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).
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
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Enrollment
1,401
Cluster randomized controlled study: allocation to active or no intervention arm will be performed accordingly to a pre-established temporal sequence
Hospital Germans Trias i Pujol
Badalona, Spain
Hospital Bellvitge
Barcelona, Spain
Hospital Clínic
Barcelona, Spain
Hospital Mar
Barcelona, Spain
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.
Time frame: 90 days
Mortality in all patients
Mortality in all patients included
Time frame: 90 days
Mortality in hemorrhagic stroke patients
Mortality in hemorrhagic stroke patients
Time frame: 90 days
Clinical deterioration requiring orotracheal intubation during transfers
Orotracheal intubation during transfers
Time frame: 8 hours
Clinical deterioration
Clinical deterioration (≥4 points on the NIHSS)
Time frame: 24 hours
Reperfusion therapies
Proportion of patients receiving iv tPA and endovascular treatment within the first 8h from symptom onset
Time frame: 8 hours
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).
Time frame: 8 hours
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
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Hospital Moisés Broggi
Barcelona, Spain
Hospital Santa Creu i Sant Pau
Barcelona, Spain
Hospital Vall d'Hebrón
Barcelona, Spain
Hospital Josep Trueta
Girona, Spain
Hospital Arnau Vilanova
Lleida, Spain
Hospital Althaia
Manresa, Spain
...and 2 more locations
Time frame: 90 days
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.
Time frame: 90 days
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.
Time frame: 24 (-2/+12 hours)