascular Procedures, Emergency Medical Services

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Hospital Germans Trias i Pujol
  • Hospital Bellvitge
  • Hospital Clínic
  • Hospital Mar
  • Hospital Moisés Broggi
  • Hospital Santa Creu i Sant Pau
  • Hospital Vall d'Hebrón
  • Hospital Josep Trueta
  • Hospital Arnau Vilanova
  • Hospital Althaia
  • Mutua Terrassa
  • Hospital Verge de la Cinta

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Transfer to an Endovascular Center

Transfer to the Local Stroke Center

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Mortality in all patients
Mortality in all patients included
Mortality in hemorrhagic stroke patients
Mortality in hemorrhagic stroke patients
Clinical deterioration requiring orotracheal intubation during transfers
Orotracheal intubation during transfers
Clinical deterioration
Clinical deterioration (≥4 points on the NIHSS)
Reperfusion therapies
Proportion of patients receiving iv tPA and endovascular treatment within the first 8h from symptom onset
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).
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
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.
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.

Full Information

First Posted
June 1, 2016
Last Updated
March 14, 2021
Sponsor
Fundacio Ictus Malaltia Vascular
Collaborators
Medtronic, Anagram-ESIC, UPC, BioClever 2005 S.L.
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1. Study Identification

Unique Protocol Identification Number
NCT02795962
Brief Title
Direct Transfer to an Endovascular Center Compared to Transfer to the Closest Stroke Center in Acute Stroke Patients With Suspected Large Vessel Occlusion
Acronym
RACECAT
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

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
October 1, 2020 (Actual)
Study Completion Date
October 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundacio Ictus Malaltia Vascular
Collaborators
Medtronic, Anagram-ESIC, UPC, BioClever 2005 S.L.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Endovascular Procedures, Emergency Medical Services

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
1401 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Transfer to an Endovascular Center
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Transfer to the Local Stroke Center
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Direct transfer to an Endovascular Center
Intervention Description
Cluster randomized controlled study: allocation to active or no intervention arm will be performed accordingly to a pre-established temporal sequence
Primary Outcome Measure Information:
Title
modified Rankin Scale score (shift analysis)
Description
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.
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Mortality in all patients
Description
Mortality in all patients included
Time Frame
90 days
Title
Mortality in hemorrhagic stroke patients
Description
Mortality in hemorrhagic stroke patients
Time Frame
90 days
Title
Clinical deterioration requiring orotracheal intubation during transfers
Description
Orotracheal intubation during transfers
Time Frame
8 hours
Title
Clinical deterioration
Description
Clinical deterioration (≥4 points on the NIHSS)
Time Frame
24 hours
Title
Reperfusion therapies
Description
Proportion of patients receiving iv tPA and endovascular treatment within the first 8h from symptom onset
Time Frame
8 hours
Title
Time from symptom onset to reperfusion therapies
Description
Time from symptom onset to iv tPA administration (for patients treated with iv tPA) and to groin puncture (for patients treated with endovascular).
Time Frame
8 hours
Title
Subgroup analysis
Description
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
Time Frame
90 days
Title
Clinical benefit of direct vs. local transfer accordingly with time and distance to the Endovascular Center
Description
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.
Time Frame
90 days
Title
Dramatic early favorable response
Description
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.
Time Frame
24 (-2/+12 hours)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc Ribó, PhD
Organizational Affiliation
Hospital Universitari Vall d'Hebrón, Barcelona, Spain
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sonia Abilleira, PhD
Organizational Affiliation
Pla Director Malaltia Vascular Cerebral. Agència de Qualitat i Avaluació Sanitàries de Catalunya (AQuAS)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Natalia Pérez de la Ossa, PhD
Organizational Affiliation
Hospital Universitari Germans Trias i Pujol, Badalona, Spain
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Germans Trias i Pujol
City
Badalona
Country
Spain
Facility Name
Hospital Bellvitge
City
Barcelona
Country
Spain
Facility Name
Hospital Clínic
City
Barcelona
Country
Spain
Facility Name
Hospital Mar
City
Barcelona
Country
Spain
Facility Name
Hospital Moisés Broggi
City
Barcelona
Country
Spain
Facility Name
Hospital Santa Creu i Sant Pau
City
Barcelona
Country
Spain
Facility Name
Hospital Vall d'Hebrón
City
Barcelona
Country
Spain
Facility Name
Hospital Josep Trueta
City
Girona
Country
Spain
Facility Name
Hospital Arnau Vilanova
City
Lleida
Country
Spain
Facility Name
Hospital Althaia
City
Manresa
Country
Spain
Facility Name
Mutua Terrassa
City
Terrassa
Country
Spain
Facility Name
Hospital Verge de la Cinta
City
Tortosa
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
36259411
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.
Results Reference
derived
PubMed Identifier
36053966
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.
Results Reference
derived
PubMed Identifier
35510397
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. Erratum In: JAMA. 2023 Apr 4;329(13):1123.
Results Reference
derived
PubMed Identifier
31142219
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.
Results Reference
derived

Learn more about this trial

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

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