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.
- Direct transfer to an Endovascular Center Other
Intervention Desc: Cluster randomized controlled study: allocation to active or no intervention arm will be performed accordingly to a pre-established temporal sequence ARM 1: Kind: Experimental Label: Transfer to an Endovascular Center 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.
- Allocation: Randomized
- Masking: Single Blind (Outcomes Assessor)
- Purpose: Health Services Research
- Endpoint: Safety/Efficacy Study
- Intervention: Parallel Assignment
|Type||Measure||Time Frame||Safety Issue|
|Primary||modified Rankin Scale score (shift analysis)||90 days||No|
|Secondary||Mortality in all patients||90 days||Yes|
|Secondary||Mortality in hemorrhagic stroke patients||90 days||Yes|
|Secondary||Clinical deterioration requiring orotracheal intubation during transfers||8 hours||Yes|
|Secondary||Clinical deterioration||24 hours||Yes|
|Secondary||Reperfusion therapies||8 hours||No|
|Secondary||Time from symptom onset to reperfusion therapies||8 hours||No|
|Secondary||Subgroup analysis||90 days||No|
|Secondary||Clinical benefit of direct vs. local transfer accordingly with time and distance to the Endovascular Center||90 days||No|
|Secondary||Dramatic early favorable response||24 (-2/+12 hours)||No|