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

March 14, 2021 updated by: Fundacio Ictus Malaltia Vascular

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

1401

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Badalona, Spain
        • Hospital Germans Trias i Pujol
      • Barcelona, Spain
        • Hospital Vall d'Hebron
      • Barcelona, Spain
        • Hospital Clínic
      • Barcelona, Spain
        • Hospital Santa Creu i Sant Pau
      • Barcelona, Spain
        • Hospital Bellvitge
      • Barcelona, Spain
        • Hospital Mar
      • Barcelona, Spain
        • Hospital Moisés Broggi
      • Girona, Spain
        • Hospital Josep Trueta
      • Lleida, Spain
        • Hospital Arnau Vilanova
      • Manresa, Spain
        • Hospital Althaia
      • Terrassa, Spain
        • Mutua Terrassa
      • Tortosa, Spain
        • Hospital Verge de la Cinta

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality in all patients
Time Frame: 90 days
Mortality in all patients included
90 days
Mortality in hemorrhagic stroke patients
Time Frame: 90 days
Mortality in hemorrhagic stroke patients
90 days
Clinical deterioration requiring orotracheal intubation during transfers
Time Frame: 8 hours
Orotracheal intubation during transfers
8 hours
Clinical deterioration
Time Frame: 24 hours
Clinical deterioration (≥4 points on the NIHSS)
24 hours
Reperfusion therapies
Time Frame: 8 hours
Proportion of patients receiving iv tPA and endovascular treatment within the first 8h from symptom onset
8 hours
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).
8 hours
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
90 days
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.
90 days
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.
24 (-2/+12 hours)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundacio Ictus Malaltia Vascular

Collaborators

Medtronic
BioClever 2005 S.L.
Anagram-ESIC
UPC

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 1, 2017

Primary Completion (ACTUAL)

October 1, 2020

Study Completion (ACTUAL)

October 1, 2020

Study Registration Dates

First Submitted

June 1, 2016

First Submitted That Met QC Criteria

June 6, 2016

First Posted (ESTIMATE)

June 10, 2016

Study Record Updates

Last Update Posted (ACTUAL)

March 16, 2021

Last Update Submitted That Met QC Criteria

March 14, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RACECAT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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