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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)

This study is currently recruiting participants.
Verified March 2017 by Fundacio Ictus Malaltia Vascular
Sponsor:
ClinicalTrials.gov Identifier:
NCT02795962
First Posted: June 10, 2016
Last Update Posted: March 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Medtronic
Anagram-ESIC
UPC
Bioclever
Information provided by (Responsible Party):
Fundacio Ictus Malaltia Vascular
  Purpose
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 Intervention
Stroke Other: Direct transfer to an Endovascular Center

Study Type: Interventional
Study Design: 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.

Further study details as provided by Fundacio Ictus Malaltia Vascular:

Primary Outcome Measures:
  • 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:
  • Mortality in all patients [ Time Frame: 90 days ]
    Mortality in all patients included

  • Mortality in hemorrhagic stroke patients [ Time Frame: 90 days ]
    Mortality in hemorrhagic stroke patients

  • Clinical deterioration requiring orotracheal intubation during transfers [ Time Frame: 8 hours ]
    Orotracheal intubation during transfers

  • Clinical deterioration [ Time Frame: 24 hours ]
    Clinical deterioration (≥4 points on the NIHSS)

  • Reperfusion therapies [ Time Frame: 8 hours ]
    Proportion of patients receiving iv tPA and endovascular treatment within the first 8h from symptom onset

  • 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).

  • 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

  • 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.

  • 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.


Estimated Enrollment: 1754
Actual Study Start Date: March 1, 2017
Estimated Primary Completion Date: March 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02795962


Contacts
Contact: Natalia Pérez de la Ossa 0034 93 4978911 nperez.germanstrias@gencat.cat
Contact: Marc Ribó mribo@vhebron.net

Locations
Spain
Hospital Germans Trias i Pujol Recruiting
Badalona, Spain
Contact: Natalia Pérez de la Ossa         
Hospital Bellvitge Recruiting
Barcelona, Spain
Contact: Pere Cardona         
Hospital Clínic Recruiting
Barcelona, Spain
Contact: Xabier Urra         
Hospital Mar Recruiting
Barcelona, Spain
Contact: Ana Rodríguez-Campello         
Hospital Moisés Broggi Recruiting
Barcelona, Spain
Contact: Sonia Garcia         
Hospital Santa Creu i Sant Pau Recruiting
Barcelona, Spain
Contact: Joan Martí Fàbregas         
Hospital Vall d'Hebrón Recruiting
Barcelona, Spain
Contact: Marc Ribó         
Hospital Josep Trueta Not yet recruiting
Girona, Spain
Contact: Joaquín Serena         
Hospital Arnau Vilanova Not yet recruiting
Lleida, Spain
Contact: Francisco Purroy         
Hospital Althaia Not yet recruiting
Manresa, Spain
Contact: Júlia Saura         
Mutua Terrassa Recruiting
Terrassa, Spain
Contact: Jerzy Krupinski         
Hospital Verge de la Cinta Not yet recruiting
Tortosa, Spain
Contact: Josep Zaragoza         
Sponsors and Collaborators
Fundacio Ictus Malaltia Vascular
Medtronic
Anagram-ESIC
UPC
Bioclever
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

Responsible Party: Fundacio Ictus Malaltia Vascular
ClinicalTrials.gov Identifier: NCT02795962     History of Changes
Other Study ID Numbers: RACECAT
First Submitted: June 1, 2016
First Posted: June 10, 2016
Last Update Posted: March 6, 2017
Last Verified: March 2017
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
Glucuronyl glucosamine glycan sulfate
Anticoagulants
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Hypoglycemic Agents
Physiological Effects of Drugs