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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)

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ClinicalTrials.gov Identifier: NCT02795962
Recruitment Status : Recruiting
First Posted : June 10, 2016
Last Update Posted : March 6, 2017
Sponsor:
Collaborators:
Medtronic
Anagram-ESIC
UPC
BioClever 2005 S.L.
Information provided by (Responsible Party):
Fundacio Ictus Malaltia Vascular

Tracking Information
First Submitted Date  ICMJE June 1, 2016
First Posted Date  ICMJE June 10, 2016
Last Update Posted Date March 6, 2017
Actual Study Start Date  ICMJE March 1, 2017
Estimated Primary Completion Date March 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 6, 2016)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02795962 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 2, 2017)
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 6, 2016)
  • 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 ]
  • 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 of 0-2 or NIHSS improvement ≥ 8 points in ischemic stroke and hemorrhagic stroke patients.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Direct Transfer to an Endovascular Center Compared to Transfer to the Closest Stroke Center in Acute Stroke Patients With Suspected Large Vessel Occlusion
Official Title  ICMJE 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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Condition  ICMJE Stroke
Intervention  ICMJE 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
Study Arms  ICMJE
  • 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.
    Intervention: Other: Direct transfer to an Endovascular Center
  • 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 6, 2016)
1754
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date March 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Natalia Pérez de la Ossa 0034 93 4978911 nperez.germanstrias@gencat.cat
Contact: Marc Ribó mribo@vhebron.net
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02795962
Other Study ID Numbers  ICMJE RACECAT
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Fundacio Ictus Malaltia Vascular
Study Sponsor  ICMJE Fundacio Ictus Malaltia Vascular
Collaborators  ICMJE
  • Medtronic
  • Anagram-ESIC
  • UPC
  • BioClever 2005 S.L.
Investigators  ICMJE
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
PRS Account Fundacio Ictus Malaltia Vascular
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP